Avalyn Pharma secured $175m in a Series C financing round to fund the clinical development of inhaled pulmonary therapies.

The US-based company plans to advance idiopathic pulmonary fibrosis (IPF) therapies, AP01 (inhaled pirfenidone) and AP02 (inhaled nintedanib), to Phase IIb and IIa trials, respectively.

Approved oral drugs—Roche’s Esbriet/Pirespa (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib)—are commonly used to reduce scarring. Avalyn is developing inhaled formulations in an effort to reduce the systemic side effects of the drugs. Avalyn CEO Lyn Baranowski highlighted the need for an alternate mode of administration stating: “Fewer than 30% of patients in the US are treated with either of the two approved oral medicines today due to their significant tolerability challenges.”

AP01 is currently in an open-label extension of the Phase Ib trial in IPF patients, whilst AP02 has been evaluated in a Phase I study with healthy volunteers.

With a limited number of approved drugs for IPF in the market, Esbriet and Ofev dominate the sales in the field. Esbriet generated SFr119m ($129.5m) in sales in H1 2023, as per Roche’s financials.

However, there are more than 300 drugs currently in development to treat IPF, with 30% of these drugs currently in clinical development (Phase I or later), as per GlobalData.

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Other drugs currently in development for IPF include Redx Pharma’s zelasudil (RXC007), which was granted orphan drug designation by the US Food and Drug Administration (FDA) based on Phase II data. United Therapeutic’s Tyvaso (treprostinil) is also being studied in two Phase III trials (NCT04708782 and NCT04905693).