Atrium Therapeutics Receives FDA Clearance for ATR 1072 Clinical Trial for PRKAG2 Syndrome

Atrium Therapeutics announced July 15, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATR 1072. This clearance allows the company to initiate the Corventis™ Phase 1/2 clinical trial to evaluate the drug candidate for the treatment of Protein Kinase AMP-activated non-catalytic subunit Gamma 2 (PRKAG2) syndrome.

PRKAG2 syndrome is a rare genetic cardiomyopathy with no approved therapy, characterized by heart muscle thickening and arrhythmias due to mutations in the PRKAG2 gene. Atrium Therapeutics CEO Kathleen Gallagher stated that the condition "represent[s] a profound unmet need." The Corventis™ trial marks the first clinical study for PRKAG2 syndrome designed to target the underlying cause of the disease.

The Corventis™ trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ATR 1072. Approximately 37 participants will be enrolled in two parts: dose escalation and an expansion cohort. The company expects to enroll the first participant by the end of 2026, with initial proof-of-concept data anticipated in the second half of 2027.

ATR 1072 is Atrium's lead product candidate, utilizing its RNA delivery technology to silence mutant PRKAG2 messenger RNA (mRNA) and reduce pathological glycogen accumulation in the heart, aiming to improve cardiac function. The company also has other candidates in development for rare cardiomyopathies.