COPD Drug for Muscle Wasting Enters Phase 2 Clinical Trial

Theratechnologies Inc., a Canadian-based developer of therapeutic peptide products, has begun 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 (COPD). That is according to a statement issued by the pharmaceutical company early last month.

A growth-hormone-releasing (GRF) analogue, tesamorelin induces growth hormone production in a specific, physiological manner. Its anabolic properties led researchers to pursue its development in muscle wasting in patients with COPD as a second indication for the compound. A previously conducted phase 2 trial in stable ambulatory COPD patients demonstrated a statistically significant increase in lean body mass (LBM).

The phase 2 trial, which is expected to examine 200 patients, will be a double-blind, multicenter, placebo-controlled, randomized trial and will study the efficacy and safety of the daily administration of 2mg-3mg doses of a new formulation of tesamorelin over a 26-week period. The study will be conducted in 25 centers across the U.S. and Canada, with results expected before the end of 2012.

“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, in a release issued by Theratechnologies. Casaburi is the lead investigator for the COPD clinical program.

The primary goal of this phase 2 study is to determine whether the administration of tesamorelin increases LBM as measured by dual-emission X-ray absorptiometry (DXA), as well as the effects of the tesamorelin on patient functionality and quality of life.