FDA Greenlights Atrium Therapeutics’ ($RNA) Corventis™ Trial

Atrium Therapeutics, Inc. (NASDAQ: RNA) has received approval from the U.S. Food and Drug Administration for its Investigational New Drug application, allowing the company to initiate its Corventis™ Phase 1/2 clinical trial.

This trial will assess ATR 1072, a treatment for Protein Kinase AMP-activated non-catalytic subunit Gamma 2 (PRKAG2) syndrome.

The Corventis™ trial is an open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ATR 1072.

It will enroll approximately 37 participants in two parts: Part A will involve multiple ascending dose cohorts to determine safety and support dose selection, while Part B will focus on a single-arm expansion cohort at the recommended Phase 2 dose to further assess safety and efficacy trends in cardiac structure and function.

ATR 1072, Atrium’s lead product candidate, is a potentially disease-modifying treatment for PRKAG2 syndrome.

Utilizing Atrium’s precision RNA delivery technology, ATR 1072 employs small interfering RNA to silence mutant PRKAG2 messenger RNA, normalize AMP-activated protein kinase activity, and reduce pathogenic glycogen accumulation, potentially improving heart function.

“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.

Shares of Atrium Therapeutics, Inc. (NASDAQ: RNA) are up 1.47 percent in pre-market trading, reaching a price of $12.40. This represents an increase of $0.18 from the previous close of $12.22. The stock’s 52-week trading range stands between $11.40 and $16.77.