Latest / The BioHub - by Avetix / Episode 105 - Ahmet Tutuncu - CEO of AeroRx Therapeutics

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Episode 105 - Ahmet Tutuncu - CEO of AeroRx Therapeutics · The BioHub - by Avetix

• 0:04
  On this episode of the Bio Hub podcast, we're joined by Ahmed
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  Tutankhu of Aero RX. Aero RX just raised 21,000,000
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  Series A to fund late stage clinical development of the lead
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  asset, which is in COPD. Ahmed, welcome to the pod.
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  Just to get started, Ahmed. Yeah, I guess it's always
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  helpful if we go back to not necessarily to start, but yeah,
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  just to give a little bit of background to yourself and your
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  journey through from being a physician right to being
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  involved in early stage biotech. Right in my training, I'm a
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  critical care physician and train and practice medicine in
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  Turkey, University of Istanbul, and I actually did my PhD in
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  respiratory photophysiology at the Erasmus University in
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  Retford. I'm in Netherlands and then I
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  was a faculty at the University of Istanbul and with my research
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  focus, I was invited to be part of a biotech company here in San
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  Diego. This is almost 30 years ago and
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  I joined the company and then became part of the biotech
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  community in San Diego since then.
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  So I was fortunate enough to be part of the teams companies
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  involved in respiratory drug development.
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  And then the last two companies I was a Co founder and we
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  developed middleized medicines. Both companies successfully
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  acquired and with that background obviously we decided
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  to move on to the next and RX is obviously which we're working on
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  right now is a Co founder and extending our work experience in
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  the space was a new dual combination drug product for
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  nebulization delivery for COPD patients.
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  So my passion has been always around, you know, inhaled drug
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  delivery, drug device combination products and
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  bringing about new medicines for those patients who really need
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  these stabilized therapies, primarily nebulized therapies
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  because of the advantages over inhaler therapies.
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  So that's why we are now and trying to again develop a new
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  bronchodilator. Dual bronchodilator is a first
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  line therapy therapy for those COPD patients who are sicker and
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  older and who would need to be on nebulized medicines or prefer
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  to be on nebulized medicines. Understood.
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  And I mean you're quite modest, right.
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  I mean you've been involved in two companies that you've you Co
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  founded like you say and you took them through to
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  acquisition. You're a real true specialist in
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  the respiratory space, right. Why obviously you've been
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  successful. Why did you choose to jump back
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  in with Aro RX? What was promising about the
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  technology or the platform or the team, whatever it was?
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  Yeah. What sort of come to you to
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  start the journey all over again?
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  Yeah, it's an, I think that's an interesting, you know, history
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  with the, you know, company that I was a Co founder that was back
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  in 10 plus years ago Elevation Pharma where we developed and
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  nebulized bronchodilator for such sort of COPD patients.
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  That was a single bronchodilator and that was actually a
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  Muscariga antagonist. That was the standard of care
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  that time being the, you know, first line therapy for COPD
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  patients. And then over the last 10 years,
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  10th last years, the treatment paradigm has really evolved to
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  dual bronchodilators for the COPD patients as the first line
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  therapy. And we do have some medicines
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  available, dual broker dilators available in inhalers, hand
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  inhalers, but not for nebulization delivery.
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  So we came up with this idea with a combination drug product
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  for nebulization delivery and that was for me like you know,
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  Elevation Pharma, you know, 2 point O.
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  So that was really expanding on that experience we had with
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  Elevation Pharma with the mono bronchodilator.
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  And we've been always thinking about, you know, dual Bronco
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  Taylor and this was perhaps the right time, the right place and
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  I became part of the team. And so this is really, you know,
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  evolved from that, you know, earlier experience at Elevation
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  Pharma. So, so excited about being able
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  to be part of that, you know, journey.
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  Yeah, nice. You mentioned the availability
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  of the in inhalers, but obviously that disqualifies, I
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  guess we were talking about this before, right?
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  That disqualifies the real quite severe COPD patients, right?
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  They're not able to, you know, pick up an inhaler and use it as
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  easily. Just explain a little bit about
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  the patient population you're targeting, right?
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  Because it's pretty severe, the disease.
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  Right. That's really the the unmet need
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  that we've identified. And just maybe take a step back,
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  these patients rely on these medicines again, primarily
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  bronchodilators and sometimes some patients would also need an
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  anti-inflammatory agent like an inhaled corticosteroid.
