Avalyn raises $175m in funding to develop inhaled IPF drugs

临床1期临床2期临床3期孤儿药临床结果
Phalguni Deswal
@Phalguni_GD
With a limited number of approved drugs for IPF in the market, Esbriet and Ofev dominate the sales in the field. Image Credit: eamesBot / Shutterstock.
Avalyn Pharma secured $175m in a Series C financing round to fund the clinical development of inhaled pulmonary therapies.
The US-based company plans to advance idiopaIPFc pulmonary fibrEsbrietPF) tOfevpies, AP01 (inhaled pirfenidone) and AP02 (inhaled nintedanib), to Phase IIb and IIa trials, respectively.
Avalyn Pharma drugs—Roche’s Esbriet/Pirespa (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib)—are commonly used to reduce scarring. Avalyn is developing inhaled formulations in an effort to reduce the systemic side effects of the drugs. Avalyn CEO Lyn Baranowski highlighted the need for an alternate mode of administration stating: “Fewer than 30% of patients in the US are treated with either of the two approved oral medicines today due to their significant tolerability challenges.”
AP01 is currently in an open-label extidiopathic pulmonary fibrosisinIPFF patients, wAP01t AP02 haspirfenidoneated iAP02Phase I stnintedanibealthy volunteers.
With a limited numbeRocheappEsbrietrPirespa Ipirfenidonearket,Boehringer IngelheimminOfevthe sales in the field. Esbriet generated scarring($Avalyn) in sales in H1 2023, as per Roche’s financials.Avalyn
AP01ver, there are more than 300 drugs currently in development to treIPFIPF, with 30% of tAP02 drugs currently in clinical development (Phase I or later), as per GlobalData.
GlobalData is the parent company of PharmaceIPFcal Technology.EsbrietOfevEsbrietRoche
Other drugs currently in development for IPF include Redx Pharma’s zelasuIPF (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).
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