Clarus Therapeutics Initiates Phase 3 Clinical Trial of Oral Testosterone Replacement Therapy
NORTHBROOK, Ill. – May 17, 2016 – Clarus Therapeutics, Inc., a men's health specialty pharmaceutical company focused on the development and commercialization of JATENZOTM, its proprietary oral testosterone (T) replacement product (formerly REXTORO), today announced that it has begun dosing patients in its recently launched Phase 3 clinical investigation of Testosterone Undecanoate – the 'inTUne Trial'.
Dr. Robert Dudley, president and CEO of Clarus, commented, "After productive dialogue with the FDA regarding the complete response letter issued for our JATENZO NDA, we launched the inTUne Trial, our third Phase 3 trial. In our first two Phase 3 trials of JATENZO, we successfully demonstrated efficacy and safety consistent with approved T replacement products. We believe this additional trial will provide the supplemental data requested by the FDA and lead to approval of our NDA. There continues to be solid market demand for testosterone replacement products and physicians and their patients strongly favor a new oral alternative to currently approved options. Research has shown that current T therapies have poor compliance and that men with low T would prefer an oral alternative. We believe JATENZO has the potential to safely and effectively expand treatment options for men who need T replacement therapy."
The inTUne Trial is a multicenter, randomized, open-label, study designed to evaluate the efficacy and safety of JATENZO in adult hypogonadal male subjects. An active comparator group will receive Axiron – a topical testosterone formulation. Approximately 180 subjects will be randomly assigned to receive open-label treatment in a 3:1 ratio of oral JATENZO to Axiron. The primary efficacy time point for assessment of average T concentrations occurs on Day 105 of the study.
About Clarus Therapeutics
Clarus is an emerging men's specialty pharmaceutical company developing and preparing for the commercial launch of JATENZO, an oral testosterone replacement therapy. JATENZO is a T prodrug that, if approved by the FDA, will be used to treat men diagnosed with testosterone deficiency together with an associated medical condition, also known as hypogonadism. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO. For more information, please visit: www.clarustherapeutics.com.
JATENZO is a proprietary softgel oral formulation of testosterone undecanoate for treating hypogonadal men. Common symptoms identified in the Endocrine Society's clinical guidelines for hypogonadal men include reduced sexual activity and desire, decreased energy, increased body fat and reduced muscle mass, depressed mood and other emotional and physiological issues. Prior to its ongoing inTUne Trial, Clarus completed two Phase 3 trials of JATENZO and demonstrated primary efficacy in line with FDA guidance for T-replacement therapy (i.e., at least 75% of evaluable subjects with a serum T level in the normal range of 300 to 1,000 ng/dL) and a safety profile consistent with the class of T replacement products. The most common treatment-related side effects observed in some subjects were occasional mild GI disturbances, a modest decrease in HDL cholesterol and moderate increases in hematocrit and prostate-specific antigen (PSA).