Orchid Chemicals & Pharmaceuticals Ltd is consolidating its New Drug Discovery (NDD) research activities under a common umbrella. As part of this initiative, the company and Bexel Pharmaceuticals, Inc have reached an understanding by which the company would extend its ownership in Bexel from the current 74% to 100% for a cash consideration of US$ 3 million. .
Both companies believe that bringing all drug discovery activities under a unified structure will provide seamless integration of the several drug discovery programmes being pursued at the company and Bexel while retaining the advantages of having a discovery front-end in the US and a discovery cum developmental back-end at the company, Chennai. The company has already established a wholly owned subsidiary, Orchid Research Laboratories Ltd (ORLL), to channel its drug discovery work.
The arrangement involves buy-out by the company of the shareholding of the US founders of Bexel Pharmaceuticals for a cash consideration of US$ 3 million. The founders and key employees of Bexel would be granted 650,000 stock options as per standard Orchid ESOP guidelines, which they will subscribe at the grant price.
In an independent arrangement, Bexel would be providing an earn-out to the principal founder of Bexel in the event of an out-licensing deal for BLX-1002 materialising in a prescribed timeframe based on the phase II clinical trials that are planned. The managerial and scientific organization of Bexel will continue as an integral part of the new structure, providing continuity and commitment to the company's broader drug discovery thrust.
Bexel has been focusing on drug discovery research in metabolic diseases (such as diabetes, obesity and auto-immune diseases) while the company has been focusing on inflammation, cancer and anti-infective areas. Bexel's anti-diabetes molecule BLX-1002 has progressed the most among these, having completed phase I safety and tolerability studies in healthy human volunteers as well as safety and tolerability studies in diabetic patients.
The phase I human clinical trials conducted in 4 stages so far have been successful without any adverse side effects being seen. Besides glucose lowering in diabetic patients, the compound also showed additional benefit of lowering of triglycerides and hypertension. These and certain other studies recently completed suggest the need for extended human clinical trials to profile the benefits in different arms of patients.
Bexel and the company are now planning to conduct more elaborate phase II human clinical trials on BLX-1002 in the context of its efficacy in multiple indications. These will be conducted in two stages of a 28-day human clinical study followed by a 90-day study if necessary to generate significant additional data on the compound. These trials will be carried out under the Investigational Medicinal Product Dossier (IMPD) procedure in Europe. Other biological studies are being undertaken in parallel to identify the mechanisms of action in the context of efficacy in diabetes and related complications.
Besides BLX-1002 and its supportive anti-diabetic NCE pipeline the company and Bexel have several leads with therapeutic potential in varied areas. These include a new anti-obesity lead and two anti-inflammation and anti-cancer leads from the company, which are targeted to move into human clinical studies upon the completion of the advanced preclinical studies currently underway.