AMRI announced the selection of a compound from its proprietary obesity treatment research programme for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) in 2010.
AMRI's drug candidate is a novel MCH-1 receptor antagonist offering a promising new approach for the treatment of obesity. Melanin concentrating hormone (MCH) is a potent appetite stimulating peptide known to exert an effect on food intake and body weight regulation. In preclinical disease models, AMRI's small molecule antagonists of the MCH-1 receptor have demonstrated efficacy in rodent models of obesity, delivering weight loss that rivals currently available therapeutics, suggesting the potential for improved therapy in humans.
Pending favourable results in toxicity and safety pharmacology testing, AMRI estimates that it will submit an IND for this compound in the first half of 2010. Subject to FDA review, the submission of an IND would allow subsequent initiation of phase-I human clinical trials.
"We are pleased to announce this latest achievement emerging from our R&D efforts. This development results from our strategy of deploying dedicated resources and talent to create long term value for AMRI and its stakeholders," said chairman, CEO and president Thomas E D'Ambra. "This research programme leveraged AMRI's exceptional strength in medicinal chemistry and depth of expertise in metabolic diseases."
AMRI has filed a series of patent applications to protect the intellectual property associated with this programme, and plans to ultimately seek a licensee to commercialize the technology.
This announcement marks the sixth AMRI compound transitioned into an early stage preclinical candidate. Three of these candidates have moved into Phase I clinical testing, including two compounds from AMRI's biogenic amines program being studied for the treatment of central nervous system (CNS) disorders by Bristol-Myers Squibb Company as part of a licensing arrangement, and one from AMRI's independent tubulin inhibitor program, which is currently in Phase I testing in cancer patients.
Antagonism of the MCH-1 receptor is a promising new approach for the treatment of obesity.
Founded in 1991, Albany Molecular Research, Inc (AMRI) provides scientific services, products and technologies focused on improving the quality of life.