Fraunhofer Institute for Toxicology and Experimental Medicine
Idiopathic pulmonary fibrosis (IPF) is a severe and progressive lung disease with no known cause and no cure. Patient survival after diagnosis is only 2-5 years. Available treatments, such as anti-fibrotics, slow disease progression but do not regenerate the lung.
CMR316 is a first-in-class drug designed to target and stimulate type 2 alveolar epithelial cells (AEC2s) in the lung alveoli that are reduced in patients with IPF. Stimulating AEC2 stem cells promotes their differentiation from type 1 AEC cells, which are essential for gas exchange and maintaining lung stability and function. CMR316 is an inhaled, lung-targeted drug administered once weekly, designed to precisely expand lung stem cells and regenerate damaged lung tissue.
Researchers of Fraunhofer ITEM are conducting the first-in-human clinical trial to assess the safety, tolerability, and pharmacokinetics of single and multiple inhaled doses of CMR316. This three-part, single-center study investigates single ascending doses (part 1) and multiple ascending doses (once-weekly dosing for 4 weeks — part 2) of nebulized CMR316 or placebo in healthy participants. Part 3 will assess multiple doses (once weekly for 4 weeks) in IPF patients. This clinical trial includes bronchoscopies to evaluate lung pharmacokinetics in subgroups.
