Palatin reports ‘positive’ results from Phase 2 study of PL8177

Palatin (PTN) Technologies announced positive topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor agonist, in patients with active ulcerative colitis. This study was designed to assess the safety, tolerability, and effectiveness of PL8177 when taken orally by adults with active UC. Key findings after eight weeks of treatment are summarized below: Clinical Remission: Achieved in 33% of PL8177-treated patients versus 0% on placebo after eight weeks of treatment. Clinical Response (statistically significant): Demonstrated in 78% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment. Symptomatic Remission: Achieved in 56% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment. Safety and Tolerability: Excellent, with no adverse events. Licensing: Discussions advancing with multiple big pharma companies. “We are thrilled with the positive results in this study, especially the meaningful and high rates of achievement for clinical remission and clinical response. These endpoints align with the FDA’s recommended primary and key secondary endpoints for evaluating efficacy in UC clinical trials,” stated Carl Spana, Ph.D., President and CEO of Palatin. “Most patients showed significant symptom and endoscopic score improvements after just eight weeks of treatment. This study evaluated a novel mechanism of action, MC1R agonism, as a potential treatment for UC. Given these positive results, once-daily oral PL8177 could be a safe and effective alternative to immunosuppressive and steroid therapies, which have significant safety and tolerability concerns.”