USFDAJul 14, 2026, 05:21 PM
Atrium Therapeutics gets FDA IND clearance for ATR 1072 Phase 1/2 trial
AI Summary
Atrium Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATR 1072. This clearance enables the company to advance to its Corventis™ Phase 1/2 clinical trial, which aims to evaluate ATR 1072 for the treatment of Protein Kinase AMP-activated non-catalytic subunit Gamma 2 (PRKAG2) syndrome. This marks the company's first precision cardiology program to enter clinical development, addressing a significant unmet medical need for this rare genetic cardiomyopathy.
Key Highlights
- FDA cleared Investigational New Drug (IND) application for ATR 1072.
- Allows Atrium Therapeutics to proceed with Corventis™ Phase 1/2 clinical trial.
- ATR 1072 is designed to treat PRKAG2 syndrome, a rare cardiomyopathy.
- The trial will enroll approximately 37 participants.
- First participant enrollment is expected by the end of 2026.
- Initial proof-of-concept data is anticipated in the second half of 2027.
- ATR 1072 is the company's first precision cardiology program to enter the clinic.
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