Catalio Conversations
How Inhaled Medicine is Transforming Treatment for Rare Lung Disease w/ Lyn Baranowski CEO of Avalyn
What if the biggest problem in pulmonary fibrosis isn't finding a drug that works — but getting patients to stay on the ones we already have? In this episode of Catalio Conversations, Martha Petrocheilos sits with Lyn Baranowski, CEO of Avalyn Pharma, who makes a contrarian case: two effective medicines have been approved for a decade, yet fewer than 10% of diagnosed patients are still taking them a year later — because the oral formulations are so poorly tolerated that patients simply stop. In a disease with three-to-five-year survival, worse than most cancers, the rate limiter isn't the science. It's the delivery. Lyn's path — from business development at Novartis, through leadership at Pearl before its billion-dollar acquisition by AstraZeneca, to COO at Altavant — is two decades spent almost entirely in respiratory, and it shapes how she reads this market. Avalyn's approach takes pirfenidone and nintedanib and reformulates them for inhalation, putting the drug directly into the lung and cutting the dose dramatically: pirfenidone drops from 2,400 mg a day orally to 200 mg inhaled. Lead program AP01 has now been studied in more than 150 patients, some on therapy beyond five years, with imaging showing stabilization or reversal of fibrosis in 70% of patients on the high dose. Phase 2b data reads out in the second half of 2027, and the company recently went public on NASDAQ in one of the year's largest biotech IPOs, raising roughly $345 million. Perfect for healthcare leaders, biotech investors, and anyone curious about how drugs actually reach patients, this episode makes the case that reformulation is not a tweak but a bet — and that solving tolerability is what finally unlocks combination therapy in a disease that has never been able to use it. Timestamped Summary: 00:07 — Introduction to Lyn Baranowski and Avalyn Pharma, which develops inhaled therapies for rare lung diseases 01:26 — Lynn explains how early respiratory work at Novartis introduced her to pulmonary fibrosis and its unmet need 02:31 — Lessons from asthma and COPD point toward combination treatment in pulmonary fibrosis 03:37 — What drew her to Avalyn: delivering established medicines straight to the lung to keep patients on therapy 04:14 — A patient advisory council reviews protocols and keeps patient needs at the center of strategy 05:19 — Existing oral therapies cause side effects severe enough that most patients stop taking them 05:53 — Avalyn reformulates proven drugs for inhalation, raising lung exposure while cutting the dose 07:02 — Day-to-day treatment is a soft nebulized mist breathed in over about eight minutes 08:38 — Hiring people who developed the original oral drugs gave the team rare disease-specific expertise 09:11 — Fewer than 10% of patients remain on oral therapy at a year, while some Avalyn patients have stayed on beyond five 10:25 — The longer-term goal is making combination treatment practical, as it already is in other lung diseases 11:02 — Clinical data show stabilized lung function and, on imaging, stabilization or reversal of fibrosis 12:06 — The Phase 2b study aims to prove better tolerability alongside sustained lung-function benefit 13:12 — Inhaled reformulation is technically demanding and hard for generic competitors to replicate 14:56 — Doctors need clinical evidence, while patients intuitively grasp the logic of medicine going straight to the lungs 16:03 — Lyn discusses Avalyn's NASDAQ debut and what investors responded to 18:44 — Beyond pulmonary fibrosis, many rare lung diseases still have nothing approved 19:56 — Imaging suggests pirfenidone may help earlier, before fibrosis fully sets in 20:32 — Quick-fire close: her bet is that inhaled delivery unlocks combination treatment