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  Generally speaking, these medicines are available in
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  handheld inhalers. These are portable small, you
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  know, pocket size inhalers are like dry powder inhaler or meter
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  dose inhaler or soft mist inhalers, easy to use, portable
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  and you know, a lot of patients probably will be comfortable
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  using that. But you that those inhalers
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  require some level of coordination and and also some
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  effort, breathing effort to be able to get the full dose and
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  you only get one or two puffs from from inhaler.
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  So that's why you really need to be well coordinated when you
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  actuate the device and start inhaling younger patients, no
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  problem, they'll be able to use these inhalers.
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  But for especially COPD patients who are typically older and
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  especially those sicker patients they are with, you know,
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  cognitive impairment, dexterity issues, age and other
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  comorbidities, those patients are unable to use these
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  inhalers, handheld inhalers effectively.
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  And those, this has been studied again and again, you know, about
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  75% of these COPD patients typically, again, older patients
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  have made critical errors when they're using these inhalers.
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  And most importantly, these are the patients typically end up
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  with exacerbations and end up in the ER and hospitalized and
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  taken care of. And when they're sent home,
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  discharged home, they're typically sent home with a
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  nebulizer. And the, the reason, primary
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  reason for that is obviously these patients will do better on
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  a nebulizer because of the effortless tidal passive
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  breathing. It just takes maybe 4 or 5
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  minutes, you just continue to inhale and you know that you're
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  going to get the full dose at the end of that five minute
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  delivery. And these patients within
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  minutes, 5 minutes, 10 minutes, they will feel the relief that
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  they're getting the full dose. So that's the really the the
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  target population for us, those again sicker older patients who
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  really need to be on nebulized, nebulized medicines or prefer to
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  be nebulized medicines because they know they're getting the
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  drug full dose and getting immediate relief.
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  Got you. But there's no at the moment, at
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  least until you guys come along, there's no dual acting agonist
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  at that. Yeah.
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  So that's, that was the, the unmade need that we identified
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  that there are five, at least 5 brochodilators, dual
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  bronchodilators food here in the US, but they're all in an
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  inhaler and there is none for nebulization delivery.
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  And that was the unmade need we've identified and decided to
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  go after that and we've obviously identified the
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  molecules. These are two brochodilators
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  well known to the community, the scientific clinical community.
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  So we just combined it to well known actives together for
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  nebulization delivery. Obviously it was not an easy
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  task to put a formulation which will be, you know, enable you to
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  form nebulize. And that was obviously the know
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  how we, we were able to put together that, you know, the
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  formulation, the right composition and then we were
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  able to get, you know, patent claims issued.
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  And that obviously allowed us to, you know, raise capital and
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  then take it to the next level, do all the work.
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  So that's really the crux of the, you know, the company, you
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  know, we're excelling in, in nebulized delivery of medicines
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  for those patients who are who'd really need to be on nebulized
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  medicines typically sicker older patients.
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  Understood. And and what, what have you seen
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  when you've taken this into patients so far with the with
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  the trials that you've done be that in preclinical or or phase
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  one, what sort of early signs have you seen you know of, of
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  action there? Right.
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  So last year in May 2024, we raised the seed round, 6.5
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  million seed round and that enabled us to really finalize
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  the formulation composition and then manufacture the study drug.
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  And then we did a phase one study in healthy volunteers
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  followed by a proof of concept, a Phase 2A study in COPD
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  patients. So that was obviously the, the
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  most major, you know, activity for us over the last year and a
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  half. And 1st, in health volunteers we
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  established you know the doses that we think will be optimal to
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  take it into the patients. Again, these molecules are well
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  known and therefore safety has been well demonstrated.
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  Polar really has been well demonstrated.
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  So it was for us really putting the two together in a new
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  formulation and in the Phase 2A study, a single dose that if we
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  tested 2 doses of our combination drug product at low
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  and high doses against placebo. So this was a randomized
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  placebo-controlled single dose study in 16 COPD patients.
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  And then at the end we were able to demonstrate a robust broken
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  dilation response and sustained over 24 hours.
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  That's obviously an important, you know, check the box for us
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  that we were able to demonstrate efficacy and tolerability in the
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  target population. And these patients were already
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  on, you know, triple therapies, some most of them are triple
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  therapies, but they were taken off their bronchodilators during
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  the study. So these were definitely
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  moderate to severe COPD patients, you know, in terms of
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  their severity of their disease. So obviously we were pleasantly
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  surprised with the response, the robust response, broccoli
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  response and also sustained over 24 hours.
