PipelineReview.com - Biotech News & Online Store - Glenmark’s anti-diabetic, DPP-IV inhibitor, GRC 8200 successfully completes Phase I

Glenmark’s anti-diabetic, DPP-IV inhibitor, GRC 8200 successfully completes Phase I

24 Feb 2006

Today announced that its lead DPP-IV inhibitor candidate for diabetes, GRC 8200, has successfully completed its Phase I study.

MUMBAI, India | Feb 24, 2006 | Glenmark Pharmaceuticals SA. [GPSA], the wholly owned Swiss subsidiary of Glenmark

Pharmaceuticals Limited [Glenmark], today announced that its lead DPP-IV inhibitor candidate for diabetes, GRC 8200, has successfully completed its Phase I study. The study was filed with the Medicines and Healthcare Products Regulatory Agency [MHRA] in the U.K. and was conducted by Parexel U.K., a leading global CRO.

The objective of the Phase I study was to assess the safety and bioavailability of GRC 8200 in humans and was conducted using single and multiple oral doses on 88 healthy volunteers. It was found that the compound was very well tolerated by the subjects at all dosage levels and there were no significant adverse events reported. The study design included eight single dose regimens with 800mg as the highest dose. The pharmacokinetic profile of GRC 8200 was linear across the dosage range studied and was found to be favourable to support a once-daily regimen. More than 90% inhibition of the DPP-IV enzyme was observed within 1 hour at all doses tested. The study also included three multiple dose [10 days] regimens with 300mg/day as the highest dose.

GRC 8200 has now entered Phase II testing with trials that are beginning in South Africa at a US FDA approved CRO. The Company also intends to file a US IND for GRC 8200 by May 2006 for further Phase II clinical testing and expects to complete all Phase II trials by March 2007.

Glenn Saldanha, Managing Director and CEO of Glenmark Pharmaceuticals Ltd., stated “There are several leading multinational companies who have lead molecules for DPP-IV inhibitors in early to late stage clinical trials. But with our aggressive timeline we hope to be the fourth to market with GRC 8200 in the DPP-IV class. We maintain our guidance for launching GRC 8200 in the US market in 2010.”

Pre-clinical studies demonstrated GRC 8200 to be many times more potent [I.C. 50=1.61nM] than competing DPP-IV inhibitors. The compound is highly bioavailable [50%-95% oral bioavailability across species] and safe, displaying significant reduction in glucose excursion on oral glucose challenge [50%-75% across species]. Pre-clinical studies 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.

In line with its policy of partnering its NCEs with strong development and marketing partners for North America, Europe and Japan, Glenmark is in early discussions with potential partners in the regulated markets to collaborate on the clinical development, filing and marketing of this product.

About Diabetes
Globally, Type II Diabetes is one of the most common chronic diseases. The pathological manifestations of the disease include obesity, hypertension, hyperlipidemia and cardiovascular diseases. Diabetes causes significant morbidity and mortality due to long-term micro and macro vascular complications. At current estimates, the global prevalence of Type II Diabetes will double from 171 million patients in 2000 to 334 million patients in 2025. The existing incidence of Type II Diabetes in the US is estimated to be 7 percent of the population; while spend on related treatment accounts for as much as 10 percent of all healthcare dollars in the US. Furthermore, the incidence of Type II Diabetes is increasing globally at a rapid rate especially in Africa, South America and Asia leading to the disease now being considered a worldwide 'epidemic'.

India leads the top 10 countries estimated to have the highest number of people with diabetes in 2000 and 2030, with China and the US following closely. It is predicted that the projected number of cases of diabetes in India will more than double from 31.7 million in 2000 to 79.4 million in 2030 [Source: Wild S., Roglic G. et al; Global Prevalence of Diabetes-estimates for the year 2000 and projections for 2030; Diabetes Care; 27:1047-1053]. The country's environmental and genetic factors, influenced by the changing socioeconomic scenario, have made an increasing number of Indians susceptible to this deadly epidemic. Based on recent epidemiological data, the growth rate of Type II Diabetes is estimated to be 12-16 percent in India, which is much higher than the global rate.

About Glenmark
Glenmark Pharmaceuticals Limited is a global, fully integrated, research-based pharmaceutical company headquartered in Mumbai, India. The Company has generic formulation and API business interests in over 70 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.

The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. Its first Asthma/COPD molecule, GRC 3886 [INN: ‘Oglemilast’], was licensed out to Forest Labs and Teijin Pharma for the North American and Japanese markets, respectively. This compound has subsequently completed Phase I clinical trials successfully and will be entering Phase II clinical trials in the US shortly. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, commenced Phase I clinical trials in the UK in October 2005. Glenmark’s third NCE, GRC 10389, is a Cannabinoid [CB-1] receptor antagonist which is presently completing its pre-clinical studies. The compound is a highly selective drug candidate targeting obesity and its associated disorders. [www.glenmarkpharma.com]

For further information, please contact
Ms. Vaijayanti Karande
Sr. Manager – Corporate Communications
Glenmark Pharmaceuticals Limited
Tel: [91-22] 5558 9999 [Ext. 913] / 5558 9913
Fax: [91-22] 5558 9986
Email: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

SOURCE: Glenmark Pharmaceuticals SA.

Search in our News Channels

Search in our Online Store