RARE Daily

Avalyn Raises $175 Million to Advance Inhaled Pulmonary Fibrosis Programs

September 27, 2023

Rare Daily Staff

Avalyn Pharma, a clinical-stage company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, closed an oversubscribed $175 million series C financing.

Perceptive Xontogeny Venture Funds, SR One, and Eventide Asset Management co-led the financing, joined by new and current investors. In conjunction with the financing, Gianna Hoffman-Luca of Perceptive Xontogeny Venture Funds, and Jill Carroll of SR One, joined Avalyn’s Board of Directors.

Avalyn plans to use the funds to continue development of its portfolio of inhalation therapies for interstitial lung disease that improve upon currently approved medications, and advance lead clinical assets, AP01 (inhaled pirfenidone) and AP02 (inhaled nintedanib), into mid-stage clinical trials.

“Pulmonary fibrosis is a fatal disease with a median survival of only three to five years. Fewer than 30 percent of patients in the U.S. are treated with either of the two approved oral medicines today due to their significant tolerability challenges,” said Lyn Baranowski, CEO of Avalyn. “There is an urgent need for effective treatments that patients can tolerate, which we believe can be addressed with inhaled delivery. In fact, our existing clinical data shows potential for both improved tolerability and efficacy.”

While oral pirfenidone has been shown to reduce decline of lung function and mortality in patients with idiopathic pulmonary fibrosis (IPF), systemic exposure contributes to significant side effects including nausea, rash, photosensitivity, weight loss, and fatigue, limiting its overall use in patients. In clinical trials to date, inhaled AP01 has been well-tolerated and demonstrated enhanced efficacy, when compared to published results of oral pirfenidone. Additionally, AP02 was well-tolerated in a recently completed open-label phase 1a trial in IPF patients and healthy volunteers. Avalyn plans to advance AP01 into a phase 2b trial and AP02 into a phase 2a trial for patients with pulmonary fibrosis.

Photo: Lyn Baranowski, CEO of Avalyn

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