A third of patients with active ulcerative colitis (UC) experienced clinical remission in a Phase II trial of Palatin Technologies’ melanocortin-1 receptor (MC1R) agonist, PL8177.
The company’s randomised parallel assignment trial (NCT05466890) saw 33% of patients dosed with PL8177 achieving clinical remission while the placebo group saw none. At the same time, 78% of patients dosed with the company’s oral therapy saw clinical response, versus 33% in the placebo group after eight weeks of treatment, which Palatin says is statistically significant.
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Despite this data, the company’s stock, listed on the New York Stock Exchange (NYSE) has dropped by 7.83% today (28 March), from a market close of $0.70 yesterday to $0.64 (correct at 11:45am EDT).
The triple-masked trial recruited 12 patients, who were dosing nine with PL8177 and the rest with placebo, once daily over eight weeks. The study originally intended to recruit 28 patients.
From the patients dosed with the company’s therapeutic, 56% saw symptomatic remission while only 33% of placebo patients reached the same. In this instance, symptomatic remission was defined as a score of zero or one using the Mayo stool frequency subscore (SFS) and Mayo rectal bleeding subscore (RBS) of zero.
Palatin Technologies CEO Carl Spana said: “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 US Food and Drug Administration’s (FDA) recommended primary and key secondary endpoints for evaluating efficacy in UC clinical trials.
“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.”
The US National Institute of Health (NIH) estimates that across the US there are between 600,000 and 900,000 people living with UC in which abnormal reactions from the immune system cause inflammation and ulcers on the inner lining of the large intestine.
Spana added: “The strong data from this Phase II study, along with the positive Phase I findings and robust preclinical data, provides meaningful evidence to support the advancement of a melanocortin-1 receptor agonist as a potential treatment for ulcerative colitis.
“Several major pharmaceutical companies have shown strong interest in our UC programme, and we believe these positive Phase II results in PL8177 treated patients, for the critical efficacy endpoints of both clinical remission and clinical response, could help solidify a potential licensing deal.”
Research by GlobalData’s Pharmaceutical Intelligence Center reveals that the global market for UC therapies brought in more than $7bn in 2024 and is set to rise to more than $15bn by the end of the decade. The space is largely dominated by Takeda Pharmaceutical’s Entyvio (vedolizumab), which brought in more than $6.4bn last year alone, accounting for a significant majority of the market.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the UC market, Johnson & Johnson (J&J) and Protagonist Therapeutics’s joint interleukin-23 (IL-23) inhibitor, icotrokinra, has met the primary endpoint in a Phase IIb study. Meanwhile, OSE Immunotherapeutics’ Phase II CoTikiS study of lusvertikimab has met primary and secondary endpoints, showing high rates of clinical and endoscopic remission after ten weeks.
