Avalyn Secures $100M for Inhaled Lung Disease Meds

Avalyn Pharma is advancing its innovative approach to treating lung conditions by developing novel inhaled formulations of existing drugs. Recently, the company secured $100 million in funding, which will be used to speed up the development of these inhaled therapies for pulmonary fibrosis, a serious lung condition characterized by scarring of lung tissue, which makes breathing increasingly difficult.

The latest round of funding, described as a Series D raise, was led by Suvretta Capital Management and SR One, with participation from 16 other investors, including Novo Holdings, known for its significant stake in Novo Nordisk. Avalyn Pharma, based in Cambridge, Massachusetts, focuses on creating inhaled versions of two approved drugs and aims to reduce the systemic side effects by delivering medication directly to the lungs.

One of Avalyn Pharma’s primary projects is an inhaled formulation of pirfenidone, originally marketed in pill form under various names, including Pirespa, for the treatment of idiopathic pulmonary fibrosis (IPF). This inhaled version, called AP01, is currently being tested in a global phase 2b clinical trial known as Mist. This study is anticipated to enroll 300 participants, with its primary results expected to be available by April of the following year, according to data from ClinicalTrials.gov. The company has reported that during an ongoing open-label extension of a phase 1b trial, the inhaled drug has demonstrated both safety and efficacy over a period exceeding four years.

In addition to AP01, Avalyn’s other flagship program involves the inhaled reformulation of nintedanib, an oral medication marketed as Ofev and Vargatef for IPF. The inhaled version, named AP02, is poised to begin phase 2 trials for IPF shortly.

Lyn Baranowski, CEO of Avalyn Pharma, acknowledged the challenging market environment and expressed that the successful financing round underscores the innovative methods the company employs in developing potentially life-saving treatments for patients with pulmonary fibrosis. This recent financial boost follows Avalyn’s previous successful funding rounds, including a $175 million Series C in 2023 and a $35.5 million Series B in 2020.

Avalyn’s strategy focuses on creating inhaled drug formulations to target the disease site directly, thereby minimizing the drug's systemic exposure. This approach is particularly beneficial for conditions like pulmonary fibrosis, where current treatments often come with significant side effects due to systemic absorption.

Beyond its existing projects, Avalyn Pharma is also working on developing AP03, a next-generation inhaled fixed-dose combination of AP01 and AP02. This is a significant advancement, as combining the two oral therapies has previously been unfeasible due to their cumulative side effects. Avalyn is conducting preclinical studies for this new combination therapy, signaling continuous progress in their research and development efforts.

Through these initiatives, Avalyn Pharma is making strides in the treatment of lung diseases by innovating drug delivery methods that aim to improve patient safety and treatment efficacy. The company’s focus on inhalation delivery systems reflects a broader trend in pharmaceutical development, aiming to enhance the quality of life for patients with chronic and progressive lung conditions.