EWING, N.J., April 03, 2017 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (ATRS) today announced that data from the 52-week pharmacokinetics and safety phase 3 study of subcutaneous testosterone enanthate delivered through the QuickShot® auto injector was selected for a moderated poster presentation at the Endocrine Society Annual Meeting (ENDO 2017). The poster will be presented today, April 3, 2017.
The poster, entitled “Safety, Efficacy, and Metabolic Parameters in the STEADY™ Trial of a Novel, Pre-Filled Subcutaneous Testosterone Enanthate Auto-Injector (SCTE-AI),” was authored by Christina Wang, MD, co-principle investigator for the study at Los Angeles Biomedical Research Institute and Harbor-UCLA Medical Center, Los Angeles, CA, et al. The submission was among a select group of key abstracts awarded the distinction of a moderated poster presentation.
The dose-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY™) trial of a proprietary, pre-filled auto injector enrolled 150 hypogonadal adult men with baseline testosterone (T) levels of <300 ng/dL. Patients received 75 mg of testosterone enanthate administered via auto injector once-weekly for six weeks. At week seven blinded dose adjustments were based upon the week six blood concentration levels at end of the dosing interval (Ctrough) in the patients. The primary endpoint was the percentage of patients achieving a Cavg of 300 to 1,100 ng/dL and a key secondary endpoint was percentage of patients with week 12 Cmax testosterone values of <1500 ng/dL. Markers of glucose metabolism (M) and insulin resistance risk (IR) were assessed via the Quantose™ insulin resistance (IR) panel. Quantose™ IR and M scores and cholesterol panel assessments were performed from blood samples at weeks 1, 13, 26, 38 and 52.
Of the 150 patients enrolled, 139 patients met the primary endpoint at week 12. Overall, the study found that QuickShot® testosterone (QST) administered to hypogonadal men achieved serum testosterone levels within a clinically desirable and physiologically normal range. Quantose™ IR and M scores suggested a large portion of the patient population exhibited a prediabetic/diabetic phenotype at baseline, and insulin resistance scores were decreased from baseline throughout the treatment period. Total cholesterol, triglycerides, LDL and HDL levels decreased with treatment. According to the investigators, QST was found to be safe, well tolerated and virtually pain free.
“We are pleased that data from our phase 3 QuickShot testosterone study has been accepted for presentation at the annual ENDO 2017 meeting,” said Robert F. Apple, CEO of Antares Pharma. Mr. Apple continued, “We believe data compiled to date from our QST clinical program have shown that adult men diagnosed with hypogonadism can achieve a steady pharmacokinetic profile for testosterone well within the physiologically normal range over the course of therapy. We also believe QST has been shown to be well tolerated and virtually painless. We will continue to work closely with the FDA during the regulatory review process toward a potential approval.”
The details for Dr. Wang’s poster presentation are as follows:
Date: Monday, April 3, 2017 Session: Male Reproductive Endocrinology II Session Time: 1:00 p.m. – 3:00 p.m. ET Location: Orange County Convention Center, Orlando, Florida – West Hall B
