Palatin Technologies Inc. (NYSE: PTN) has announced the start of a pivotal Phase 3 MELODY-1 clinical trial of PL9643 in dry eye disease patients. The study seeks to enroll around 400 patients across several sites in the US, with topline results expected in 2H 2022.
Palatin commences MELODY-1 study
The company’s CEO and President Carl Spana stated, “We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease. This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin’s expertise and efficiency in melanocortin peptide development for indications with unmet medical need.”
The pivotal third Phase MELODY-1 clinical trial compares the efficacy and safety of the melanocortin agonist, PL9643 ocular solution, to vehicle in participants with dry eye condition (DED). The Phase 2 study results for PL9643 in the treatment of dry eye disease supports the current study design, as well as an end-of-phase 2 (EOP2) meeting with the FDA, where all key elements of a pivotal Phase 3 clinical program, including study design, interim assessment, endpoints, and patient population, were agreed upon.
A second phase 3 study (MELODY-2) and a long-term safety study (MELODY-3) will also be necessary to support a New Drug Application (NDA) submission. If all goes according to plan, topline MELODY-1 results will be available in the second half of the calendar year 2022, MELODY-2 data will be read out in the second half of the calendar year 2023, and an NDA filing might happen in the first part of the calendar year 2024.
PL9643 could offer a potential dry eye disease treatment
Chief Medical Officer Michael Raizman stated, Progressing PL9643 into Phase 3 is a significant milestone for the company and patients with DED. PL9643, with its differentiating factors, could provide a more tolerable and effective treatment option for patients suffering from dry eye disease.”
There are five different types of melanocortin receptors. The use of receptor-specific agonists, which stimulate receptor function, or receptor-specific antagonists, that inhibit receptor function, therefore having therapeutically relevant pharmacological effects on these receptors.