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  So that's why now going forward, we're going to continue to
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  develop this combination drug for I guess once daily.
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  But that was really the all the work that we've done over the
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  last year and a half. And then with that data,
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  obviously this package allowed us to go back to the masters and
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  and raise the Series A for, you know, continuing with the rest
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  of the development activities. And has all that work before
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  been done on the seed funding that that you raised initially?
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  That's right. So that 6.5 million allowed us
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  to do all that, you know, formulation work, phase one
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  clinical, phase two way clinical work and all the regulatory
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  obviously and the team. So yes, it was a small budget,
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  but again very efficient and with the expert team around the
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  table, we were able to really make good progress.
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  Again, this is again what we would want to do, continue to do
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  going forward, being more efficient and you know,
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  delivering in a timely manner, in a quality manner, yeah.
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  Well, I mean capital efficiency has been a fairly big theme in
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  biotech throughout the past 18 months, couple of years, right.
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  So yeah, that's great to see. I mean with the Series A raise
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  that obviously funds the the next trials.
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  But longer term, where are you looking with the program?
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  Are you looking to take it to market yourselves potentially or
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  what's the longer term plan? So again, the Series A
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  21,000,000 Series A we raised by way obviously thanks to Avalon
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  Bio Ventures, the correlation ventures and the Alexandria,
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  obviously they, you know, were supportive of our mission, you
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  know, to continue to develop this drug for those patients who
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  are really in, you know, high need for this, for this type of
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  medic medicines for nebulization.
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  And with their support now we're going to start you know late
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  stage development activities, the 1st and immediate focus
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  being the phase to the clinical trial that we will be conducting
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  this coming year. And also obviously all the work
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  that's required for an end of phase two meeting with the with
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  the Regulatory agency here in the US.
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  So that's our really target to have a successful end of Phase 2
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  be enabling package over the last year, year and a half.
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  So that will involve again all the manufacturing CMC work plus
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  clinical work plus at bridging tox study that we will do for
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  for regulatory purposes. So that's the goal.
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  And then following the end of phase two meeting, obviously
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  we're going to continue with our phase three program.
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  And currently obviously our goal is, you know stay heads down and
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  you know, yeah, go full speed ahead and do the work and a
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  successful NDA filing at the end.
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  But we'll be opportunistic and if there are potential, you
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  know, partnering, you know possible, you know, interest,
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  then we will definitely entertain that.
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  But our goal is to take it all the way through NDA and
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  potentially partner with big pharma for marketing sales.
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  So we are not in the business of really putting together a sales
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  force and, and becoming a really a big pharma for commercial drug
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  products. So our, you know, interest and
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  our motivation is always, you know, developing drugs and then
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  hand it over to, you know, experts who know, you know, the
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  stale part better than us. So that's that's really the
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  goal. Oh great no thanks for the
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  explain. I know it's a, a tricky question
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  to answer sometimes because all options are on the table, right.
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  They sort of have to be given, given the current market.
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  I mean talking of the market, there has been a little bit of a
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  renewed focus on COPD recently, which I guess is a benefit to
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  you guys. It's not necessarily in
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  competition, right, but you sort of expedition raise and and
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  whatnot. So it's, it's great to have that
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  renewed focus on on the space and and ultimately the patients
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  as well. Yeah, that was really a great,
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  you know, summer for us, I should say for the, you know,
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  COPD and respiratory space and for the patients because two big
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  pharma, Merck first acquired company called Verona Pharma who
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  was developing A nebulized medicine Phosphodiazora 3-4
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  inhibitor for COPD patients that which is you know bronchodilator
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  slash an anti-inflammatory agent as an add on treatment.
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  And then that was in July and and that was a really big
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  accusation. You know, Merck paid $10 billion
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  for Verona Pharma and then following that again in the same
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  month, GSK licensed out 12th potential, you know,
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  opportunities including another COPD drug from a Chinese company
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  and for again a nebulized right product for COPD.
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  So that created a lot of interest and I think excitement
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  and momentum in the space. And obviously that's also, you
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  know, probably helped us also raise capital and create a lot
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  of interest, you know, from investors.
