Glenmark reports positive phase 1 results for anti-diabetic inhibitor GRC 8200

By Elaine Rigoli

Tampa, Fla., Feb. 24 - The Swiss subsidiary of Glenmark Pharmaceuticals Ltd., Glenmark Pharmaceuticals SA, announced that its lead DPP-IV inhibitor candidate for diabetes, GRC 8200, has successfully completed its phase 1 study.

The study was filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom and was conducted by Parexel U.K., a global clinical research organization.

The objective of the phase 1 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, according to a company news release.

It was found that the compound was well tolerated by the subjects at all dosage levels and there were no significant adverse events reported, according to the release.

The study design included eight single-dose regimens with 800 mg as the highest dose. The pharmacokinetic profile of GRC 8200 was linear across the dosage range studied and was found to be favorable to support a once-daily regimen, the release said.

More than 90% inhibition of the DPP-IV enzyme was observed within one hour at all doses tested. The study also included three multiple dose (10 days) regimens with 300 mg/day as the highest dose.

GRC 8200 has now entered phase 2 testing with trials that are beginning in South Africa at an FDA-approved clinical research organization.

The company also intends to file a U.S. Investigational New Drug application for GRC 8200 by May 2006 for further phase 2 clinical testing and expects to complete all phase 2 trials by March 2007.

"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 U.S. market in 2010," said Glenn Saldanha, managing director and chief executive officer, in a statement.

Preclinical studies demonstrated GRC 8200 to be more potent (I.C. 50=1.61nM) than competing DPP-IV inhibitors. The compound is highly bioavailable (50% to 95% oral bioavailability across species) and safe, displaying significant reduction in glucose excursion on oral glucose challenge (50% to 75% across species), the release said.

Preclinical 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.

Glenmark is in early discussions with potential partners in the regulated markets to collaborate on the clinical development, filing and marketing of this product, the release said.

Mumbai, India-based Glenmark is a pharmaceutical company.

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