Palatin Technologies, Inc. Announces First-in-Human Study Results of Subcutaneous Administration of PL-8177, An Investigational Melanocortin Receptor 1 Agonist

Oral Formulation Clinical Data Currently Anticipated by Year End

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Nov 08, 2018, 07:30 ET

CRANBURY, N.J., Nov. 8, 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 Phase 1, first-in-human results of a single and multiple ascending-dose study of PL-8177, a patented melanocortin receptor 1 agonist with the potential application of treating ulcerative colitis and other inflammatory diseases. The data of subcutaneous administration of PL-8177 demonstrated favorable pharmacokinetics and pharmacodynamic properties and no safety or tolerability concerns were reported.

The objective of the Phase 1 study was to assess the safety and tolerability of PL-8177 and evaluate the pharmacokinetics and systemic exposure following both a single-ascending dose (SAD) and multiple-ascending doses (MAD) of PL-8177.

"Meeting all safety and study objectives of subcutaneous administration of PL-8177 is an important first step in the development of our second melanocortin peptide," said Dr. Carl Spana, CEO of Palatin Technologies. "We are very excited to continue development of PL-8177 and explore additional treatment opportunities. This demonstrates our expertise in and our commitment to the development of a robust pipeline of novel peptides targeting the melanocortin system. Our expansive library of MC1r peptides has the potential to treat a wide variety of inflammatory diseases, and we believe will continue to show positive results with further development."

The study enrolled 36 subjects who participated in the SAD stage and 20 subjects were enrolled and participated in the MAD stage of the randomized, double-blind and placebo-controlled Phase 1 study. All subjects in the SAD and MAD cohorts completed dosing. Overall, PL-8177 was well-tolerated when administered as a single and multiple ascending dose regimen, and a distinct pharmacokinetic profile was established in both the SAD and MAD parts of the study. No serious adverse events were reported in the SAD or MAD parts of the study.

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 anti-inflammatory responses and immunoregulation, including resolution of innate pro-inflammatory immune responses.

Data from a separate clinical study investigating an oral formulation of PL-8177 is currently expected by the end of 2018.

About PL-8177
PL-8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in animal inflammatory bowel disease models. 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.