CRANBURY - Palatin Technologies, Inc., a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced financial results for its fiscal third quarter ended March 31, 2024.

'Study results of our successful Phase 3 MELODY-1 clinical trial for DED demonstrate that PL9643, with its early onset of efficacy for multiple symptoms and signs of dry eye disease and the excellent ocular safety and tolerability profile, has the potential to be a highly differentiated product,' said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. 'The efficacy results were statistically significant for the co-primary symptom endpoint of pain and 7 of 11 exploratory secondary endpoints, including eye dryness, as early as two weeks, which was the first time point measured. We are advancing discussions with potential collaboration partners and actively preparing for a meeting with the FDA later this year to discuss the remaining studies for the PL9643 program required to support an NDA submission.'

Dr. Spana further commented, 'We are excited to launch two new therapeutic area clinical trials in the second quarter of calendar year 2024, with topline data readouts in the second half of calendar year 2024. The first is a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients. The second is a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i, for the treatment of erectile dysfunction in patients that do not respond to PDE5i monotherapy.'

Fiscal Third Quarter Ended March 31, 2024 Business Highlights and Recent Updates

Anti-Inflammatory / Autoimmune Programs (melanocortin receptor agonists)

Phase 3 PL9643 for the treatment of dry eye disease (DED): Successful Phase 3 MELODY-1 pivotal study completed

Co-primary symptom endpoint of pain met statistical significance (P

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