Repros’ to Initiate New IND for Androxal®

THE WOODLANDS, Texas --Repros Therapeutics Inc. (NasdaqCM:RPRX) has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency to initiate its Investigational New Drug (IND) Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial. The FDA noted no clinical hold issues, but added that it may have some comments on the specifics of the Phase II design. Doses to be tested in the Phase IIa study have been safely tested for longer durations in trials in men for the treatment of secondary hypogonadism.

The opening Phase IIa study is entitled, “A Randomized, Parallel, Double-Blind, Placebo Controlled and Open-Label-Active-Controlled Exploratory Study to Evaluate the Efficacy of Androxal in Improving Glycemic Control in Men with Secondary Hypogonadism or Adult-Onset Idiopathic Hypogonadotrophic Hypogonadism (AIHH) and Type II Diabetes Mellitus”. Repros plans to enroll a total of 60 men into three balanced parallel arms at several clinical sites comparing placebo to two active doses. The lead investigator for the study is Glenn R. Cunningham MD, Professor, Baylor College of Medicine, Division of Diabetes, Endocrinology & Metabolism, Departments of Medicine & Cellular Biology and the Medical Director, St. Luke’s Episcopal Hospital – Baylor Diabetes Program. Dr. Cunningham consulted with Repros in the development of the protocol.

To be included in the study men, age 20 to 80, must have been previously diagnosed with T2D mellitus as defined by the American Diabetes Association criteria for at least 6 months. The men must also have been receiving a stable dose of an oral hypoglycemic agent (OHA). The men must have a fasting serum glucose level of greater than 126 mg/dL but less than or equal to 220 mg/dL and HemoglobinA1c (HbA1c) between 7% and 9.5% while being treated with their prescribed OHA. The men must also exhibit a morning testosterone level of less than 300 ng/dL and a serum LH of between 1 and 8 mIU/ml.

Men will be treated for three months. The primary endpoints are the change in HbA1c from baseline to 3 months as well as the difference between placebo and the two active arms, the change in fasting blood glucose from baseline to months 1, 2, and 3 for each treatment group and the change in total testosterone from baseline to month 3.

Joseph S. Podolski, President and CEO of Repros noted, “The retrospective analysis from our previous study is interesting. However we should not underestimate the challenges in conducting studies in diabetes. We believe the protocol we have designed will determine if there is clinically significant signal that warrants further development.” He commented further that before proceeding with the study the Company must raise additional capital and is currently evaluating several different financing options.

Source: Repros Therapeutics Inc.