Piramal Receives IND Approval for Novel DGAT1 Inhibitor

Piramal Enterprises Limited recently announced it has 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 increased lipid levels (including triglycerides) is one of the major risk factors for cardiovascular disease (CVD). It has been reported by the World Health Organization that CVD is the number one cause of deaths globally, representing approximately 30% of all deaths. Currently, there is a significant 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 showing significant reduction in triglyceride levels, glucose and insulin levels, and decrease in food intake and body weight gain – factors associated with lipid abnormalities and metabolic disorders. PEL has established the safety and tolerability of P7435 in a Phase 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.

“The NCE Research division of PEL continues its ambitious diabetes/metabolic disorders program to discover and develop NCEs to fight against diseases like diabetes and lipid disorders,” said Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises Limited. “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.”

The NCE Research division of Piramal Enterprises Limited focuses on the discovery and development of innovative small molecule medicines to improve the lives of patients suffering from cancer, metabolic disorders, and inflammatory conditions. The key elements of our strategy include capitalizing on Piramal’s strengths, in particular the India advantage, and leveraging external partnerships to achieve high levels of R&D productivity. Piramal’s state-of-the-art Research Centre in Mumbai has comprehensive capabilities spanning target identification all the way through clinical development. Its robust pipeline, including 8 compounds in clinical development, bears testimony to its innovative and rigorous drug discovery process. For more information, visit www.piramalenterprises.com/NCE.

Piramal Enterprises is one of India’s largest diversified companies, with a presence in pharmaceutical, financial services, and information management sectors. Piramal Enterprises had consolidated revenues of over $ 650 million in FY2013. For more information, visit www.piramal.com.