Palatin provides update from pivotal Phase 3 MELODY-1 clinical trial

Palatin (PTN) Technologies announced updated results from responder analyses of its pivotal Phase 3 MELODY-1 clinical trial evaluating the safety and efficacy of PL9643 versus placebo in the treatment of dry eye disease, or DED. The updated findings further strengthen PL9643’s clinical profile, highlighting its potential to address a critical unmet need in DED by achieving statistically significant complete symptom resolution across multiple symptom endpoints – a level of improvement not seen with any currently approved DED therapies. Key findings include: Responder analysis was conducted to evaluate the percentage of patients achieving complete symptom clearing across 13 pre-specified symptom endpoints. Separately, the Symptom Composite Score, based on seven Visual Analog Scale, or VAS, symptom ratings, was used to quantify overall symptom burden from the patient’s perspective. This score averages individual VAS ratings to provide a comprehensive assessment of symptom improvement. The detailed analyses have been accepted for presentation at an upcoming medical conference. Statistically Significant Symptom Clearing after 12 Weeks: In 6 of the 13 symptom endpoints, a significantly higher percentage of patients treated with PL9643 achieved complete symptom resolution compared to placebo at 12 weeks. This level of symptom clearing has not been achieved by any FDA-approved dry eye therapies to date. Early and Sustained Symptom Resolution: The Symptom Composite Score for PL9643-treated patients showed statistically significant symptom resolution at two weeks, with continued improvement through 12 weeks and no signs of plateau. In contrast, the placebo group showed minimal improvement that quickly plateaued. FDA approval guidance for dry eye drug development supports the use of responder analyses to demonstrate symptom improvement, requiring a statistically significant difference in the proportion of patients achieving complete symptom resolution – a key criterion met by PL9643. The remaining Phase 3 clinical program consists of two studies, MELODY-2 and MELODY-3, each evaluating both sign and symptom endpoints. Subject to securing a collaboration and funding, patient enrollment could begin in the second half of this year, with topline data in the second half of next year.