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Avalyn is developing inhaled approaches to treat people with severe respiratory disease

Avalyn is a biopharma company committed to developing improved therapies for the treatment of idiopathic pulmonary fibrosis (IPF) and other severe respiratory diseases. Our lead asset is inhaled pirfenidone (AP01) for the treatment of IPF. With offices in Seattle and San Diego, Avalyn's experienced clinical and inhaled product development team is rapidly advancing AP01 for the treatment of IPF and additional pipeline candidates for IPF and other severe respiratory diseases.

Corporate Fact Sheet

Therapeutic Focus

Although two products are available to treat IPF, a substantial unmet need remains for highly tolerable medicines enabling improved effect stand-alone and add-on combination therapy.

Similar to a scar obtained from an injury to the skin, pulmonary fibrosis (PF) is a scar that forms in the lungs. However, pulmonary fibrosis has much more serious consequences than a simple scar. In PF, scar tissue builds up in the scaffolding of the lungs and makes it difficult for inhaled oxygen to enter the blood. Low oxygen levels and lung stiffness from the formed scar cause a person to feel short of breath reducing their ability to exercise or perform normal daily activities. Idiopathic pulmonary fibrosis (IPF) is severe form of PF, where in the absence of lung transplant, the majority of patients only survive 2-5 years. Comparatively, IPF causes more deaths per year than breast cancer and only lung cancer has a worse prognosis. IPF primarily affects people over the age of 50 and is more common in men than women.

With about 46,000 people diagnosed each year and between 120,000 and 150,000 living in each region, IPF is recognized as an orphan indication by both US and European regulatory agencies.

IPF treatments are relatively new, with the first and only approvals coming in 2014; oral pirfenidone (Esbriet®) and oral nintedanib (Ofev®). Each medicine, while effective, is 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, a substantial unmet need remains for highly tolerable medicines enabling improved effects as stand-alone and add-on combination therapies.

The Inhaled Advantage

Small inhaled doses deliver highly-effective lung levels while avoiding side effects associated with large oral doses.

Pirfenidone is a low potency drug that requires a very large oral dose to deliver highly-effective lung levels. Unfortunately, blood level safety limits and poor compliance due to oral dose related adverse effects reduce the oral product's benefit. To maximize pirfenidone's potential, Avalyn has reformulated pirfenidone for nebulization and inhaled aerosol lung delivery. By this approach, small inhaled doses delivered directly to the lung hold promise to maximize pirfenidone's effect while avoiding adverse effects associated with oral delivery.

Our data indicates that as stand-alone therapy, inhalation may substantially-reduce or eliminate oral adverse effects and potentially increase pirfenidone's efficacy through a greater lung dose and improved compliance. Moreover, as a safe and well-tolerated therapy, inhalation may enable pirfenidone's use in otherwise poorly-tolerated, add-on combination regimens.