Palatin Stock Drops As Co-Primary Sign, Secondary Sign Endpoints Not Met In PL9643 Phase 3 DED Trial

(RTTNews) - Palatin Technologies, Inc.'s (PTN) shares were losing more than 38 percent in pre-market activity on the NYSE after the biopharmaceutical company announced that co-primary sign endpoint and secondary sign endpoints in its PL9643 MELODY-1 pivotal Phase 3 clinical trial in dry eye disease did not achieve statistical significance.

In pre-market activity on the NYSE, Palatin shares were losing around 38.8 percent to trade at $2.43.

Meanwhile, PL9643 treatment was clinically meaningful and statistically significantly effective in reducing patient symptoms for the co-primary pain endpoint and multiple other symptom endpoints.

The company said its comprehensive data analysis is ongoing, and upon completion, it plans to meet with the FDA to discuss and get feedback on the design of the next pivotal Phase 3 clinical trial.

The company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system said its MELODY-1 pivotal Phase 3 clinical trial evaluated the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease or DED.

Dry eye disease is a common inflammatory disease, and if left untreated, it can become extremely painful and lead to permanent damage to the cornea and vision.

In the statement, the company noted that MELODY-1 trial had two co-primary efficacy endpoints. These were one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining), along with multiple other symptom and sign secondary endpoints of DED.

After adjusting the Intent-to-Treat or ITT analysis for age and gender, PL9643 treatment demonstrated clinically meaningful and statistically significant results for the co-primary symptom endpoint of pain and multiple other symptom endpoints.

Further, PL9643 treatment for the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population but did not achieve statistical significance.

In the unadjusted planned analyses, the co-primary endpoints and secondary endpoints did not reach statistical significance.

Carl Spana, President and CEO of Palatin, said, "It is important to note that it is rare for one clinical study in DED to show efficacy for both a sign and a symptom. While additional analyses are ongoing, the initial results reinforce the potential of PL9643 as a treatment to address both symptoms and signs of DED."

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