Okyo announced on Monday that it is now focused on advancing to a multiple-ascending-dose clinical trial, designed to enroll approximately 100 patients with neuropathic corneal pain across several U.S. clinical sites.
Shares of OKYO Pharma (OKYO) jumped 8% on Monday morning after the company said that it is now planning to advance to a multiple-ascending-dose (MAD) clinical trial for its lead drug candidate Urcosimod.
Urcosimod is being developed to treat neuropathic corneal pain (NCP), a condition that causes severe pain and sensitivity of the eyes, face, or head, and is thought to result from nerve damage to the cornea combined with inflammation.
In July, the company announced data from a mid-stage trial of Urcosimod in 17 NCP patients. After 12 weeks of treatment, 75% of per-protocol patients receiving 0.05% Urcosimod showed greater than 80% reduction in neuropathic corneal pain in that study, as measured by visual analog scale.
Okyo said on Monday that it is now focused on advancing to a multiple-ascending-dose (MAD) clinical trial designed to enroll approximately 100 NCP patients across several U.S. clinical sites. The purpose of the trial is to identify the optimal registration dose for Urcosimod for future late-stage trials and to develop an understanding of the drug’s characteristics.
On Stocktwits, retail sentiment around OKYO stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user opined that they now see a “clear route forward.”
The company said that it expects data from this new trial in 2026, and negotiations are underway with several clinical sites in the U.S. Okyo continues to progress toward a meeting with the U.S. Food and Drug Administration (FDA) to discuss requirements for an approvable drug to treat NCP and to define the primary endpoint required for potential registration, it said.
“Our next MAD clinical trial is designed to give us the data needed to define an optimal registration pathway for urcosimod, and we are moving rapidly to initiate this study. With Fast-Track designation in place and a constructive engagement anticipated with FDA, we are well-positioned to bring this novel therapy closer to patients in need,” said CEO Gary S Jacob.
OKYO stock is up 85% this year and approximately 112% over the past 12 months.
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