– The IMPROVE-ISCHEMIA Phase 2 medical trial met the first endpoint of tolerability and security; 8-weeks therapy with ninerafaxstat additionally demonstrated a statistically important enchancment in dobutamine stress-induced ischemic left ventricular (LV) dysfunction in comparison with placebo, in addition to a rise in myocardial glucose utilization, confirming goal engagement –
– Results affirm the direct anti-ischemic impact of ninerafaxstat and help additional growth in cardiac ischemic problems together with secure angina –
BOSTON, Nov. 12, 2023 (GLOBE NEWSWIRE) — Imbria Pharmaceuticals, Inc., a medical stage, cardiometabolic firm devoted to creating revolutionary therapies designed to enhance affected person signs and performance by enhancing mobile energetics, right this moment introduced optimistic topline outcomes from the randomized, double-blind, placebo-controlled Phase 2 IMPROVE-ISCHEMIA trial, evaluating ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation (pFOX) inhibitor, in sufferers with power secure angina.
Treatment with ninerafaxstat was properly tolerated and no security alerts have been noticed.
At 8-weeks, therapy with ninerafaxstat demonstrated clinically and statistically important enhancements in dobutamine stress-induced ischemic left ventricular (LV) wall movement abnormalities. This strong anti-ischemic impact was not depending on modifications in myocardial blood circulate, in step with a direct, metabolic mechanism of motion of ninerafaxstat focusing on the cardiomyocyte. In addition, a big improve in myocardial glucose utilization in comparison with placebo was noticed, confirming the flexibility of ninerafaxstat to induce a change in substrate use to glucose, the optimum power supply within the setting of ischemia.
“The randomized, placebo-controlled IMPROVE-ISCHEMIA trial provides detailed insights into the anti-ischemic effects of ninerafaxstat in symptomatic patients with stable angina,” said Juhani Knuuti, M.D., Ph.D., Professor and Director of Turku PET Centre in Turku, Finland and chief investigator of the IMPROVE-ISCHEMIA trial. “Given the large projected future increases in the incidence of ischemic heart disease and the limited level of therapeutic innovation, there is a pressing need to address the high symptomatic burden of angina with novel effective oral therapies.”
“These topline results from IMPROVE-ISCHEMIA confirm the anti-ischemic effect of ninerafaxstat and support further development in cardiac ischemic disorders,” stated Jai Patel, MRCP (U.Ok.), chief medical officer of Imbria. “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.”
Imbria anticipates sharing full knowledge from the IMPROVE-ISCHEMIA Phase 2 medical trial at an upcoming medical convention.
About IMPROVE-ISCHEMIA
IMPROVE-ISCHEMIA (NCT04826172) is a randomized, double-blind, placebo-controlled medical trial evaluating the protection, tolerability of ninerafaxstat in sufferers with secure angina and power coronary syndrome handled for 8-weeks on prime of present antianginals. The trial additional evaluated the anti-ischemic results of ninerafaxstat by means of evaluation of myocardial blood circulate and myocardial purposeful response to ischemia utilizing dobutamine stress echocardiography.
About Stable Angina
In the U.S. alone, the general prevalence of secure angina is estimated at roughly 4% of all adults (>10 million, Tsao et al., Circulation 2023) with 500,000 new instances of angina occurring yearly. Stable angina is characterised by recurrent episodes of reversible cardiac oxygen demand/provide mismatch usually leading to ache or heaviness within the anterior chest and could also be accompanied by fatigue leading to poor high quality of life.
Although cardiac ischemia is a metabolic dysfunction disrupting mobile energetics, there are presently no authorised pharmacological therapies within the U.S. which instantly deal with this by focusing on cardiomyocyte metabolism. Pharmacological therapy of angina has historically centered on manipulating hemodynamics to cut back cardiac oxygen demand by reducing blood stress, cardiac contractility, and/or coronary heart price utilizing beta blockers, calcium channel antagonists, and nitrates ceaselessly together. However, when titrated to impact, these brokers usually attain a plateau of hemodynamic suppression, the place including additional dose increments or therapies with the same hemodynamic mechanism of motion confers little additive symptomatic profit, whereas opposed results improve, which can restrict tolerability and stop sufficient symptom reduction.
About ninerafaxstat
Our lead product candidate, ninerafaxstat, is an revolutionary therapy for cardiac illnesses characterised by an imbalance of power provide and demand within the coronary heart. To preserve regular pump operate and cell viability, the center requires substantial quantities of power, which is produced within the type of ATP. The coronary heart usually makes use of two main fuels for power technology: fatty acids and glucose. Ninerafaxstat, a partial fatty acid oxidation (pFOX) inhibitor, acts to shift the center’s choice from fatty acids in the direction of glucose. This shift in metabolism results in extra environment friendly power technology with the potential for improved cardiac operate each at relaxation and through train.
About Imbria
Imbria is a privately held, medical stage firm creating novel therapies for sufferers with life-altering cardiometabolic problems. Our medical stage pipeline is concentrated on restoring or enhancing the cell’s capability to supply power in cardiovascular problems the place energetic impairment is a elementary contributor to signs and purposeful deficits. The lead product candidate, ninerafaxstat, is presently in Phase 2 medical growth in three indications: non obstructive cardiomyopathy (nHCM), secure angina, and coronary heart failure with preserved ejection fraction (HFpEF). For extra data, please go to www.imbria.com.
Contact:
Komal Joshi
Imbria Pharmaceuticals, Inc.
[email protected]
