Imbria hits safety benchmark in phase 2 heart failure test as early efficacy data buoy late-stage plans

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来源: FierceBiotech

Imbria Pharmaceuticals is now eyeing a phase 3 study to further test the efficacy of ninerafaxstat and plans to meet with regulatory authorities soon to discuss the trial design.

Imbria Pharmaceuticals’ heart failure medicine met the safety and tolerability goals in a phase 2 trial while also improving results on a cardiopulmonary exercise test, with patients reporting other improvements in their conditions as well.

The Boston-based biotech said Tuesday that ninerafaxstat is the first drug to show an improvement in a functional measurement of symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM), an inherited heart disease.

In the phase 2 IMPROVE-HCM trial, Imbira was testing the safety and tolerability of the partial fatty acid oxidation inhibitorfatty acid oxidation inhibitor, which aims to shift the heart’s preference from fatty acid toward glucose. The hope is that this metabolism shift will lead to more efficient energy generation and improve cardiac function. NHCM causes abnormal thickening of the heart muscle leading to complications include a deficiency in cardiac energy and inefficient energy utilization.

After 12 weeks of treatment, patients receiving ninerafaxstat had a statistically significant improvement in a functional cardiopulmonary exercise test, which was associated with clinically relevant improvement in patient-reported outcomes, Imbria said.

Ninerafaxstat was well tolerated, and there were no safety signals observed. More data from the IMPROVE-HCM trial will be revealed at a future medical meeting.

Imbria is now eyeing a phase 3 study to further test the efficacy of ninerafaxstat. The company will meet with regulatory authorities soon to discuss the trial design.

With the results suggesting the med can have an impact on cardiac energy deficiency, Imbria thinks ninerafaxstat could have a wider impact in other cardiac diseases including heart failure with preserved ejection fraction (HFpEF), said CEO Anne Prener, M.D., Ph.D.

Ninerafaxstat is Imbria’s only pipeline med. The biotech has a three-pronged clinical approach testing the med in nHCM, HFpEF and obstructive coronary arterial disease.

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