Woodlands, Texas-based Repros Therapeutics has announced the debut of an advisory board that will oversee and advise on the clinical and commercial opportunities for their Androxal therapy. Androxal is billed by the Repros as “a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound.” Currently in Phase 3 testing, Androxal is aimed at men who suffer from low testosterone caused by secondary hypogonadism. According to Repros, the next steps for Androxal is the completion of the Phase 3 study in the fourth quarter of this year, as well as completion of an open label safety study at the same time with a Complete DEXA study scheduled for completion in the first part of 2014. As such the Texas firm is already looking forward to how best to commercialize their new therapy when it is ready to hit the market.
Repros is a firm that largely focuses on developing “small molecule drugs” meant to treat largely overlooked conditions that cause reproductive disorders in both genders. The firm assigned Professor Mike Wyllie, Ph.D., DSc, and Ron Wiehle, Ph.D., who are the Director and V.P. of Research and Development for Repros, respectively, with setting up an advisory board for the Androxal product. Along with advice on the next clinical steps and commercialization, the board will also be tasked with educating both primary care physicians and patients on the advantages of the treatment. According to Repros:
…it has become increasingly obvious that hypogonadism affects many facets of daily living and impacts adversely on patients’ quality of life. Correspondingly, treatment has evolved and now involves not just andrologists and urologists, but increasingly, endocrinologists. As with erectile dysfunction, it is anticipated that with the arrival of orally effective therapy, the management of hypogonadism will become the domain of primary care physicians. Primarily the urology and andrology disciplines are to be represented by Key Opinion Leaders (KOL)’s at the inaugural advisory board to be held in October 2013…
The firm also reports that a second advisory board, which will be made up mostly of primary care physicians and endocrinologists, will also be formed in short order. Mike Wyllie, Director of Repros, has expressed his satisfaction that so many quality professionals are willing to participate on the boards for Androxal as “it is important to prepare for the arrival of an effective oral therapy for the treatment of secondary hypogonadism and provide the right support for patients and providers.”