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Completion of Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis
Palatin Technologies (NYSE American: PTN)* is on a remarkable winning streak, reporting positive clinical results across three major diseases in just the past two weeks. The company's latest victory came today with promising data in diabetic kidney disease presented at the National Kidney Foundation Spring Meeting in Boston.
"The positive results from our Phase 2b study evaluating a melanocortin agonist in patients with diabetic Type 2 nephropathy represents our third major clinical milestone across distinct therapeutic areas," said Carl Spana, Ph.D., President and CEO of Palatin. "These results, along with previously announced positive topline data from our Phase 2 obesity and ulcerative colitis studies, and the advancement of our Phase 3 dry eye disease program, demonstrate the breadth and robustness of our melanocortin platform."
In the six-month BREAKOUT study, patients with Type 2 diabetic nephropathy showed significant improvements in kidney function after treatment with bremelanotide, a melanocortin agonist. Seventy-one percent of patients achieved meaningful reductions in protein levels in urine and maintained or improved their glomerular filtration rate—both critical markers of kidney health.
This latest success caps an impressive series of announcements. On March 31, Palatin reported that its Phase 2 obesity study met its primary endpoint with highly statistically significant results. The co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001). Notably, the company's MC4R agonist appeared to prevent weight regain after tirzepatide discontinuation, potentially addressing one of the biggest challenges in obesity treatment.
"This study provides compelling evidence that combining an MC4R agonist with a GLP-1/GIP compound creates a synergistic effect on weight loss," said Jesse Richards, DO, of Oklahoma State University College of Osteopathic Medicine, as quoted in Palatin's press release. "With a critical need for diverse weight loss solutions, this approach offers a promising improvement to GLP-1/GIP monotherapy, particularly for those who struggle with tolerability at high doses."
Just days earlier, Palatin announced breakthrough results in ulcerative colitis. Their PL8177 treatment demonstrated clinical response in 78% of treated patients versus 33% on placebo (p<0.005), with clinical remission achieved in 33% of PL8177-treated patients versus 0% on placebo.
"We are thrilled with the positive results in this study, especially the meaningful and high rates of achievement for clinical remission and clinical response," Dr. Spana stated in the announcement. "These endpoints align with the FDA's recommended primary and key secondary endpoints for evaluating efficacy in UC clinical trials."
The potential market impact of these developments is substantial. Palatin's approach to obesity treatment appears particularly timely as Rhythm Pharmaceuticals just reported successful Phase 3 results for setmelanotide in hypothalamic obesity, showing a -19.8% placebo-adjusted BMI reduction. The two companies represent the only players actively developing MC4R-targeted therapies for obesity conditions.
Adding to Palatin's momentum, the FDA recently granted "orphan drug" designation to PL7737, the company's oral melanocortin-4 receptor agonist, for leptin receptor deficiency obesity. This designation provides incentives including tax credits for clinical trials and potential market exclusivity.
According to Dr. Spana, the company is advancing discussions with multiple pharmaceutical companies for potential licensing deals. "Several major pharmaceutical companies have shown strong interest in our UC program," he stated in the March 28 press release, "and we believe these positive Phase 2 results in PL8177 treated patients, for the critical efficacy endpoints of both clinical remission and clinical response, could help solidify a potential licensing deal."
With multiple clinical successes driving interest in its technology platform across billion-dollar markets including obesity, ulcerative colitis, and kidney disease, Palatin appears to be validating its scientific approach as analysts at H.C. Wainwright maintain a $7 price target on the stock.
Recent Palatin Technologies News Highlights:
Completion of Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide
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