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Tech Valley News
AMRI Advances New Obesity Treatment
AMRI announced the selection of a compound from its proprietary obesity treatment research program for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application with the U.S. Food and Drug Administration 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 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 favorable 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, Ph.D. “This research program 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 program, and plans to ultimately seek a licensee to commercialize the technology.
Today's 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 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. The endogenous peptide MCH is believed to regulate energy homeostasis through neurons in the lateral hypothalamic area of the central nervous system (CNS). It is known to stimulate feeding in rats and promote increases in glucose, insulin and leptin levels, mimicking the human metabolic syndrome.
Antagonism of the MCH‑1 receptor has been shown to reduce food intake and hence reduce body weight, selectively reducing fat stores. This target has been a focus of interest in many pharmaceutical companies but most programs have stalled in the face of preclinical safety challenges.
AMRI's candidate compound has performed remarkably well in early preclinical safety studies and has potential to demonstrate an appropriate balance of efficacy to safety.
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