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Piramal Enterprises Ltd (PEL) announced on Tuesday that it received approval from the USFDA for its Investigational New Drug (IND) P7435. This is a novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor. P7435 has been developed by the NCE Research Division of PEL for the management of metabolic disorders such as lipid abnormalitiesand diabetes. It is well-established that increasedlipid levels’ (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD). It has been reported by the World Health Organisation, that CVD, is the number one cause of deaths globally, representing approximately 30% of all deaths. Currently, there is asignificant medical need for effective and safe drugs for the management of lipid abnormalities and metabolic disorders.
P7435 has demonstrated its lipid lowering potential in various preclinical studies by showingsignificant reduction in triglyceride levels, glucose and insulin levels,and decrease in food intake and body weight gain -factorswhich areassociatedwith lipid abnormalities and metabolic disorders.
PEL has established the safety and tolerability of P7435 in aPhase I trial recently completed in India. This extension trial in the US will further evaluate the safety and efficacy of P7435 in a larger population.
Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises Limited said, “The NCE Research division of PEL continues its ambitious diabetes/metabolic disorders programme 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 drugand will provide therapeutic solutions not just to India but also to the rest of the world.”