Midphase data are arriving thick and fast at Imbria Pharmaceuticals. Days after sharing positive top-line data in one indication, the cardiometabolic biotech has reported a phase 2 trial of the same candidate in a different setting has met its primary endpoint.
Both studies looked at ninerafaxstat, a partial fatty acid oxidation inhibitor that Imbria has identified as a way to enhance cellular energy metabolism and thereby improve outcomes in multiple cardiometabolic diseases. Last week, the biotech chalked up a win in nonobstructive hypertrophic cardiomyopathy, teeing it up to advance into phase 3 in the rare disease indication.
Sunday, Imbria reported its second phase 2 win of the week. The latest top-line success came in a clinical trial that compared ninerafaxstat to placebo in 58 people with chronic stable angina due to obstructive coronary artery disease.
The primary endpoint looked at the incidence and severity of treatment-emergent adverse events from randomization through 10 weeks of follow-up. Imbria cleared the bar for success on the primary goal and shared early evidence of efficacy, linking ninerafaxstat to “clinically and statistically significant improvements in dobutamine stress-induced ischemic left ventricular wall motion abnormalities.”
Imbria added that “this robust anti-ischemic effect was not dependent on changes in myocardial blood flow, consistent with a direct, metabolic mechanism of action of ninerafaxstat targeting the cardiomyocyte.” The biotech also reported a significant increase in myocardial glucose use compared to placebo, a finding that supports the ability of the molecule to induce a switch in substrate use.
In a statement, Chief Medical Officer Jai Patel said the results “confirm the anti-ischemic effect of ninerafaxstat and support further development in cardiac ischemic disorders.”
“This novel approach may have the potential to achieve optimal relief of angina and improve quality of life of patients when used alone or in combination with existing therapies,” Patel added.
Imbria is yet to share numbers to support Patel’s confidence in the program. The biotech plans to present full data from the phase 2 clinical trial at an upcoming event.