Atrium Therapeutics Says FDA Clears Phase 1/2 Trial of ATR 1072 in PRKAG2 Syndrome
Atrium Therapeutics (RNA) said Tuesday the US Food and Drug Administration cleared its investigational new drug application for its lead product candidate ATR 1072, allowing the company to advance a phase 1/2 clinical trial in people living with protein kinase AMP-activated non-catalytic subunit gamma 2, or PRKAG2, syndrome. The company said the trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of ATR 1072, its first precision cardiology program to enter clinical development. Atrium said it expects to enroll about 37 participants, with the first participant anticipated to enter the program by the end of 2026. Initial proof-of-concept data anticipated in H2 of 2027, the company said. Shares of Atrium Therapeutics were up 1.5% in premarket activity Tuesday.
Atrium Therapeutics (RNA) said Tuesday the US Food and Drug Administration cleared its investigational new drug application for its lead product candidate ATR 1072, allowing the company to advance a phase 1/2 clinical trial in people living with protein kinase AMP-activated non-catalytic subunit gamma 2, or PRKAG2, syndrome.
The company said the trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of ATR 1072, its first precision cardiology program to enter clinical development.
Atrium said it expects to enroll about 37 participants, with the first participant anticipated to enter the program by the end of 2026.
Initial proof-of-concept data anticipated in H2 of 2027, the company said.
Shares of Atrium Therapeutics were up 1.5% in premarket activity Tuesday.