NORTHBROOK, Ill., June 22, 2014 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc. , a men's health specialty pharmaceutical company focused on the development and commercialization of REXTORO ( (Testosterone Undecanoate), an oral testosterone (T) replacement product, today presented Phase 3 clinical data from two studies that support the safety and efficacy of REXTORO for T-replacement therapy in men with hypogonadism. These results are being presented from 1-3 p.m. CT today at the 16 th International Congress of Endocrinology and The Endocrine Society's 96 th Annual Meeting and Expo (ICE/ENDO 2014) in Chicago during the clinical poster session, "Male Reproduction: Hypogonadism and Reproductive Aging."
Ronald Swerdloff, M.D., of the L.A. Biomedical and Research Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA and Chief, Division of Endocrinology at Harbor-UCLA Medical Center, will present results from the two multi-center Phase 3 trials. These data add to the body of clinical results supporting REXTORO's position as a drug candidate for T-replacement therapy with a proprietary testosterone undecanoate formulation that utilizes a Self-Emulsifying Drug Delivery System (SEDDS) for oral administration.
"These Phase 3 data demonstrate that Clarus' REXTORO met the efficacy endpoint in both studies with the convenience of oral administration," said Robert E. Dudley, Ph.D., CEO of Clarus Therapeutics. "The data underscore REXTORO's potential as a well-tolerated, oral therapeutic that eliminates the medication transference risks related to contact with gel-based T-replacement therapies."
Both studies were conducted jointly by Clarus Therapeutics, the L.A. Biomedical and Research Institute and the David Geffen School of Medicine at UCLA to develop and commercialize an oral testosterone therapeutic. Phase 3 data presented at ICE/ENDO 2014 includes:
"Pharmacokinetics and Efficacy of a New S.E.D.D.S. Formulation of Oral Testosterone Undecanoate (TU) in Hypogonadal Men: Data from Two Phase 3 Trials with Different Dose-Titration Algorithms"
| Program: | Abstracts - Orals, Poster Preview Presentations and Posters |
| Session: | SUN 0071-0102-Male Reproduction: Hypogonadism and Reproductive Aging -- Clinical |
| Poster: | Poster Board SUN-0088 |
| Location: | Hall F (McCormick Place West Building) |
| Date: | Sun., June 22, 2014: 1-3 p.m. |
This study was conducted to determine the pharmacokinetic profile and efficacy of REXTORO in hypogonadal men at steady state in two Phase 3 clinical trials. The primary endpoint of this study was to determine efficacy by assessing the percentages of treated subjects who had 24-hour serum testosterone (T) average concentrations (C avg ) between 300 and 1000 nanograms per deciliter (ng/dL).
The secondary endpoints of this study sought to determine the percentages of treated subjects that had maximum serum T concentration (C max ) values that were: a) less than or equal to 1,500 ng/dL; b) Greater than 1,800 ng/dL and less than or equal to 2,500 ng/dL; and c) Greater than 2500 ng/dL.
Both trials recruited hypogonadal men (serum T ≤ 300 ng/dL) age 18-75 years old into open-label, multicenter, dose-titration trials. Trial I was a randomized, active-controlled, 2-arm, 12-month study in 325 hypogonadal men. Participants were randomized to either REXTORO (n=162) or 1% AndroGel® (n=163), a commonly prescribed T-replacement therapy. Meanwhile, Trial II was a single-arm 114-day study with oral TU (n=144). The starting dose of oral TU (as T equivalents) in both studies was 200 mg twice a day dosed with food. There were up to 2 dose-titration opportunities, but the trials differed in: 1) Timing of the post-dose sample used for dose titration (Trial I: 4-6 hours, Trial II: 3-5 hours); 2) T concentration thresholds for dose adjustment (Trial I: 250-1100 ng/dL, Trial II 250-700 ng/dL); and 3) size of the dose adjustment (Trial I 100 mg, Trial II 50 mg T equivalent).
Both trials demonstrated T replacement and with the revised dose-titration algorithm the C max was comparable to other T replacement therapies.
"Safety of a New S.E.D.D.S. Formulation of Oral Testosterone Undecanoate (TU) in Hypogonadal Men: Data from Two Phase 3 Trials with Different Dose-Titration Algorithms"
| Program: | Abstracts - Orals, Poster Preview Presentations, and Posters |
| Session: | SUN 0071-0102-Male Reproduction: Hypogonadism and Reproductive Aging-Clinical |
| Poster: | Poster Board SUN-0089 |
| Location: | Hall F (McCormick Place West Building) |
| Date: | Sun., June 22, 2014: 1-3 p.m. |
This study evaluated the safety of REXTORO in hypogonadal men in two Phase 3 clinical trials. Each trial differed in design, dose-titration algorithm and duration as noted above.
Trial I evaluated the safety profile of REXTORO for up to 365 days of continuous therapy compared with transdermal T-gel, and Trial II evaluated the safety profile of REXTORO for up to 114 days using the final dose-titration algorithm that results in a lower T exposure.
Safety was assessed through adverse event (AE) reporting, physical exams, routine clinical laboratory and dihydrotestosterone (DHT) measurements.
No deaths occurred in either trial. These two Phase 3 studies demonstrate that the SEDDS formulation of oral TU utilized in REXTORO has a safety profile consistent with T-gel and is generally well tolerated in men with hypogonadism.
In May 2014, the Company submitted to the FDA data for a Phase 4 open-label, 12-month follow-up safety study of REXTORO ® , the final report of which is expected in August 2014.
About Clarus Therapeutics
Clarus is an emerging men's specialty pharmaceutical company preparing for the commercial launch of REXTORO, an oral testosterone, or T, replacement therapy. On January 3, 2014 the Company submitted a New Drug Application, or NDA, for REXTORO to the U.S. Food and Drug Administration, or FDA. REXTORO is an oral 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 REXTORO. For more information, please visit: www.clarustherapeutics.com .
About REXTORO
REXTORO is a proprietary softgel oral formulation of testosterone undecanoate for treating hypogonadal men. According to a study published in the International Journal of Clinical Practice in 2006, T deficiency affects approximately 39% of men over the age of 45. Common symptoms identified in the Endocrine Society's clinical guidelines that suggest testing for T deficiency include reduced sexual activity and desire, decreased energy, increased body fat and reduced muscle mass, depressed mood and other emotional and physiological issues. Clarus completed two Phase 3 trials of REXTORO and achieved the FDA guidance for efficacious T-replacement therapy, which is at least 75% of evaluable subjects with a serum T level in the normal range of 300 to 1,000 ng/dL, in each of the Phase 3 trials. The observed safety profile for REXTORO with the final dose titration regimen was closely aligned with, but did not precisely meet, the FDA's target of 2,500 ng/dL for peak T concentrations. The most common treatment-related side effects were occasional mild GI disturbances in some subjects, a modest decrease in HDL cholesterol and side effects associated with increases in hematocrit, enlargement of the prostate or increases in prostate-specific antigen (PSA).
Media Contact: The Ruth Group Melanie Sollid-Penton Tel: 646-536-7023
