Palatin Reports Positive Phase 2 Results for Oral Melanocortin-1 Agonist in UC Study

Palatin Technologies, Inc., a biopharmaceutical company known for its pioneering medicines targeting the melanocortin receptor system, has announced promising results from their Phase 2 clinical trial of PL8177. This trial focused on adult patients with active ulcerative colitis (UC), evaluating the safety, tolerability, and efficacy of the oral administration of PL8177, a selective melanocortin-1 receptor (MC1R) agonist.

The results were compelling, with significant achievements in clinical remission and response among patients taking PL8177. Clinical remission was observed in 33% of patients receiving PL8177 compared to none in the placebo group. A notable clinical response, statistically significant, was seen in 78% of PL8177-treated patients versus 33% of those on placebo. Furthermore, symptomatic remission occurred in 56% of patients on PL8177 as opposed to 33% in the placebo group. The treatment exhibited excellent safety and tolerability, with no adverse events reported.

The study involved a small cohort of 12 patients, divided into nine receiving PL8177 and three on placebo. These patients were observed over an eight-week period. The trial employed a randomized, double-blind, placebo-controlled design. While initially designed to include up to 28 participants, only 12 were enrolled due to strategic shifts in Palatin's focus, aiming to expedite licensing discussions and channel resources towards its obesity treatment pipeline.

Dr. Carl Spana, President and CEO of Palatin, expressed enthusiasm about the results, highlighting the potential of PL8177 as a safer and effective alternative to traditional immunosuppressive and steroid treatments. These conventional therapies often carry significant safety issues. In contrast, PL8177 operates through MC1R agonism, a novel mechanism that might offer a new treatment pathway for UC patients.

The trial also demonstrated improvements in a subset of patients with moderate disease, defined by inflammation across all three colon segments. Among these, 60% of PL8177-treated patients showed improvement in all segments, compared to none in the placebo group.

Dr. Dana J. Lukin from Weill Cornell Medicine emphasized the persistent need for innovative UC treatments, noting the positive outcomes from the trial as a significant indicator of the potential for MC1R agonists in managing UC. Dr. Spana echoed this sentiment, pointing out the strong interest from major pharmaceutical companies in Palatin's UC program, driven by the robust efficacy data from this Phase 2 study.

PL8177's design targets melanocortin-1 receptors located on colon epithelial cells, with previous Phase 1 trials confirming its ability to reach the colon effectively without systemic absorption. This characteristic minimizes the risk of broader systemic side effects, making it a promising candidate for UC treatment. Additionally, earlier studies suggested that PL8177 could enhance colon health by increasing vital cell populations and modulating immune responses to reduce inflammation.

Ulcerative colitis is a chronic inflammatory bowel disease that severely impacts patients' quality of life, causing symptoms like abdominal pain, diarrhea, and urgency. Current treatments are not effective for a significant number of patients, particularly those with moderate-to-severe forms of the disease.

Palatin, through its innovative work with the melanocortin receptor system, continues to develop targeted therapies for diseases with substantial unmet medical needs. The positive results from the PL8177 trial not only bolster the potential for this treatment but also pave the way for future collaborations with larger pharmaceutical entities to bring effective solutions to patients suffering from ulcerative colitis.