Palatin Technologies Touts Positive Results From Mid-Stage Study For Experimental Drug For Ulcerative Colitis, Halts Patients Enrollment Citing Strategic Focus

Palatin Technologies Inc. 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:

• The company said clinical remission was achieved in 33% (3 of 9) of PL8177-treated patients versus 0% (0 of 3) on placebo.
• Clinical response (statistically significant) was demonstrated in 78% (7 of 9) of PL8177-treated patients versus 33% (1 of 3) on placebo.
• Symptomatic remission was achieved in 56% (5 of 9) of PL8177-treated patients versus 33% (1 of 3) on placebo.
• Results for a subset of patients with more moderate disease at baseline showed that three of five (60%) PL8177-treated patients showed improvement in all three segments.
  • Four of five (80%) PL8177-treated patients showed improvement in two of the three segments.
  • Zero of one (0%) placebo patients showed improvement in two or more segments.

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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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