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Investing.com -- OKYO Pharma (NASDAQ:OKYO) stock jumped 14% on Wednesday after the company reported positive Phase 2 clinical trial results for urcosimod, its experimental treatment for neuropathic corneal pain (NCP).
The ophthalmology-focused biopharmaceutical company revealed that 75% of per-protocol patients receiving 0.05% urcosimod showed greater than 80% reduction in pain after 12 weeks of treatment. The drug demonstrated efficacy as early as Week 4, with sustained pain reduction throughout the trial period.
The randomized, double-masked, placebo-controlled study showed a statistically significant reduction in mean pain scores from baseline to end of treatment in the 0.05% urcosimod group (p-value = 0.025). The treatment group experienced a mean pain score reduction of 5.5 compared to 2.75 in the placebo group.
Notably, all responders in the treatment group had entered the study with moderate to severe pain despite prior maximum medical therapy. No serious adverse events were reported among the 18 patients throughout the trial.
"We are thrilled with these initial top-line results in patients treated with urcosimod from this first in-human phase 2 trial," said Gary S. Jacob, Chief Executive Officer of OKYO Pharma. "The results strengthen our conviction that this drug may be particularly effective at showing a significant reduction in pain in patients with a greater degree of neuropathic pain."
OKYO plans to meet with the FDA to discuss next steps for urcosimod, which has already received Fast Track designation for treating NCP, a condition with no currently FDA-approved therapies.
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