Piramal Life Sciences (PLSL), part of the Piramal Group of companies, has commenced phase II study of P1736-05, in India & Europe. P1736 is a non-PPARgamma insulin-sensitizing compound and is being developed for the treatment of type II diabetes.
Piramal Life Sciences has been granted an approval by Indian regulatory authorities to conduct phase II clinical trial in India. In Europe, phase II study is approved by various regulatory authorities in European Union like CCMO (Netherlands), NIP (Hungary) and SIDC (Czech Republic). P1736-05 has undergone extensive evaluation in various phase I studies conducted in central Europe under the approval of European authorities (CCMO- Netherlands) and proved to be very safe.
Dr Swati Piramal, director, Piramal Group, said, "PLSL 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, using high technology science for innovation to improve accessibility for patients with diabetes. We are happy and proud that we have achieved this milestone in our quest to find a cure for type II diabetic patients.
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 per cent of the diabetic population. In the US, 20.8 million people, i.e. about 7 per cent of the total population suffer 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 (PPAR?) activation by these agents. Therefore, safer agents that reverse insulin resistance by other (non-PPAR? activity) mechanisms may be preferred as anti-diabetic therapeutics.
Dr Somesh Sharma, managing director, PLSL, stated, “The commencement of phase II trial of P1736 in India and Europe speaks of our efforts to build a diversified and strong pipeline of products to address unmet medical needs. P1736-05 is likely to provide a safe and effective therapeutic option to type II diabetic patients."