Company Watch

PLSL kicks off phase I trial for diabetes metabolic syndrome in Canada

Our News Bureau - Mumbai

Piramal Life Sciences (PLSL) has commenced phase I trial of a new experimental drug molecule P2202 for diabetes-metabolic syndrome in Canada. P2202 is the second compound from Eli Lilly and is part of the collaborative agreement between the two companies and is being developed for diabetes-metabolic syndrome.

The metabolic syndrome is characterised by a group of metabolic risk factors such as abdominal obesity, blood fat disorders (high triglycerides, low HDL cholesterol and high LDL cholesterol) that foster plaque build-ups in artery walls, elevated blood pressure, insulin resistance or glucose intolerance, prothrombotic state, and proinflammatory state. People with the metabolic syndrome are at increased risk of coronary heart disease, stroke, peripheral vascular disease, and type II diabetes.

P2202 is being developed for the treatment of metabolic disorders. It has been shown to lower glucose levels, triglycerides, and total cholesterol in animals and decrease plaque area in the animals having atherosclerosis. A phase I study of P2202 in healthy volunteers has been initiated to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug.

Dr Swati Piramal, Director, Piramal Group, said, "We are dedicated to finding new cures for metabolic disorders. Propelled by our core values of Knowledge, Action and Care, Piramal Life Sciences focuses upon nurturing innovation and breakthrough thinking to impact the lives of millions. Within dynamic, nimble-footed delivery we strive to make quality drugs accessible. We are happy and proud that our world-class dossier for P2202 has been accepted by the Canadian regulatory authorities, and we were able to obtain approval within 30 days to initiate this phase I clinical trial."

The company had submitted the Clinical Trial Application (CTA) for P2202 to Health Canada, Canada's regulatory authority. This body has approved the company's application to initiate the phase I study of P2202.

Dr Somesh Sharma, Managing Director, PLSL stated, "This is our eighth entity to enter the clinic and third for diabetes-metabolic disorders and bears testimony to our efforts to build a diversified and strong pipeline of products to address unmet medical needs in this important therapeutic segment."