Palatin Announces Publication of Vyleesi® (bremelanotide) fMRI Study in Women with Hypoactive Sexual Desire Disorder (HSDD)

Peer-reviewed paper presents notable mechanism of action findings

Bremelanotide significantly increased sexual desire for up to 24 hours post administration

CRANBURY, NJ, Oct. 17, 2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the publication of a third-party clinical study with bremelanotide (Vyleesi) in the Journal of Clinical Investigation entitled "Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder," by Thurston, et al. (Reference: J Clin Invest. 2022;132(19):e152341. https://doi.org/10.1172/JCI152341). Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with HSDD.

The important findings in the double-blinded, placebo controlled, crossover study showed that bremelanotide enhanced sexual brain processing, including a significant increase in sexual desire for up to 24 hours after administration compared with placebo (statistically significant P ≤ 0.01). Increased satiety (appetite fullness feeling) and decreased food intake with bremelanotide treatment was also noted. Although other studies have been conducted showing the difference in sexual brain function between women with HSDD and non-HSDD women, this is the first trial to study the effects of melanocortin 4 receptor agonism with bremelanotide on sexual brain processing in women with HSDD.

"This extremely well-done clinical trial helps define Vyleesi's positive effects on sexual brain function and the relationship to increases in sexual desire in women with HSDD," stated Carl Spana, Ph.D., President and CEO of Palatin. "The study correlates imaging data with increased sexual desire for up to 24 hours post Vyleesi administration as reported by the participants. We are extremely excited and appreciative for this important data which demonstrates the beneficial impact of HSDD on the sexual brain and helps explain Vyleesi's mechanism of action in increasing sexual desire in women with HSDD."

The trial registration can be found at ClinicalTrials.gov under NCT04179734. This was an investigator-sponsored study funded by AMAG Pharmaceuticals Inc. (previous Vyleesi collaboration partner) and the Medical Research Council and National Institute for Health Research of the United Kingdom.

About Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD. Palatin is actively seeking Vyleesi collaborations for the United States and for territories outside the currently licensed territories of China and Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates 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 to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.

Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about Vyleesi results and potential market, 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 other regulatory 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.

Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.

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SOURCE Palatin Technologies, Inc.