Theratechnologies, a Canada-based developer of therapeutic peptide products, has started screening of patients in a Phase 2 trial to assess tesamorelin as a treatment for muscle wasting in patients with chronic obstructive pulmonary disease (COPD).
Tesamorelin is a growth hormone-releasing factor (GRF) analogue that induces growth hormone production and its anabolic properties have led Theratechnologies to pursue its development in muscle wasting in patients with COPD as a second indication for the compound.
A previously concluded phase 2 trial in stable ambulatory COPD patients has demonstrated a statistically significant increase in lean body mass (LBM).
The study will evaluate the efficacy and safety of a daily administration of either a 2mg or 3mg dose of a new formulation of tesamorelin for a period of 26 weeks.
The double-blind, multi-center, placebo-controlled, randomized trial is expected to be conducted in 25 centers across US and Canada.
The company expects to enroll about 200 patients and the trial results are expected before the end of 2012.
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