Palatin Announces Initiation of Patient Recruitment for Phase 2 Clinical Study Evaluating Oral PL8177 for Treatment of Ulcerative Colitis

Study Designed to Evaluate the Safety, Tolerability, and Efficacy with PL8177 Oral Colon Delivery in Adult Subjects with Active Ulcerative Colitis

Oral PL8177 May Provide a Safe and Tolerable Treatment Option for Ulcerative Colitis Patients

CRANBURY, N.J., Sept. 8, 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 initiation of a Phase 2 clinical study of PL8177, a potent melanocortin-1 receptor agonist, in ulcerative colitis (UC). The study will evaluate the safety, tolerability, efficacy, pharmacokinetics, and biomarkers of orally administered PL8177 in adult patients with active UC. Clinical sites participating in the study have been activated, with screening and recruitment of potential patients underway.

"We are excited to advance oral PL8177, a potent, selective melanocortin-1 receptor agonist, into a Phase 2 clinical trial in patients with UC, an inflammatory bowel disease that affects an estimated one million people in the United States," stated Carl Spana, Ph.D., President and CEO of Palatin. "The melanocortin system plays an important role in the resolution of inflammation. The oral formulation of PL8177 is targeting melanocortin-1 receptors on the luminal surface of colon epithelial cells. In a prior phase 1 clinical study, the oral formulation successfully demonstrated sustained delivery of PL8177 to the lumen of the colon with no systemic exposure. Our goal is to establish PL8177 as a safe and tolerable treatment for patients eliminating or delaying immunosuppressive treatments that have safety and tolerability concerns."

The Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177, with once daily (QD) oral dosing in adult UC subjects. The study is designed to enroll up to 28 adult subjects with active UC from approximately 22 sites. All subjects who meet the eligibility criteria will be randomized to receive either placebo or oral PL8177.

"The initiation of Palatin's second clinical program evaluating a melanocortin based therapeutic in an inflammatory indication is an exciting milestone. We continue to compile compelling data that strengthens our belief in the potential for melanocortin therapeutics as safe and effective treatments for inflammatory and autoimmune diseases," concluded Spana.

The study uses an adaptive design with an interim assessment by an independent data monitoring committee after the initial 16 subjects have completed the 8-week evaluation visit. The efficacy evaluations and endpoints are in line with the latest FDA Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment (April 2022), including the primary efficacy endpoint the Mayo Endoscopic Subscore, which evaluates the level of disease in the colon mucosa.

The PL8177-205 interim assessment is expected to occur in the first quarter of calendar year 2023, with final topline data anticipated in the second quarter of calendar year 2023. Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05466890.

PL8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in multiple animal inflammatory bowel disease models. PL8177 is a potent, selective agonist at the human melanocortin receptor-1 (MC1r), with sub-nanomolar affinity binding and EC₅₀ functional values. Palatin data demonstrates that the oral formulation of PL8177 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 PL8177 had a significant effect on resolving inflammation in a rat bowel inflammation model.

PL8177 in oral formulations has demonstrated repeated, robust efficacy in ulcerative colitis disease models. MC1r is found on epithelial cells and resident macrophages of the colon which are accessible from the lumen of the colon. Orally administered PL8177 is not systemically absorbed. PL8177 has the potential for excellent efficacy without safety concerns.

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. An estimated 1 million 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 substantial portion of patients with moderate-to-severe ulcerative colitis, with certain severe cases resulting in surgical removal of the colon.

The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

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.

Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about clinical trial plans and potential results for PL8177, 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.