Ep206: Lyn Baranowski on Inhalable Medicines for Severe Lung Diseases

Episode Summary

Executive Summary: Lynn Baranowski describes her path from diplomacy and international affairs into biotech, then details how Avalyn Pharma is developing inhaled versions of approved oral antifibrotic drugs to treat severe lung diseases like IPF. She argues inhaled delivery can improve lung exposure, reduce systemic toxicity, and create durable commercial franchises in an underserved field.

Main Topics: Baranowski’s unconventional path into biotech (Priority: 5/5): She grew up in small-town New Hampshire, studied international affairs and French, worked in diplomacy, then discovered biotech through MBA projects focused on global health and policy. Why respiratory medicine became her career focus (Priority: 5/5): At Novartis and other companies, she developed a lasting passion for respiratory disease because it combines high unmet need, scientific complexity, and durable business opportunities. Learning to translate science across functions (Priority: 4/5): Baranowski emphasizes curiosity, humility, and the ability to explain complex biology in plain language as core skills for business development and leadership. Avalyn’s inhaled reformulation strategy (Priority: 5/5): Avalyn is converting oral drugs for pulmonary fibrosis into inhaled therapies to deliver medication directly to the lungs, reduce dose, and improve tolerability. Clinical and commercial rationale in IPF (Priority: 5/5): She explains that current oral IPF drugs work but are poorly tolerated and used by only a minority of patients, leaving a large unmet-need market for better delivery approaches. IPO, pipeline expansion, and next steps (Priority: 4/5): The IPO funded late-stage development of AP01 and AP02 and enabled preparation for phase 3, while AP03 explores a fixed-dose combination strategy.

Key Arguments: Respiratory disease is underserved: there are many lung diseases with limited treatment options, especially rare fibrotic conditions. Inhaled delivery can improve the therapeutic index by increasing drug concentration at the target organ while reducing systemic exposure and side effects. Inhaler/device combinations create scientific and regulatory complexity that can support durable IP and reduce generic competition. Current oral IPF drugs are effective but poorly tolerated, so many patients discontinue quickly or never start therapy. A nebulized approach is particularly well suited for frail IPF patients because it is gentler, customizable, and relies on normal breathing rather than forceful inhalation. Long-term adherence and stable lung function data suggest inhaled reformulation may materially improve real-world outcomes. Combination therapy is likely the future of lung disease treatment, and inhaled versions of proven drugs can serve as a backbone for broader regimens. Baranowski’s leadership style centers on curiosity, translating science clearly, and building high-quality teams.

Data Points: Population with diagnosed pulmonary fibrosis in the U.S.: ~300,000 patients per year - Used to illustrate the scale of the addressable market for pulmonary fibrosis therapies. Lowest brand pricing in the marketplace today: ~$150,000 per patient per year - Referenced as a benchmark for current branded pulmonary fibrosis therapies. Implied U.S. market size: ~$42 billion - Calculated by multiplying 300,000 patients by $150,000 annually, assuming one drug per patient. Survival in pulmonary fibrosis: 3 to 5 years - Baranowski described IPF as a rare, deadly disease with poor prognosis. Untreated lung function decline: ~7% per year - Average annual decline in lung function on placebo/untreated disease. Oral pirfenidone effect in ASCEND: ~3% annual decline - Shows the oral drug slows, but does not stop, decline in lung function. ATLAS study lung function result: 0.4% decline over one year - Phase 1B patient study suggesting near-stabilization with inhaled AP01. Patients remaining in long-term open-label extension: 23 of 100 - Long-term follow-up data after patients entered the extension study. Approximate time some patients stayed on drug: About 6 years - Demonstrates sustained adherence and extended exposure in the open-label extension. Inhaled vs oral nintedanib exposure: 27x higher Cmax and AUC - Preclinical/clinical exposure data cited for inhaled delivery versus oral dosing. Oral to inhaled pirfenidone dose reduction: 2400 mg/day to 200 mg/day - Example of how inhalation enables a much lower dose with better target-organ delivery. Oral to inhaled nintedanib dose reduction: 150 mg to 4 mg - Illustrates dramatic dose reduction with inhaled formulation. AP01 issuance/patent status: 11 issued patents, 2 pending - Baranowski described intellectual property protection around the inhaled formulation. Drug development timeline: Phase 2B data in 2H 2027; AP02 data late 2027; AP03 phase 1 start late this year - Projected milestones following the IPO and capital raise. Capital raised after IPO: $175 million - Funds secured to advance AP01, AP02, AP03 and prepare for phase 3.

Pivotal Quotes: "Lung disease is an important area that needs more research and development, so something I'm really passionate about." — Lynn Baranowski: Explaining why respiratory medicine remains her career focus. "What we're fundamentally doing at Avilin is taking drugs that we know work, but delivering them in a much more sensible way that allows us to resolve the issues that are the challenges for patients." — Lynn Baranowski: Summarizing Avalyn’s core strategy for inhaled reformulation. "People are the most important thing." — Lynn Baranowski: Describing the leadership lesson she learned in business school and applies in biotech management.

Implications: Avalyn’s approach could expand treatment access in IPF by making proven drugs tolerable and durable. If the inhaled data hold, it may reshape respiratory drug development around delivery, adherence, and combination therapy.