Palatin Technologies Inc. (NYSE:PTN) on Friday released topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, in patients with active ulcerative colitis.
The Phase 2 randomized, placebo-controlled study evaluated 12 patients (nine in the PL8177 arm and three in the placebo arm) with active ulcerative colitis for eight weeks of treatment:
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Treatment with oral PL8177 was well tolerated, and no treatment-related side effects were reported.
The study originally planned to enroll up to 28 patients, with an interim analysis after 12-16 participants. Due to a shift in strategic focus, Palatin stopped enrollment at 12 patients to accelerate out-licensing discussions and redirect resources to developing its melanocortin obesity assets.
As a result of lower patient numbers, the study was not powered to show statistical significance.
On Tuesday, the U.S. Food & Drug Administration granted orphan drug designation to Palatin Technologies’ PL7737, an oral treatment that activates the melanocortin-4 receptor, for leptin receptor deficiency, including obesity caused by this condition.
Price Action: PTN stock is down 2.43% at $0.68 during the premarket session at the last check Friday.
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