Avalyn Pharma develops inhaled formulations of anti‑fibrotic drugs, such as pirfenidone (AP01), delivered via a handheld eFlow® nebulizer that targets the lung directly. This lung‑focused delivery enables lower systemic doses, reducing side effects and improving patient adherence while aiming to stabilize lung function in progressive interstitial lung diseases.
Funding
$100M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
1OSCFounders
Product
Problem
Patients with rare interstitial lung diseases such as pulmonary fibrosis have limited treatment options. Existing oral therapies provide modest disease‑modifying effects but cause systemic side effects that reduce adherence and overall effectiveness.
Solution
Avalyn Pharma develops inhaled formulations of proven anti‑fibrotic agents, delivering the drug directly to diseased lung tissue via a handheld eFlow® nebulizer. By aerosolizing pirfenidone (AP01) as a soft‑mist, the approach achieves therapeutic concentrations in the lung while using lower systemic doses, which can lessen adverse events. Clinical data from the Phase 1b ATLAS study showed near‑stabilization of lung function over 48 weeks with a favorable safety profile compared with oral pirfenidone. The company is currently enrolling a Phase 2b MIST study to confirm efficacy and safety in patients with progressive pulmonary fibrosis. This inhaled delivery platform aims to improve patient persistence, reduce systemic toxicity, and potentially enhance disease‑modifying outcomes.
Target Audience
Primary customers are pulmonologists and specialty respiratory clinics treating patients with idiopathic pulmonary fibrosis and other progressive interstitial lung diseases who require disease‑modifying therapy with improved tolerability.
Features
- Inhaled pirfenidone formulation (AP01) delivered via FDA‑cleared eFlow® handheld nebulizer producing a soft‑mist aerosol
- Lung‑targeted drug deposition enables lower total dose while maintaining therapeutic exposure to fibrotic tissue
- Reduced systemic exposure minimizes common oral pirfenidone adverse events such as gastrointestinal upset and photosensitivity
- Phase 1b ATLAS trial demonstrated near‑stabilization of forced vital capacity over 48 weeks with good tolerability
- Ongoing Phase 2b MIST study evaluating efficacy and safety in progressive pulmonary fibrosis (US sites)
- Platform adaptable to other small‑molecule anti‑fibrotic agents for broader interstitial lung disease indications