Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis

Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis

• Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns
  
  
• Preclinical data demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation
  
  
• Data expected 1Q calendar year 2025

CRANBURY, N.J., Nov. 25, 2024 /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 completion of enrollment in its Phase 2 Study of PL8177, a potent melanocortin-1 receptor (MC1R) agonist, in ulcerative colitis (UC). The study is evaluating the safety, tolerability, efficacy, pharmacokinetics, and biomarkers of orally administered PL8177 in adult patients with active UC. The last patient visit is expected to occur in the first quarter of 2025, with topline data expected shortly thereafter.

"UC is a chronic, often debilitating, and growing condition that currently affects more than one million people in the United States," stated Carl Spana, Ph.D., President and CEO of Palatin. "Prior data has demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and resolved damaging inflammation. By resolving inflammation rather than blocking it, oral PL8177 may provide efficacy to patients without the safety and tolerability concerns of immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns. Additionally, oral PL8177, as a preferable and more convenient once-daily pill, could provide an alternative to UC patients apprehensive about using injectable therapies."

"We look forward to sharing the results of this trial next quarter," noted Dr. Spana. "Our objective is to out-license the UC program. At this stage, there has been significant interest in and ongoing discussions around our UC program from multiple parties."

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining.² Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom.^2,3 The disease course varies between patients, and in some cases can lead to surgery or complications, including cancer or death.^3,4

Orally administered PL8177 targets melanocortin-1 receptors on the luminal surface of colon epithelial cells. In a Phase 1 clinical study, the oral formulation successfully demonstrated sustained delivery of PL8177 to the lumen of the colon with no systemic exposure.

The Phase 2 PL8177 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 for 8 weeks. The study was originally designed to enroll up to 28 adult subjects with active UC from multiple sites, with an interim analysis planned after completion of 12-16 subjects. Due to the strategic decision to out-license the UC program at an earlier stage, Palatin decided to end enrollment after 13 subjects. 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 measurement, the Mayo Endoscopic Subscore, which evaluates the level of disease in the colon mucosa. Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05466890.

The Company's Phase 2 trial in UC builds upon presented preclinical data from a series of oral PL8177 dose-ranging studies in the dextran sulfate sodium (DSS) colon inflammation model, which showed significant improvements in inflamed colon health, including relative increases in colon cells needed for a healthy colon. PL8177 treatment showed clear evidence of resolving pathological inflammation by repolarizing colon macrophages from a pro-inflammatory to a pro-inflammation resolving state.

About Melanocortin Receptor Agonists 
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.

About PL8177
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-1 receptor (MC1R), with sub-nanomolar affinity binding and EC50 functional values. Palatin data demonstrates that their oral formulation of PL8177 was protected from degradation in the stomach and small intestine of humans and delivered to the 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.

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. An estimated 1.25 million individuals in the United States are affected by ulcerative colitis, with over 350,000 diagnosed with moderate-to-severe disease.¹ 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.

About Palatin
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.

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 Palatin products in development, clinical trial results, 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 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 events that occur after the date of this press release.

Palatin Technologies^® is a registered trademark of Palatin Technologies, Inc.

¹ Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165(5). doi:10.1053/j.gastro.2023.07.003.
² The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed June 2024.
³ Ulcerative colitis. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326. Accessed June 2024.
⁴ Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014;27(2):95-104.

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