-Corventum, Inc., a new medicines company advancing novel therapies to make existing cancer treatments safer and more effective,  announced the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for CVT-130 for the prevention of anthracycline-related cardiotoxicity. CVT-130 is a first-in-class metabolic modulator being developed to protect against chemotherapy-induced cardiac injury and to address additional diseases involving mitochondrial dysfunction. The company plans to initiate a first-in-human Phase 1 clinical trial in the second quarter of 2026.

“Anthracyclines have saved countless lives, yet the use of these highly effective chemotherapies is limited by cumulative heart damage that can appear months or years after treatment,” said Randall Peterson, Ph.D., Corventum co-founder, CVT-130 co-inventor, and Dean of the University of Utah College of Pharmacy. “CVT-130 was designed to protect cardiac cells from damage caused by anthracyclines, potentially allowing more patients to benefit from these widely used cancer treatments and enabling retreatment in recurrent disease.”

“Our preclinical data show that CVT-130 prevents cardiac injury while maintaining full anti-tumor potency, a balance that no therapy has achieved to date,” said Aarti Asnani, M.D., Corventum co-founder, CVT-130 co-inventor, and Chair of the Cardio-Oncology Committee of the American Heart Association. “With FDA clearance of the IND, we can now advance CVT-130 to the clinic and take the next step toward delivering a therapy that could benefit millions of patients worldwide who depend on anthracyclines for cancer treatment.”

The planned randomized, placebo-controlled Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CVT-130 in healthy volunteers, along with cardiac and mitochondrial biomarkers. The study is designed to identify an optimal dose for a subsequent Phase 2 trial in cancer patients. Corventum worked closely with the FDA to align on the Phase 1 study design, which reflects the intended dosing strategy for the Phase 2 clinical trial.