Piramal Enterprises Ltd. has received approval from the FDA for its IND for P7435, a novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor for treatment of lipid disorders and diabetes.
P7435 has demonstrated its lipid lowering potential in various preclinical studies, showing a reduction in triglyceride levels, glucose and insulin levels, and decrease in food intake and body weight gain. Piramal has established the safety and tolerability of P7435 in a Phase I trial recently completed in India. This extension trial in the U.S. will further evaluate the safety and efficacy of P7435 in a larger population.
Dr. Swati Piramal, vice chairperson of Piramal, said, “The NCE Research division of Piramal continues its ambitious diabetes/metabolic disorders program to discover and develop NCEs to fight against diseases like diabetes and lipid disorders. With P7435 we are looking at addressing a serious need for effective and well-tolerated drugs that treat lipid disorders, which are commonly associated with diabetes and CVDs. Expansion of this trial will allow testing this NCE in a wider population, which is critical to the development of this drug and will provide therapeutic solutions not just to India but also to the rest of the world.”