Thaindian News

Kolkata, Aug 25 (IBNS) Piramal Life Sciences Limited (PLSL), part of the Piramal Group of companies, today announced the completion of a Phase I study of a new, orally active glucose-lowering compound, P1736, in The Netherlands, and that the drug has an excellent safety profile.

Type 2 Diabetes Mellitus is an emerging worldwide health crisis with an incidence rate of 300 million by 2025 as predicted by the World Health Organization (WHO). Type 2 Diabetes Mellitus (T2DM) or Non-Insulin Dependent Diabetes (NIDDM) accounts for about 90%-95% of the diabetic population. In the US, 20.8 million people, i.e. about 7% of the total population suffers from diabetes. The recent statistics published by the International Diabetes Federation indicates that about 40.9 million people in India suffer from Diabetes and the report suggests that the number will increase to 69.9 million people by 2025.

Type 2 Diabetes Mellitus is the most common form of diabetes marked by insulin secretory dysfunction and peripheral tissue insulin resistance. Diabetic patients have particularly increased cardiovascular mortality due to the attendant risk factors of dyslipidemia, hypertension and obesity. A wide variety of oral drugs are available for use with or without insulin in the management of T2DM. However, most of the currently marketed drugs are associated with adverse events such as weight gain, fluid retention, hepatotoxicity and myocardial infarction.

Some of the adverse effects of this class of drugs are attributed to the peroxisome proliferator activated receptor (PPARγ) activation by these agents. Therefore, safer agents that reverse insulin resistance by other (non-PPARγ activity) mechanisms may be preferred as anti-diabetic therapeutics.

P1736 is a non-PPARgamma insulin sensitizing compound and is being developed for the treatment of Type II diabetes. In the phase I trial single and multiple ascending dose studies were conducted in 30 and 22 healthy volunteers respectively, in The Netherlands. In the single ascending dose study, the molecule was dosed up to 1600 mg and, doses of 200 and 1000 mg were evaluated in the multiple ascending dose study. The compound was found to be well tolerated in both the studies.

No serious adverse event was observed in either study. P1736 did not show any adverse effects on liver function, did not cause blood plasma volume expansion or weight gain. No effect was seen on clinical chemistry and hematological parameters. Further studies are being planned to evaluate its safety and efficacy in diabetic patients.

Dr. Swati Piramal, Director, Piramal Group, said, “Piramal Life Sciences aims to reduce the burden of disease by finding new and affordable cures for unmet medical needs. Committed to the Group’s values - knowledge, action and care, it focuses upon nurturing innovation and breakthrough thinking to impact the lives of millions, in dynamic, nimble footed delivery and in making quality drugs accessible. We are happy and proud that we have achieved this milestone in our quest to find a cure for type II diabetic patients.

Dr. Somesh Sharma, Managing Director, Piramal Life Sciences, stated, “The successful completion of phase I trial of P1736 in Europe bears testimony to our efforts to build a diversified and strong pipeline of products to address unmet medical needs.” P1736 is likely to provide a safe and effective therapeutic option to type II diabetic patients. It also shows that PLSL is delivering on the investments being made in research.”

PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development. PLSL is focused on four therapeutic areas – Cancer, Diabetes, Inflammation and Infectious Diseases.