Orchid's US drug discovery JV progresses well on BLX 1002

Chennai: Orchid Chemicals & Pharmaceuticals Ltd, the city-based pharma major, says its joint venture (JV) in the US, Bexel Pharmaceuticals Inc (BPI), has made notable strides in its drug discovery activities over the last few months. The JV's lead molecule for diabetes (BLX 1002) has demonstrated excellent results and potential both in in-vitro and in-vivo toxicological and pharmacological studies.

Based on the results obtained so far, Orchid believes that this lead molecule for diabetes will be very well positioned not only for its exceptional efficacy and safety, but more importantly for its anti-weight gain property. Virtually all diabetes drugs have the problem of associated weight gain. Development of a molecule with anti-obesity properties will be a major stride in the new generation therapy of diabetes.

Orchid has, over the last few months, supported the fast tracking of the molecule in terms of optimising the process and providing GLP batches for various studies in the US. Orchid expects the synergies between its chemistry, molecular modelling and pre-clinical capabilities and Bexel's innovative structure design and biological experimentation to yield a richer drug candidate pipeline in the future.

According to a communication from the company, the molecule is now presently undergoing US Food and Drug Administration-compliant toxicity studies, which will be part of an eventual IND (investigational new drug) submission to the US FDA. Orchid expects the results of these studies to be available by August 2003, enabling commissioning of phase-I clinical studies thereafter.

Given the potential of this molecule, it is planned to complete phase-I and phase-II(a) human clinical studies before considering licensing opportunities. The molecule also received good response and enquiries from several leading multinational companies when it was showcased by BPI in the American Diabetes Association (ADA) two weeks ago.

Orchid and Bexel have chalked out an aggressive plan to complete phase-I studies this calendar year, followed by phase-II proof-of-concept studies early next year.