Palatin Technologies Inc PTN shares are trading lower after the company released results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle for dry eye disease (DED).
MELODY-1 had two co-primary efficacy endpoints: one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining) and multiple other symptom and sign secondary endpoints of DED.
After adjusting the Intent-to-Treat (ITT) analysis for age and gender, PL9643 treatment demonstrated clinically meaningful (visual analog score reduction of >10 points from baseline) and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints.
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 and secondary endpoints did not reach statistical significance.
“Even with a high vehicle response, PL9643 treatment was clinically meaningful and statistically significantly effective on an ITT basis in reducing patient symptoms for the co-primary pain endpoint and multiple other symptom endpoints,” said Carl Spana, President and CEO.
“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 symptoms and signs of DED,” added Spana.
Safety analysis indicated PL9643 was well-tolerated. There were fewer ocular treatment-related adverse events in the PL9643 arm (5.6%, N=16/288) compared to the vehicle (6.3%, N=18/287) and fewer study discontinuations in the PL9643 arm (7.0%, N=20/288) compared to vehicle (11.1%, N=32/287).
While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product.
Price Action: PTN shares are down 36.3% at $2.53 on the last check Wednesday.
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