ALBANY, N.Y.--(BUSINESS WIRE)--AMRI (NASDAQ: AMRI) announced today the results from its Phase I clinical study on its novel MCH1 receptor antagonist, ALB-127158(a). The results indicate that ALB-127158(a) is well tolerated at the doses tested and shows preliminary evidence of efficacy.
The results were presented at the 18th European Congress on Obesity by Dr. Nicholas Moore, director of development and pharmacology at AMRI. The placebo-controlled study evaluated the safety, tolerability and efficacy of ALB-127158(a) in male volunteers. The study consisted of three components: a single ascending dose arm (SAD) in lean subjects (BMI ≤ 25), a fed/fasted crossover in overweight subjects (BMI ≥ 27) and a 14-day ascending dose arm (MAD) in overweight subjects. Standard safety assessments, ECG monitoring and PK measurements were conducted.
ALB-127158(a) was well tolerated in both the SAD and the MAD; reported events were mild and showed little dose relationship. One of the most common events reported in both the SAD and the MAD was loss of appetite. No drug-related changes in cardiovascular parameters or sleep were observed during any phase of the study. Reductions in “hunger,” “desire to eat,” and test meal consumption were observed. The study met both its primary and secondary objectives, demonstrating safety and tolerability. The data support the continued development of ALB-127158(a) as a potential treatment for obesity.
“We are pleased with these Phase I results for our compound,” said Dr. Bruce Sargent, Ph.D., senior vice president of drug discovery, “MCH1 receptor antagonism has been long recognized as a potentially important approach to treatment of obesity, however, multiple attempts to progress therapeutic agents have been thwarted by non-target related safety issues. We believe that our results are the first to demonstrate good tolerability and pharmacokinetics and therefore support the further evaluation of this molecule.”
About the MCH1 Receptor and ALB-127158(a)
Melanin concentrating hormone (MCH) is a potent appetite stimulating peptide known to exert an effect on food intake and body weight regulation. The endogenous peptide MCH has been shown to regulate energy homeostasis through the MCH1 receptor located in 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 MCH1 receptor has been shown to reduce food intake in rodents and hence reduce body weight, selectively reducing fat stores. Representing a potential new approach for the treatment of obesity, this target has been a focus of interest in many pharmaceutical companies but most programs have stalled in the face of preclinical safety challenges.
Preclinical studies of ALB-127158(a) suggested promise for the treatment of human obesity. For example, the compound 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 in such mice of up to 18% after 28 days of administration was substantially higher than that from the previously established obesity drug, sibutramine. Weight loss was shown to closely correlate with a reduction in food intake leading to a preferential reduction in fat stores and was accompanied by significant improvements in glucose tolerance. Preclinical safety evaluation, including cardiovascular safety, supported approval by the UK Medicines and Healthcare Products Regulatory Agency for initiation of the Phase I clinical study.
Founded in 1991, Albany Molecular Research, Inc. (AMRI) provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world’s leading healthcare companies. As an additional value added service to its customers, the company is also investing in R&D in order to expand its contract services and to identify novel early stage drug candidates with the goal to outlicense to a strategic partner. With locations in the United States, Europe, and Asia, AMRI provides customers with a wide range of services, technologies and cost models.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These statements include those regarding the progress of the Company’s clinical trials, including its Phase 1 trial with ALB-127158(a) for the treatment of obesity. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about early stage clinical trial results is not necessarily indicative of clinical efficacy and does not ensure that later stage or larger scale clinical trials will be successful. For example, ALB-127158(a) may not demonstrate promising therapeutic effect; in addition, this compound may not demonstrate an appropriate safety profile in further pre-clinical testing and in current, later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or any potential partner to discontinue development. Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from analysis of data or from additional data or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with the Company’s view of the data or require additional data, information or studies. In addition, the planned timing of initiation and completion of clinical trials for ALB-127158(a) are subject to the ability of the Company to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved. Moreover, drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Furthermore, AMRI may not have the financial or human resources to pursue drug discovery successfully in the future. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities see the Company’s periodic reports filed with the Securities and Exchange Commission, including the risks and uncertainties included in the Annual Report on Form 10-K for the year ended December 31, 2010 and the Company’s subsequent SEC filings. The Company does not undertake any obligation to and does not intend to publicly update any forward-looking statements contained in this press release.