Palatin Technologies Announces Positive Top Line Results of Oral Clinical Study of PL-8177 for Ulcerative Colitis and Other Inflammatory Bowel Diseases

Study Met All Primary and Secondary Endpoints

PL-8177 is a Melanocortin Receptor 1 Agonist

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Apr 04, 2019, 07:30 ET

CRANBURY, N.J., April 4, 2019 /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 positive results of a micro-dose study of radiolabeled PL-8177 using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL-8177 is a patented melanocortin receptor 1 agonist with potential application in treatment of ulcerative colitis and other inflammatory bowel diseases.

The main objective of the study was to demonstrate release of polymer-bound PL-8177 in the lower gastrointestinal tract after oral administration. Top line data showed favorable pharmacokinetics, and demonstrated PL-8177 was released in the lower gastrointestinal tract, supporting oral administration of PL-8177 using the delayed release polymer formulation.

A secondary objective of the study was also met, demonstrating that PL-8177 is not systemically absorbed after oral administration. There was no intact PL-8177 or its metabolite detected in plasma after oral administration. The oral formulation was well tolerated and there were no adverse events observed.

"The results of this study support moving forward with development of polymer-bound PL-8177 to deliver drug to the lower gastrointestinal tract to treat ulcerative colitis and other inflammatory bowel diseases," said Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. "Importantly, this study demonstrates that our oral, delayed-release polymer formulation of PL-8177 can deliver peptide to the diseased region of the bowel, without systemic uptake. The melanocortin receptor 1 is a novel target for treating ulcerative colitis and other inflammatory diseases, as it is present on the interior wall, or lumen, of the colon and lower gastrointestinal tract."

The lumen of the colon and lower gastrointestinal tract contains cells with receptors for melanocortin-1, which when activated by binding of PL-8177 can result in resolution of chronic inflammatory responses. The delayed release polymer formulation of PL-8177 is designed to protect the peptide until it reaches the lower gastrointestinal tract.

This open label study enrolled 24 subjects divided into 6 cohorts of 4 patients each. Blood, urine and feces samples were analyzed for total radioactivity and radiolabeled PL-8177 and its metabolite. The percentage of intact radiolabeled PL-8177 and its metabolite was measured at different timepoints following administration of a single oral microdose of polymer-bound radiolabeled PL-8177.

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