Ep206: Lyn Baranowski on Inhalable Medicines for Severe Lung Diseases

Lynn Baranowski traces her unconventional path to leading a respiratory drug development company. Growing up in a small New Hampshire town, she initially pursued law and languages, eventually studying at American University and Harvard Business School. After eight years in international affairs and diplomacy, she identified biotech as an industry meeting her specific criteria: intellectual complexity, mission-driven work, international scope, and heavy regulation. Her first biotech role at Novartis exposed her to respiratory diseases, particularly pulmonary fibrosis, which she found criminally underserved despite being a fatal disease with only three to five year survival.

Baranowski gained experience at multiple companies including Pearl Therapeutics and Altavant before joining Avalon, where she inherited a struggling company with limited resources. She faced the hardest nine months of her career, performing layoffs and developing a new strategic plan while raising $175 million in Series funding nine months later, ultimately taking the company public. Avalon's core strategy involves reformulating two FDA-approved oral drugs—pirfenidone and nintedanib—as inhalable treatments using a PARI nebulizer platform.

The rationale is compelling: pirfenidone and nintedanib are commercial successes (Ofev generates $4 billion annually), yet only about 30% of patients are treated at any given time and only 10% remain on therapy annually. Oral administration causes severe tolerability issues—pirfenidone causes nausea and vomiting while nintedanib causes debilitating diarrhea. In a patient population that is older, frail, with limited breathing capacity, these side effects effectively force patients to abandon therapy. By inhaling these drugs directly to lung tissue, Avalon can reduce pirfenidone dosing from 2,400mg daily to 200mg daily while achieving superior lung exposure and eliminating systemic side effects. Nintedanib shows even more dramatic improvements: 27 times higher lung exposure despite reducing the dose from 150mg to 4mg.

Baranowski explains the technical advantages of their approach, including multiple layers of patent protection from the drug formulation itself, exclusivity with the device manufacturer, drug-device combination patents, and FDA barriers to generic entry for nebulized inhalers that require large clinical trials. Early phase 1B data (the ATLAS study) showed lung function stabilization over one year (0.4% decline versus 7% decline on placebo), with some patients remaining stable on drug for six years—remarkable given the disease's typical three to five year survival. The company is advancing three programs: AP01 (inhaled pirfenidone), AP02 (inhaled nintedanib), and AP03 (a fixed-dose combination), with phase 2 data expected in the second half of 2027.

Baranowski emphasizes that patient feedback supports inhaled delivery, noting that patients feel agency and control by actively inhaling medication. She discusses the much larger addressable market than currently treated—the U.S. pulmonary fibrosis market represents $42 billion annually (300,000 patients × $150,000 per patient), yet current drugs capture only a fraction. She mentions broader opportunities in other interstitial lung diseases and aspires to build "the next INSMED," referencing a respiratory company that successfully commercialized NTM and recently launched a bronchiectasis treatment. Throughout the interview, she emphasizes the importance of grit, resilience, curiosity, humility, and people management in navigating biotech entrepreneurship.