Avalyn initiates Phase 1b study of APO2 inhaled nintedanib

Avalyn Pharma has initiated a Phase 1b SAD/MAD trial of its AP02 inhaled nintedanib delivered via the PARI eFlow nebulizer in healthy adults, the company said. Avalyn is developing AP02, along with AP01 inhaled pirfenidone, for the treatment of pulmonary fibrosis. In September 2023, the company announced that it had raised $175 million for continued development of AP01 and AP02.

Avalyn CEO Lyn Baranowski commented, “The initiation of this AP02 study marks an important milestone for Avalyn, bringing us closer to delivering a potential new inhaled therapy to patients with pulmonary fibrosis who are in urgent need of safe and effective treatments that they can tolerate for long-term management of their disease. We’re excited to build on our completed Phase 1a study of AP02 and assess its pharmacokinetic profile to inform our future clinical studies. Our team has deep expertise in the development of inhaled therapies, and we’re intensely committed to advancing potentially transformational medicines for patients with life-threatening pulmonary diseases.”

Read the Avalyn Pharma press release.

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