Palatin Technologies (PTN) Announces Bremelanotide Phase 3 Met co-Primary Endpoints in HSDD
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Palatin Technologies, Inc. (NYSE: PTN)announced positive, statistically significant top-line results from the Reconnect Studies, its Phase 3 clinical trial program of lead drug candidate bremelanotide. The Reconnect Studies, investigating bremelanotide as an on-demand treatment for premenopausal women diagnosed with hypoactive sexual desire disorder ("HSDD"), met the pre-specified co-primary efficacy endpoints in both Phase 3 clinical trials.
"We could not be more pleased with the bremelanotide Phase 3 co-primary endpoint results. Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "I am especially grateful to all of the women who volunteered to be a part of these studies. I would also like to thank Palatin's employees and the many consultants and third-parties that contributed to the advancement of bremelanotide."
Johna D. Lucas, M.D., Chief Medical Officer of Palatin, said, "In Phase 3 trials bremelanotide was used as needed by premenopausal women with HSDD, with a single dose self-administered in anticipation of sexual activity. The Phase 3 studies demonstrated that bremelanotide provided a meaningful benefit for those patients who responded to the drug candidate. We look forward to the opportunity to provide a new and differentiated treatment option to the many women suffering from HSDD."
"Hypoactive sexual desire disorder is the most prevalent form of female sexual dysfunction," said Sheryl A. Kingsberg, Ph.D., Professor of Reproductive Biology at Case Western Reserve University School of Medicine, Division Chief, OB/GYN Behavioral Medicine, at University Hospitals Cleveland Medical Center, and a clinical investigator in the Reconnect Studies. "The distress component of HSDD reflects the profound negative impact that this condition can have on women's self-image, relationships and quality of life well outside the bedroom. In the Phase 3 trials we saw significant reduction in distress with use of bremelanotide."
Palatin expects to present additional results from the Reconnect Studies at future sexual medicine and women's health conferences and in peer reviewed journal publications.
Reconnect Studies Top-line Results Overview
The Reconnect Studies consist of two randomized, double-blinded, placebo-controlled Phase 3 studies, comparing the efficacy and safety of bremelanotide versus placebo in premenopausal women diagnosed with HSDD. The Reconnect Studies randomized 1,267 women with HSDD. The primary efficacy analysis population was the modified intent-to-treat (MITT) patient population, consisting of 1,202 women with HSDD in the United States and Canada. Patients self-administered either 1.75 mg of bremelanotide or placebo as needed in anticipation of sexual activity. The double blind or efficacy portion of each study consisted of a 24-week treatment evaluation period. The open-label safety extension portion of the Reconnect Studies is ongoing.
Based on discussions with the FDA, it was decided that the co-primary endpoints for the Phase 3 clinical trials were the Female Sexual Function Index: Desire Domain (FSFI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO) Item 13. Satisfying sexual events is a secondary endpoint. The FSFI-D is a validated patient reported outcome measurement tool of sexual desire in the context of overall sexual function. The FSDS-DAO Item 13 is a validated patient reported outcome measurement tool of distress related to sexual dysfunction, measuring personal distress associated with low sexual desire.
Clinical significance of co-primary endpoint study results was evaluated by an independent committee using multiple anchors of patient assessment of benefit, consistent with discussions with the FDA and guidance documents.
- Clinical Significance for the FSFI-D Subscale: Based on application of three selected anchors, a median value of 0.6 was set for defining clinical significance in baseline to endpoints changes in FSFI-D subscale scores.
- Clinical Significance for the FSDS-DAO Item 13 Score: Based on application of three selected anchors, a median value of 1.0 point improvement in FSDS-DAO Item 13 scores was set for defining clinical significance.
In the preliminary review of the overall safety population (1,247 patients), bremelanotide appeared to be well tolerated. The most frequent adverse event was nausea, which was generally mild in nature. The safety profile of bremelanotide was consistent with prior clinical experience, and no new or unusual safety issues were identified.
Conference Call/Audio Webcast Information
Palatin will host a conference call and audio webcast on Wednesday, November 2, 2016 at 9:00 a.m. Eastern Time. The live conference call can be accessed by dialing (888) 516-2443 (domestic) or (719) 457-2651 (international), and entering conference code 7590742. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin's website at http://www.palatin.com. A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial (888) 203-1112 (domestic) or (719) 457-0820 (international), and enter passcode 7590742. The audio webcast and telephone replay will be available through November 9, 2016.
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