OKYO Pharma (NASDAQ:OKYO) stock jumped 14% Wednesday after announcing encouraging Phase 2 clinical trial results for urcosimod, their investigational drug aimed at neuropathic corneal pain (NCP).
The ophthalmology-focused biotech reported that 75% of patients treated with 0.05% urcosimod per protocol experienced over an 80% reduction in pain after 12 weeks. Efficacy was observed as early as Week 4, with pain relief sustained throughout the study.
This randomized, double-blind, placebo-controlled trial demonstrated a statistically significant drop in average pain scores from baseline to the study’s end in the urcosimod group (p = 0.025). Patients receiving the drug saw a mean pain decrease of 5.5 points versus 2.75 points for those on placebo.
Importantly, all responders started the trial with moderate to severe pain despite prior maximal medical treatment. No serious adverse events were reported among the 18 participants.
“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, CEO 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 engage with the FDA on next steps for urcosimod, which already holds Fast Track status for NCP — a condition lacking any FDA-approved therapies.
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