Palatin Presents Positive Phase 3 PL9643 MELODY-1 DED Clinical Results at ASCRS 2024

Palatin Technologies, Inc., a biopharmaceutical firm, has reported promising results from its Phase 3 PL9643 MELODY-1 clinical trial for dry eye disease (DED). The study, which was presented at the American Society of Cataract and Refractive Surgery (ASCRS), showcased the effectiveness and safety of PL9643 compared to a placebo.

Dr. Eric Donnenfeld highlighted the trial's findings, emphasizing that the ITT PL9643 group showed significant improvements in pain, a primary symptom endpoint, and seven out of eleven secondary symptom endpoints after a 12-week treatment period. Notably, the drug demonstrated rapid efficacy, with multiple symptom and sign endpoints, including the primary pain endpoint, reaching statistical significance as early as two weeks into treatment.

Palatin's CEO, Carl Spana, Ph.D., noted that the drug's rapid and sustained efficacy, along with its safety profile, positions PL9643 as a differentiated product in the DED treatment landscape. He also mentioned that discussions with potential partners and preparations for a meeting with the FDA are underway to discuss further studies required for a New Drug Application (NDA) submission.

The Phase 3 MELODY-1 trial was a randomized, double-masked, and vehicle-controlled study involving 575 patients in the U.S., evaluating PL9643's safety and efficacy for 12 weeks in patients with moderate-to-severe DED. The study was designed following positive Phase 2 results and guidance from the FDA.

DED is a prevalent condition affecting an estimated 38 million people in the U.S., with a significant number remaining undiagnosed or untreated. The condition can lead to severe discomfort and, if left untreated, permanent vision damage. The current market for DED treatments is substantial and expected to grow, reflecting an urgent need for effective and safe therapies.

Palatin focuses on developing first-in-class medicines that modulate the melanocortin receptor system, targeting diseases with significant unmet needs. The melanocortin system plays a crucial role in various physiological processes, including inflammation and immune responses, offering a promising avenue for treating DED.

The company's strategy involves developing innovative products and partnering with industry leaders to maximize commercial potential. With the positive results from the MELODY-1 trial, Palatin is well-positioned to address the unmet needs of DED patients and contribute to the growing market for effective treatments.

In summary, Palatin's PL9643 has demonstrated efficacy and safety in treating DED, with rapid symptom improvement and a favorable safety profile. The company is actively engaging with regulatory bodies and potential partners to advance the drug's development and commercialization.