Palatin Technologies Reports Positive Results for Phase 2B Bremelanotide Female Sexual Dysfunction Trial
Statistical Significance Achieved for Primary Endpoint and Key Secondary Endpoints Teleconference and Webcast to be held at 10:00 a.m. ET on Thursday, November 8, 2012
CRANBURY, NJ – November 8, 2012 – 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.
o 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.
o 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.
Approximately 400 premenopausal women, diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both, were enrolled in the study. Patients were treated for 16 weeks and were randomized to one of four double-blind treatment groups and received placebo or bremelanotide doses of 0.75, 1.25, or 1.75 milligrams.
The trial was a multi-centered, randomized, placebo-controlled, parallel-group dose-ranging trial designed to evaluate the safety and efficacy of three subcutaneous (SC) bremelanotide fixed doses intended for on-demand use in premenopausal females with FSD. The pharmacokinetics of SC bremelanotide was also assessed during this trial.
The objectives of the Phase 2B trial were to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to Phase 3 clinical studies and activities.
About Female Sexual Dysfunction
Female Sexual Dysfunction (FSD) covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. FSD includes four categories: Sexual Desire Disorders (hypoactive sexual desire disorder [HSDD], sexual aversion disorder), Female Sexual Arousal Disorder (FSAD), Female Orgasmic Disorder (FOD), and Sexual Pain Disorders (dyspareunia, vaginismus). To establish a diagnosis of FSD, one or more of these disorders must be associated with personal distress, as determined by the affected women. In the 2008 PRESIDE study (Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking, reference: Obstet Gynecol. 2008 Nov: 112(5):970-8), Shifren and colleagues studied over 30,000 US women, reporting an age – adjusted point prevalence of sexual difficulties causing personal distress in 12% of respondents.
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand treatment for FSD and has the potential to transform the treatment of patients with FSD.
Bremelanotide for Sexual Dysfunction
Palatin is developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women diagnosed with FSD. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
Palatin will host a conference call and webcast on November 8, 2012 at 10:00 a.m. Eastern Time to discuss the results of its Phase 2B clinical trial in greater detail. Individuals interested in listening to the conference call live can dial 1-888-471-3843 (domestic) or 1-719-325-2491 (international), pass code 1406375. The webcast and replay can be accessed by logging on to the “Investor/Media Center-Webcasts” section of Palatin’s website at http://www.palatin.com. A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), pass code 1406375. The webcast and telephone replay will be available through November 15, 2012.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at http://www.palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about clinical trial results, potential actions by regulatory agencies including the U.S. Food and Drug Administration (FDA), regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
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