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  So that was really, I think it validated the interest on big
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  Pharma in the space, not in respiratory, but also in COPD
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  space, because I think we all realized there are huge unmet
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  needs for these patients, even though we have great medicines
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  currently available. But still these are again,
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  they're about 8.5 million COPD patients in the US who are on
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  maintenance therapy just for the US.
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  It's a. It's a obviously a big
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  population and almost half of these patients are still
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  symptomatic despite the fact that we have these, you know,
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  medicines available for as an inhaler delivery.
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  So that tells you that there's really a huge unmade need for
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  better improvement and improvement on, you know,
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  delivery and also new medicines and we RX.
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  We believe that the delivery system is an important part of
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  the treatment paradigm. In other words, not just the
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  molecules, but not just the active ingredients, but also how
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  you deliver it. So that's why combination of the
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  drug with a better delivery system we think will make a big
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  difference for those patients or again symptomatic despite the
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  fact that they're on these maintenance therapies.
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  So and also a huge unmet need for anti-inflammatory agents.
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  So that's really. What you know the space needs
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  going forward our medication is going to be first line treatment
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  for all these COPD patients. So that's really I think the
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  important you know differentiator are are
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  differentiating us from the other companies currently
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  working in the netalyzer medicine space.
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  But I think from speaking to you, I mean, I mean, both on the
• 20:25
  podcast and and outside of it, I think, yeah, your care for the
• 20:29
  patient population really comes across and the usability of the
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  products you're developing plays a massive part in that.
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  And yeah, it's definitely refreshing to see someone.
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  It's probably your background, right?
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  But refreshing to see someone so focused on delivering for an
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  entire patient population for sure.
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  That's right. So that's our again, that's our
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  mission. And I think this financing
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  Series A financing is going to be more because you know, one
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  more step closer to achieving our goal.
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  And and all by the way, we're also working on a triple
• 21:09
  combination product in addition to the two bronchodilators,
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  adding an inhaled corticosteroid as an anti-inflammatory agent
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  for those patients who need to step up or are still symptomatic
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  on you know, dual bronchodilators and or there's
• 21:30
  an eosinophilic endotype to their inflammation in their
• 21:35
  lungs. And those are again a small
• 21:38
  subset of patients, but nevertheless, those are the
• 21:41
  patients who need to be on these triple medicines, including an
• 21:45
  anti-inflammatory agent. So that's why we're excited
• 21:48
  about the pipeline opportunity with our triple combination
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  product in development and we're doing all the, you know,
• 21:55
  formulation work for selecting the lead formulation to take it
• 21:59
  into an early stage clinical awesome program.
• 22:04
  Nice, I should have known you'd have something else up your
• 22:06
  sleeve as well. Yeah.
• 22:09
  We, we never stop thinking. We always obviously look for
• 22:12
  what else you know and potential pipeline expansion
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  opportunities. So that's you have to, that's
• 22:19
  why we're excited about that. Yeah, nice, Awesome.
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  Well, look, it's been great to have you all and I think we'll
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  probably wrap it up there, but we'll finish with the the
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  standard Biohub question, if you don't mind.
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  Obviously gave you some prep time on it, so don't worry too
• 22:33
  much. But yeah, it was if you could
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  have dinner with any scientist or entrepreneur, if he'd like
• 22:40
  past or present, who would it be and why?
• 22:47
  Yeah, I'm sure there are so many scientists, you know, Marvel
• 22:52
  laureates that I would love to spend some time with.
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  But I think I want to say probably Jane Goodall,
• 23:02
  anthropologist, humanitarian, scientist, who really helped us
• 23:08
  see the world, the planet from different set of eyes, you know,
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  help us, you know, understand that every living being has
• 23:17
  emotions and that every living being can make a difference.
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  So that's why it made me to look at the, you know, the the world
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  in a different view. So I really admire her work.
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  And I would, I'd love to have, you know, a dinner or a
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  breakfast with her. Unfortunately, we passed away a
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  couple weeks ago, so rest in peace, Jane.
• 23:44
  Yeah, very poignant. I mean, yeah, great choice.
• 23:47
  I don't think we've had that one before, but again, I think it
• 23:49
  shows. Yeah, a little bit about yeah,
• 23:52
  how how you see the world for sure.
• 23:54
  So I appreciate it. It's been fantastic having you
• 23:57
  on Ahmed and looking forward to staying in touch.
• 24:01
  Thanks for having me. Good to be with you.
• 24:04
  Thank you, Phil.