Palatin’s PL8177 shows promise in ulcerative colitis study

CRANBURY, N.J. - Palatin Technologies, Inc. (NYSE American: PTN), a small-cap biotech company with a market capitalization of $18.2 million, has announced encouraging results from its Phase 2 trial of PL8177, a drug targeting ulcerative colitis (UC). The study, focusing on safety, tolerability, and efficacy, showed that 33% of patients treated with PL8177 achieved clinical remission compared to none on placebo after eight weeks. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn.

Clinical response, a key measure of treatment effect, was seen in 78% of patients receiving PL8177 versus 33% on placebo. Symptomatic remission was also higher in the treatment group, with 56% achieving this outcome compared to 33% for placebo.

The trial was a randomized, placebo-controlled study involving twelve patients with active UC. The study’s findings are promising, particularly as no treatment-related adverse events were reported, suggesting that PL8177 is well tolerated.

Dr. Carl Spana, President and CEO of Palatin, expressed optimism about the drug’s potential as an alternative to current UC treatments, which can have significant safety concerns. The company is now in discussions with several major pharmaceutical companies regarding licensing.

The trial’s positive outcomes are based on a novel mechanism of action involving melanocortin-1 receptor agonism. This approach could offer a new avenue for UC treatment, a chronic disease affecting the colon and causing symptoms that can severely impact quality of life.

Palatin halted enrollment at twelve patients to expedite out-licensing discussions and focus on developing its melanocortin obesity assets. Despite the small sample size, the strong response rates for clinical remission and clinical response are seen as significant.

Further details on the trial are expected to be shared at an upcoming scientific conference. The drug’s development builds on previous research and Phase 1 findings, suggesting that orally administered PL8177 can reach the colon effectively without systemic absorption.

The company continues to explore the potential of melanocortin receptor agonists for diseases with unmet medical needs, aiming to partner with industry leaders to maximize commercial potential. This news is based on a press release statement from Palatin Technologies.

In other recent news, Palatin Technologies reported its Q2 FY2025 earnings, revealing an earnings per share (EPS) of -0.12, significantly outperforming the forecasted -0.51. Despite reporting zero revenue for the quarter, the company’s financial position showed improvement with a reduced net cash usage in operations, down to $4.8 million from $10.5 million the previous year. Additionally, Palatin’s net loss improved to $2.4 million from $7.8 million in the same period last year. The company raised an additional $4.3 million through an equity offering, contributing to its cash reserves. In another development, Palatin received orphan drug designation from the FDA for its investigational treatment, PL7737, targeting LEPR deficiency obesity. This designation provides incentives like tax credits and market exclusivity, supporting Palatin’s efforts in developing treatments for rare diseases. Analysts from H.C. Wainwright have shown interest in Palatin’s obesity study, focusing on signal detection rather than specific weight loss percentages. The company is also advancing its obesity treatment programs, with plans to initiate a Phase 1 study for hypothalamic obesity by late 2025.

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