Atrium Therapeutics, Inc.NASDAQ: RNA

Atrium Therapeutics Announces FDA Clearance of Investigational New Drug Application for ATR 1072 for Treatment of PRKAG2 Syndrome

· Issued by Atrium Therapeutics, Inc. via PR Newswire

-- ATR 1072 is the company's first precision cardiology program to enter the clinic --

-- Corventis™ will be the first clinical trial for people living with PRKAG2 syndrome that evaluates a potential treatment for the underlying cause of the disease --

SAN DIEGO, July 14, 2026 /PRNewswire/ -- Atrium Therapeutics, Inc. (Nasdaq: RNA) (the "Company"), a biopharmaceutical company dedicated to delivering RNA therapeutics to the heart, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application allowing the Company to move forward with its Corventis™ Phase 1/2 clinical trial designed to evaluate ATR 1072 for the treatment of Protein Kinase AMP-activated non-catalytic subunit Gamma 2 (PRKAG2) syndrome.

"PRKAG2 syndrome and other rare genetic cardiomyopathies represent a profound unmet need — these are progressive, life-altering and life-threatening diseases that often strike early, affect multiple members of the same family, and have no approved therapy to address their root cause," said Kathleen Gallagher, President and Chief Executive Officer, Atrium Therapeutics. "FDA clearance of our IND and the launch of the Corventis™ Phase 1/2 trial reinforce our team's ability to move with speed on behalf of patients with the goal of delivering potential disease-modifying treatments."

Corventis™ is a Phase 1/2 open-label, multicenter clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ATR 1072. The study will enroll approximately 37 participants across two parts: Part A, multiple ascending dose cohorts to characterize safety and support dose selection, and Part B, a single-arm expansion cohort at the recommended Phase 2 dose to further evaluate safety and efficacy trends in cardiac structure and function.

Clinical site initiation activities are currently underway, and Atrium expects the first participant to be enrolled by the end of 2026. Initial trial data demonstrating proof of concept is anticipated in the second half of 2027.

About ATR 1072

ATR 1072, the company's lead product candidate, is a potentially disease-modifying treatment for PRKAG2 syndrome. Using Atrium's precision RNA delivery technology, ATR 1072 uses small interfering RNA (siRNA) to silence mutant PRKAG2 messenger RNA (mRNA), normalize AMP-activated protein kinase (AMPK) activity and reduce pathogenic glycogen accumulation, potentially leading to improved heart function.

About PRKAG2 Syndrome

Company analysis

Earlier from Atrium Therapeutics

All Atrium Therapeutics news releases