Theratechnologies Launches Phase 2 Clinical Trial to Investigate Tesamorelin for the Treatment of COPD-Associated Muscle Wasting

Theratechnologies

announced today that it has initiated the patient screening process of its phase 2 clinical trial investigating tesamorelin for the treatment of muscle wasting in patients suffering from chronic obstructive pulmonary disease. This follows the investigator meeting, which took place in Montreal, Quebec, Canada, on August 27, 2011. The objective of the study is to evaluate the effects of two doses of a new formulation of tesamorelin on lean body mass, patient functionality and quality of life. "I am pleased that we have launched our COPD clinical program as planned and on schedule, in our pursuit of a second indication for our lead compound tesamorelin," said Mr. John-Michel T. Huss, President and Chief Executive Officer. "There are millions of patients worldwide suffering from COPD-associated muscle wasting and if successful, we will be able to address a currently unmet medical need," concluded Mr. Huss. Based on available market and industry data, the Company estimates that in 2010 there were approximately 3.1 million COPD patients in Global Initiative for Chronic Obstructive Lung Disease Stage II or III only, suffering from a muscle wasting condition with a body mass index under 25, when including the United States, France, Germany, Italy, Spain, United Kingdom and Japan. The COPD clinical program is a multi-center, double-blind, randomized, placebo-controlled phase 2 clinical trial. It is now open for the screening and enrollment of eligible patients and it will be conducted in up to 25 centers in the United States and Canada. The study will examine the safety and efficacy of a daily administration of either a 2 mg or 3 mg dose of a new formulation of tesamorelin for a period of 26 weeks. The primary endpoint is an increase in LBM as measured by dual-emission X-ray absorptiometry. The study will also assess the effect of tesamorelin on patient functionality and quality of life. This will include a six-minute walking distance test, quadriceps muscle strength and a St. George's Respiratory Questionnaire. The Company expects to enroll approximately 200 patients in the study and its results are expected before the end of 2012. Tesamorelin is a stabilized analogue of the growth hormone-releasing factor that induces growth hormone production in a specific and physiological manner. The anabolic properties of tesamorelin have led Theratechnologies to pursue its development in muscle wasting in patients with COPD as a second indication for the compound. A previously completed phase 2 trial in stable ambulatory COPD patients demonstrated a statistically significant increase in LBM. "Muscle-wasting in patients with COPD represents an important medical concern. If we can demonstrate that tesamorelin can reverse muscle loss, it could go a long way toward improving functionality of these patients in their daily activities and more generally, their quality of life," stated Dr. Richard Casaburi, Professor of Medicine at the UCLA School of Medicine and Medical Director of the Rehabilitation Clinical Trials Center of the Los Angeles Biomedical Research Institute. Dr. Casaburi is the Lead Investigator for the COPD clinical program.