Palatin Technologies, Inc. (NYSE MKT: PTN) today reported positive top-line results, including the successful achievement of statistical significance for the primary endpoint and key secondary endpoints in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of female sexual dysfunction (FSD).
The data demonstrate that women taking bremelanotide showed statistically significant increases in the number of Satisfying Sexual Events (SSEs) and also showed statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared with placebo.
The primary endpoint data analysis of 327 pre-menopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or a combination of both disorders, the most common types of FSD, shows a clinically meaningful and statistically significant improvement (p=0.018) in the number of SSEs in women taking bremelanotide doses (mean change from 1.6 at baseline increasing to 2.4; pooled 1.25 mg and 1.75 mg doses) versus placebo (mean change from 1.7 at baseline increasing to 1.9) over the study period, resulting in a 50% increase in SSEs with bremelanotide versus 12% with placebo.
"We are extremely pleased to report the successful completion of this trial, which achieved statistical significance in our primary endpoint and key secondary endpoints using independently developed and validated measurement tools. Importantly, we met the objectives of the trial which demonstrated excellent safety and efficacy of the drug and identified doses for advancement into Phase 3 trials and activities" stated Carl Spana, Ph.D., President and CEO of Palatin. "Our next steps are to continue to compile and analyze additional data, to start the preparation process for an end-of-Phase 2 meeting with the FDA, and to further our discussions with potential collaboration partners."
In addition to meeting the primary endpoint, preliminary analysis of key secondary endpoints showed clinically meaningful and statistically significant improvement in patients who received bremelanotide vs. placebo (mean change from baseline to end of study; pooled 1.25 mg and 1.75 mg bremelanotide doses):
- Improved overall sexual function, as measured by the Female Sexual Function Index (FSFI). The FSFI is a 19-item questionnaire which provides for an additional measurement of changes over a longer recall period.
- FSFI total score improvement (mean change of 3.55 vs. 1.88, p=0.0017)
- Reduction in distress related to sexual dysfunction, as measured by the Female Sexual Distress Scale-DAO (FSDS-DAO). The FSDS-DAO 15-item questionnaire is designed to assess and quantify the change in personal distress associated with female sexual dysfunction.
- FSDS-DAO total score improvement (mean change of -11.1 vs. -6.8, p=0.036)
The primary endpoint and key secondary endpoints measurement period was defined as reported results during the last four weeks of treatment compared to the reported results during the baseline period. For all endpoints, the pre-specified statistical analysis as agreed to with the FDA was the pooled data for the 1.25 mg and 1.75 mg doses, compared to placebo.
Data analysis of the individual 0.75 mg, 1.25 mg and 1.75 mg bremelanotide doses each showed clinically meaningful improvement for the primary endpoint and key secondary endpoints, with the 1.75 mg dose achieving statistical significance for the endpoints cited above.
Jeff Edelson, M.D., Chief Medical Officer for Palatin stated, "These data provide an important demonstration of the safety and efficacy of bremelanotide and suggest its potential utility for the treatment of FSD in premenopausal women. Moreover, the trial provides important data that will be instrumental in planning Phase 3 clinical trials and activities. We look forward to working closely with our expert advisors, and the FDA, to identify next steps in the late stage clinical development of this exciting drug."
"These safety and efficacy trial results are very encouraging and clearly warrant further clinical testing of bremelanotide in this patient population. Despite the pressing need for such treatments, there are presently no FDA approved therapies for the treatment of female sexual disorders, conditions with major negative health impacts on patients," said Sheryl Kingsberg, Ph.D., Division Chief, OB/GYN Behavioral Medicine, UH Case Medical Center, and a clinical investigator on the study.
Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 395 patients. A total of 26 patients discontinued from the study based on predefined blood pressure criteria: these patients were evenly distributed across the placebo and bremelanotide dosing arms. An additional 12 patients discontinued from the study due to adverse events (N=12, Placebo: 2, bremelanotide arms 0.75 mg: 0, 1.25 mg: 4, 1.75 mg: 6). Adverse events that most commonly led to discontinuation were nausea and emesis.
The study was supervised by an independent Data Safety Monitoring Board. No serious adverse events were attributed to bremelanotide during the trial.
Detailed analysis of the data results in this trial will be presented at upcoming medical and scientific conferences and publications. Based on the results of discussions with the FDA and external advisors regarding the results of this trial and further development steps, Phase 3 activities are anticipated to start in the second-half of calendar year 2013.
Palatin Technologies, Inc.