Indalo Therapeutics Initiates Phase 1 Trial of Antifibrotic Drug Candidate IDL-2965

Indalo Therapeutics announced the first healthy volunteer has been dosed in a Phase 1 clinical trial of the company's lead drug candidate IDL-2965.

"IDL-2965 reflects true scientific innovation in the biology of treating fibrosis, an area with significant unmet medical need," said Chief Medical Officer Bill Bradford, M.D., Ph.D. "Despite recent medical advances, median survival for patients diagnosed with IPF is still worse than many cancers, while NASH is rapidly becoming one of the most devastating epidemics of our time."

IDL-2965 is an oral, selective antagonist of αvβ1, αvβ3, and αvβ6 that uniquely inhibits multiple fibrogenic processes, including the local activation of TGF-β (a central regulator of pathologic fibrosis) as well as the ability of stiff extracellular matrix to promote fibroblast migration and survival. Preclinically, IDL-2965 displays potent antifibrotic efficacy at low once-daily oral doses across multiple models of disease in vital organ systems, including the liver, lung, and kidney.

IDL-2965 is being tested in an adaptive Phase 1/2a clinical trial program designed to progress rapidly from assessment of safety and pharmacokinetics (PK) in healthy volunteers to measurement of markers of target activation and disease in patients. The objective of the program is to provide a robust package of data to enable decision making and design for late-stage development in one or more indications as early as next year.

"With the initiation of this study, IDL-2965 becomes one of very few direct antifibrotic drugs in clinical development for NASH and IPF, our initial target indications," said President and Chief Executive Officer Robert Jacks. "We are now laser-focused on advancing IDL-2965 rapidly into clinical evaluation in multiple patient populations to demonstrate the potential of our unique approach to treating fibrosis."

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