India leads the top 10 countries estimated to have the highest number of diabetics in 2000 and 2030, with China and the US following closely. Type II Diabetes, one of the most common chronic diseases globally, is fast gaining epidemic proportions throughout the world, with pathological manifestations including obesity, hypertension, hyperlipidemia and cardiovascular diseases. Since diabetes causes significant morbidity and mortality due to long-term micro and macro vascular complications, new drugs are required to combat it.
Glenmark Pharmaceuticals has recently filed for Phase I clinical trials for GRC 8200, its leading DPP-IV inhibitor compound, with the Medicines and Healthcare Products Regulatory Agency [MHRA] in the U.K. The dipeptidylpeptidase IV [DPP-IV] target is associated with glucose dependent insulin secretion and peripheral insulin resistance. While no DPP-IV inhibitor has been approved for marketing till date, among the scientific community DPP-IV inhibitors are expected to offer significant potential for being the therapy of choice, once approved.
The Phase I study will be conducted by Parexel U.K., a leading global CRO. The Phase I study is expected to be completed in February 2006 and will be conducted using single and multiple oral doses on healthy volunteers. The objective of this study is to assess the safety and bioavailability of GRC 8200 in humans. Pre-clinical studies have demonstrated GRC 8200 to be many times more potent than competing DPP-IV inhibitors. The compound is highly bioavailable and safe, displaying significant reduction in glucose excursion on oral glucose challenge. Pre-clinical studies have also demonstrated that GRC 8200 has the potential of being a long-acting compound with high selectivity to the DPP-IV target over DPP-II, VIII and IX.
Glenn Saldanha, Managing Director and CEO of Glenmark, states "We have a very aggressive timeline and hope to be the fourth to market with GRC 8200 in the DPP-IV class. We expect GRC 8200 to be launched on the US market in 2010."