Palatin Technologies Presents Preclinical Oral Formulation Data on PL-8177, An Investigational Melanocortin Receptor 1 Agonist for Inflammatory Bowel Diseases

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Apr 03, 2018, 07:30 ET

CRANBURY, N.J., April 3, 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 the presentation of a poster on preclinical studies of an oral formulation of PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide. The presentation was made at the 2018 Keystone Symposia on "The Resolution of Inflammation in Health and Disease" held March 24-28, 2018 at the Royal Dublin Society, Dublin, Ireland. PL-8177 is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases.

The data demonstrates that the oral formulation of PL-8177 was protected from degradation in the stomach and small intestine and delivered to the large intestine and colon over an extended period. In addition, orally administered PL-8177 had a significant effect on resolving inflammation in a rat bowel inflammation model. The poster can be found on the Palatin website at https://www.palatin.com/resources/corporate-presentation/poster-presentations/.

"The development of an orally administered capsule of PL-8177 is a major step forward for our ulcerative colitis program," said Carl Spana, Ph.D., CEO and President of Palatin Technologies. "We are moving the oral formulation into human pharmacokinetic studies, which we currently anticipate beginning in the fourth quarter of 2018."

PL-8177 is the subject of a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study intended to evaluate the safety and tolerability of systemic exposure of PL-8177 administered via subcutaneous injection. Subject dosing is ongoing with top line data currently expected in the third quarter of 2018.

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 the 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

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.