Shares in biopharmaceutical company, Palatin Technologies, suffered a significant loss in NYSE pre-market trading, dropping by over 38 percent. This followed an announcement that the Phase 3 clinical trial for their new treatment for dry eye disease, PL9643, failed to achieve its co-primary endpoint and secondary endpoints. Despite this, some notable treatment effects were observed, reducing patient symptoms for the primary pain endpoint and other symptom endpoints.
Expanding on the details, the MELODY-1 clinical trial, designed to evaluate the efficacy and safety of PL9643, demonstrated clinically significant results after adjusting for factors such as patient age and gender. However, planned analyses showed that primary and secondary endpoints did not reach statistical significance.
Clearly, the results have sparked a reaction on the stock market, with Palatin shares trading at $2.43, reflecting a loss of almost 39 percent. Despite the setback, Palatin remains optimistic about the potential of PL9643 as a dry eye treatment. The company's President and CEO, Carl Spana, explained that it's unusual for one clinical study to show efficacy for both sign and symptom in dry eye disease.
Dry eye disease is a common inflammatory condition. Without treatment, it can be extremely painful and potentially cause permanent corneal damage and vision problems. The endpoints for the MELODY-1 trial were based on the clinical symptoms of pain and evidence of a sign (conjunctival lissamine green staining), alongside secondary symptom and sign endpoints.
As Spana concluded, "the initial results reinforce the potential of PL9643 to address both symptoms and signs of dry eye disease." As the company continues with its comprehensive data analysis, plans are being made to meet with the FDA to discuss feedback on future Phase 3 clinical trial designs.
