AC01 demonstrated a favorable safety and tolerability profile and exploratory efficacy assessments showed encouraging, consistent signals of rapid and sustained improvements in hemodynamics, and cardiac structure and function over 28 days of treatment, describes the company. These findings clearly justify advancing AC01 into a Phase 2b study and reinforce the company’s confidence in its continued clinical development, the company states.

The Phase 2a part of GOAL-HF1 enrolled 26 patients across 13 European heart failure centers, randomized to receive 1 mg or 3 mg AC01, or placebo twice daily for 28 days.

“These Phase 2a results strengthen our conviction in AC01’s potential to transform the treatment landscape for heart failure. The consistency across safety, tolerability, and markers of cardiac function improvements gives us strong confidence to rapidly progress AC01 into late-stage development. We believe AC01 is emerging as a highly differentiated, first-in-class therapy with the potential to deliver meaningful improvements in cardiac function for patients who need better treatment options,” says Patrik Strömberg, CEO of AnaCardio.