AMRI (NASDAQ: AMRI) has commenced enrollment for a Phase I study of ALB-127158(a), a novel MCH1 receptor antagonist offering a potential new approach for the treatment of obesity. The announcement was made yesterday during a presentation by AMRI's Dr. Peter Guzzo, director, discovery research and development, at the 6th Obesity and Diabetes Drug Development Summit in Arlington, VA. Preclinical data were also reported.
“We are very pleased to begin Phase I human testing of this promising new compound”
The clinical trial will be comprised of a single ascending dose study followed by a multiple ascending dose study to assess safety, tolerability and pharmacokinetics. The multiple ascending dose study will be conducted in overweight subjects to evaluate pharmacodynamics (the physiological effects of the drug candidate on the body), including caloric intake, hunger assessments and metabolic markers. The Phase I study is anticipated to be completed during the first quarter of 2011.
Preclinical studies of the AMRI compound have suggested promise for the treatment of human obesity. For example, in data presented by Dr. Guzzo, ALB-127158(a) showed high levels of MCH1 receptor occupancy leading to a sustained, dose-related reduction in food intake in dietary-induced obese mice. The ensuing weight loss of up to 18% after 28 days of administration was substantially higher than that from the currently available therapeutic agent, sibutramine. Weight loss was shown to be entirely due to a reduction in food intake leading to a preferential reduction in fat stores and was accompanied by significant improvements in glucose tolerance. Preliminary safety evaluation, including cardiovascular safety, was also reported; subsequent regulatory safety testing supported approval by the UK Medicines and Healthcare Products Regulatory Agency for initiation of the Phase I study.
"We are very pleased to begin Phase I human testing of this promising new compound," said Dr. Bruce Sargent, Ph.D., vice president, discovery research & development. "Obesity has become a serious health issue throughout much of the developed world and is a significant risk factor in a host of other health problems, including diabetes, cardiovascular and respiratory disease and cancer. A new agent that could provide an option to current treatments would provide benefits to patients and generate substantial market opportunities."
Dr. Sargent continued, "The advancement of this compound into Phase I studies is a tribute to the expertise and ingenuity of multiple scientific teams within AMRI, and further validates AMRI's ability to generate intellectual property with commercial potential for our customers. MCH1 receptor antagonism has been long recognized as a potential approach to treatment of obesity; we are excited to be one of the first companies to discover a compound suitable for clinical evaluation."
Yesterday's announcement marks the fourth compound from AMRI's internally funded R&D portfolio to advance into Phase I clinical testing. Previously announced Phase I study programs include two compounds from AMRI's biogenic amines program being studied for the treatment of central nervous system (CNS) disorders as part of a licensing agreement with Bristol-Myers Squibb Company (NYSE: BMY), and one from AMRI's proprietary anti cancer program.
By 2050, two-thirds of adults and one-third of adolescents could face obesity in the US