Palatin Technologies, Inc. Initiates Subject Dosing in First-in-Human Clinical Study of PL-8177, an Investigational Melanocortin Receptor 1 Agonist

CRANBURY, N.J., Feb. 5, 2018 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced that the first healthy subjects have been dosed in a Phase 1 clinical study of PL-8177. The Phase 1 study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study intended to evaluate the safety and tolerability of PL-8177 administered via subcutaneous injection.  The study is designed to enroll up to 52 healthy volunteers.  Top line data is currently expected in the third quarter of 2018.

PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases. Evolving research suggests that the MC1r system plays an important role in immunoregulation, including resolution of innate pro-inflammatory immune responses.

"This is a significant milestone for Palatin, as this is our second melanocortin peptide to enter clinical development," said Stephen T. Wills, Chief Financial Officer and Chief Operating Officer of Palatin Technologies.  "Beyond bremelanotide, for which we expect to file an NDA with the FDA for female sexual dysfunction later this quarter, we continue to expand our pipeline of novel peptide therapeutics targeting the melanocortin system. We are excited about the potential of our MC1r peptides, which have the potential to treat a wide variety of inflammatory diseases.  We currently anticipate additional compounds entering clinical development later this year."

About PL-8177 

PL-8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in animal inflammatory bowel disease models.  Palatin has developed an oral formulation of PL-8177 that has been validated in animal studies, which is scheduled to be explored in future clinical investigations.  PL-8177 is a potent agonist at human MC1r, with sub-nanomolar affinity binding and EC₅₀ functional values. 

About Ulcerative Colitis 

Ulcerative colitis is a chronic disease of the large intestine (colon), with inflammation and ulcerations that can cause significant abdominal pain, persistent diarrhea, loss of appetite and other symptoms.  Over 700,000 individuals in the United States are affected by ulcerative colitis, with over 350,000 diagnosed with moderate-to-severe disease.  Existing treatments are not effective in a large portion of patients with moderate-to-severe ulcerative colitis, with some severe cases resulting in surgical removal of the colon.

About Palatin Technologies, Inc. 

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 www.Palatin.com. 

Forward-looking Statements 

Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about potential clinical indications for PL-8177, clinical trial results with PL-8177, potential actions by regulatory agencies including the 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.

SOURCE Palatin Technologies, Inc.