Piramal Life Sciences Ltd, part of the Piramal Group of companies, has commenced a phase I study of a new, orally active glucose-lowering compound, P1736, in The Netherlands.
P1736 is a non-PPAR compound and is being developed for the treatment of type II diabetes. The compound is significantly different from the currently marketed drugs, as it does not have any adverse side effects on liver function, blood plasma volume expansion or those related to weight gain.
The drug is being tested in a trial that will enrol 72 normal healthy volunteers. The primary objective of the study is to determine the safety and tolerability of P 1736 prior to examining its efficacy in type 2 diabetes patients.
Piramal Life Sciences had submitted the Clinical Trial Application (CTA) for P1736 to the Central Commission on medical research Involving Human Subjects (CCMO), the regulatory authority of The Netherlands, and the Independent Ethics Committee of the foundation Evaluation of Ethics in Biomedical Research (BEBO), Assen, The Netherlands. Both these bodies have approved the company's application to initiate the phase I study of P1736.
Significantly, an oral presentation of the preclinical data pertaining to this compound will be made at the forthcoming congress of the American Diabetes Association (ADA), to be convened in June this year at San Francisco, California, USA.
Dr Somesh Sharma, managing director, Piramal Life Sciences, stated, "This is our sixth entity to enter the clinic and bears testimony to our efforts to build a diversified and strong pipeline of products to address unmet medical needs".
Piramal Life Sciences Ltd (PLSL) is an independent research driven drug company that was recently demerged from Nicholas Piramal India Ltd (NPIL, name proposed to be changed to Piramal Healthcare Limited, subject to shareholders' and Central Government's approval). PLSL was formerly the NCE R&D division of NPIL. It has focused on four therapeutic areas - cancer, diabetes, inflammation and infectious diseases. The company has a pipeline of fourteen compounds, including four in clinical trials.
PLSL is expected to be listed on the National Stock Exchange and the Bombay Stock Exchange by June 2008.