Avalyn Pharma Reports Update in Ongoing Idiopathic Pulmonary Fibrosis Trial

October 20, 2021 06:00 AM Eastern Daylight Time

SEATTLE--(BUSINESS WIRE)--Avalyn Pharma Inc., a biopharmaceutical company focused on development of improved therapies for life threatening pulmonary diseases, announced today that Marc Schneebaum has joined the company as Chief Financial Officer.

“I am pleased to welcome Marc to Avalyn as our Chief Financial Officer,” said Dr. A. Bruce Montgomery, CEO of Avalyn. “We are preparing to advance our lead drug candidate, inhaled pirfenidone (AP01), into Phase 3 studies, with important implications for the Company’s growth and its strategic and operational needs. Marc’s broad experience in biopharma and other life science organizations, will be quite valuable as we transition to the later stages of development. His specific skills in financing and financial strategy, corporate strategy and business development will be particularly important.”

Most recently, Mr. Schneebaum was Senior Vice President and Chief Financial Officer of Madrigal Pharmaceuticals, Inc., where he leveraged Madrigal’s $60 million in liquidity sources as a new public company and thereafter financed over $600 million in equity capital in support of the company’s Phase 2 and Phase 3 clinical studies and corporate growth. Prior to Madrigal, Marc was Senior Vice President and Chief Financial Officer of Synta Pharmaceuticals, Inc., a company developing oncology drugs; President, Chief Executive Officer and a director of Predictive BioSciences, Inc., a commercial stage oncology diagnostics company; President, Chief Executive Officer, and a director of Sensors for Medicine and Science, Inc., an emerging medical technology company; Senior Vice President, Finance, Business Development and Administration, and Chief Financial Officer of Genetic Therapy, Inc., a biotechnology company (acquired by Sandoz/Novartis). Mr. Schneebaum was a Vice President at Alex. Brown & Sons Incorporated, a leading investment banking firm, where he participated in a variety of finance and strategic assignments, and he began his career in the accounting and auditing group at KPMG LLP, advancing to Senior Manager in the management consulting group. Mr. Schneebaum served as a director of GenVec, Inc., a publicly-held biopharmaceutical company acquired by Intrexon Corporation, from 2007 to 2017, and as a director of several privately-held life science companies. Mr. Schneebaum earned his degree in Business Administration from the University of Maryland.

“Avalyn’s innovative therapeutic for IPF may be a breakthrough for patients with this deadly disease,” said Mr. Schneebaum. “I am excited to join Avalyn at this pivotal juncture in development of its pipeline of therapeutics to treat severe respiratory diseases, and I look forward to working with Bruce and the Avalyn team to contribute to the Company’s growth and success.”

Clinical Need

Idiopathic pulmonary fibrosis (IPF) and other progressive, fibrosing lung diseases (PFILD) are characterized by increasing scarring, decline in lung function, reduced exercise capacity and quality of life, and are associated with early death despite approved therapies. Current treatments are limited to oral pirfenidone (Esbriet®) for IPF and oral nintedanib (Ofev®) for IPF and PFILD. Both medicines, while effective in slowing disease progression, are associated with significant adverse effects that limit dosing and their full potential for efficacy. While these medicines are an important first step to treat IPF and PFILD, a substantial unmet need remains for therapies with improved safety profiles and superior efficacy as either stand-alone or add-on combination.

The Inhaled Advantage

Although oral pirfenidone has shown to slow disease progression in IPF and PFILD, it is a low potency drug requiring a large oral dose to achieve efficacious lung levels. Unfortunately, oral delivery results in first pass metabolism and blood levels which cause substantial adverse effects while providing limited lung dose levels. Avalyn’s AP01, a formulation of pirfenidone optimized for delivery via inhalation, results in approximately 1/15th the systemic exposure of oral pirfenidone, yet it delivers 35-fold higher peak exposure to the affected lung tissue compared to the oral drug. In a recent 91 patient study of two dose regimens of AP01, Avalyn demonstrated the potential of AP01 to improve both efficacy and safety over oral therapy. Specifically, during the first 24 weeks of the study, nausea and rash side effects commonly associated with oral pirfenidone were less frequent with AP01 and a dose response was shown in the change from baseline in forced vital capacity (FVC) with the high dose group, on average, exhibiting stable lung function.

About Avalyn Pharma

More information can be found at www.avalynpharma.com

Contact:

A. Bruce Montgomery, M. D.
CEO Phone: 1-206-707-0340

Seattle office address:

701 Pike Street, Suite 1500
Seattle, WA 98101