Theratechnologies has received US Food and Drug Administration (FDA) clearance to initiate a Phase II safety clinical trial of its ThGRF (TH 9507) growth hormone-releasing factor analogue in patients with controlled type II diabetes, who make up a significant percentage of the population targeted by the Company's peptide. Theratechnologies is already conducting four Phase II clinical trials in Canada and Europe with its ThGRF compound.
Theratechnologies' clinical development program for ThGRF includes its use for the treatment of muscle wasting observed in chronic obstructive pulmonary disease (COPD) and hip fractures, and for the treatment of immune dysfunctions and sleep disorders. Current growth hormone products have been shown to induce insulin resistance and are contraindicated in diabetic patients. In contrast, GRF has been shown not to adversely affect insulin metabolism in older patients in previously published reports. It is anticipated that a significant number of patients to be enrolled in future clinical trials of TH 9507 will have glucose intolerance and overt diabetes.
In a Phase 1b study, TH 9507 increased IGF-1 levels in healthy men aged 50 to 60 to levels typically observed in young adults. Since TH 9507 has the natural sequence of GRF and is relatively resistant to degradation by peptidases in serum, it combines three key features for optimal efficacy and safety in aged patients: specificity on GH secretion; induction of GH secretion in a pulsatile, physiologic manner; and a powerful effect on IGF-1 secretion. These characteristics are expected to translate into clear clinical benefits in a number of targeted therapeutic indications. Therefore the purpose of this study is to confirm the safety of daily administration of TH 9507 in patients with controlled type II diabetes, in particular, by measuring its effects on insulin sensitivity and diabetic control.
The primary objective of this trial will be to evaluate the safety of two doses of TH 9507 (I mg and 2 mg) administered over 12 weeks by daily subcutaneous injections in approximately 45 patients with stable type II diabetes. It will be a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The lead clinical investigator for this trial is Dr. David R. Clemmons, Professor of Medicine Endocrinology, at the University of North Carolina School of Medicine, an expert in the field of diabetes.