Recent Updates
Recently added Catalysts
OKYO Positive Sentiment Score: 75/100

OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain Urcosimod phase 2 trial treating Neuropathic Corneal Pain ("NCP") patients was initiated in October 2024 a

Key Takeaway: OKYO Pharma has announced plans to expedite the clinical development of Urcosimod to treat Neuropathic Corneal Pain (NCP) following the early closure of its phase 2 trial. The trial, conducted at Tufts Medical Center, involved 17 patients suffering from chronic pain, and the decision to close it was driven by a desire to quickly access data for planning further studies. Despite the early closure, the company is experiencing strong interest from potential future trial participants and aims to meet with the FDA to discuss the next steps for Urcosimod's development.

Market Sentiment Analysis

POSITIVE FACTORS

  • OKYO Pharma is accelerating the clinical development of Urcosimod, indicating strong progress.
  • The phase 2 trial showed favorable safety and tolerability in a previous study.
  • There is significant interest in participating in future trials from potential patients.

CONCERNS & RISKS

  • The trial was closed early, which could indicate challenges in data collection.
  • Only 17 patients completed the study, which may limit the robustness of the findings.

Full Press Release Details

Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain
Urcosimod phase 2 trial treating Neuropathic Corneal Pain ("NCP") patients was initiated in October 2024 and designed as a double-masked, randomized, 12-week placebo-controlled trial.
OKYO Pharma plans to analyze the efficacy data from the 17 patients who have now completed the Phase 2 trial.
OKYO Pharma plans for a meeting with FDA following evaluation of clinical data.
and New York, NY, April 30, 2025. OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing
urcosimod (formerly called OK-101) to treat NCP, an ocular condition associated with chronic and
often severe pain but without an FDA-approved therapy, announces plans to accelerate the clinical development of urcosimod to
treat NCP through the analysis of its data following the early closure of its Phase 2 trial.
Phase 2 trial of urcosimod to treat NCP was being conducted at a single trial site at Tufts Medical Center in Boston, MA. The decision
to close the trial now, with 17 patients having presently completed the study, is due to OKYO's strong desire to access the currently
masked data and use it to plan its expanded development program. The patients participating in the trial have all been diagnosed with
long term chronic neuropathic corneal pain and had previously been treated with multiple therapies with very limited or no response.
Significant interest has been seen in the trial from long-term sufferers of NCP, and OKYO believes it should expand the development program
and move forward with a multicenter trial. A considerable number of potential patients have expressed an interest in participating in
a future registrational trial.
number of patients who have now completed the trial have requested continued compassionate use of urcosimod which the Company is seeking
to arrange with Tufts Medical Center, subject to the necessary FDA consents.
ending this trial now, we believe we can save time in advancing the program to a meeting with FDA to discuss further development of urcosimod,"
commented Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. "We anticipate that the analysis of the data from these
patients with the closing of this trial should take no longer than 6 weeks. Urcosimod has already demonstrated favorable safety and
placebo-like tolerability in our previous 240 patient Phase 2 trial. The decision to close the trial now significantly cuts the time
to our requesting an end-of-phase 2 meeting with FDA to explore accelerated plans for the drug's further clinical development.
I want to also thank our patients and study site team for their participation and commitment to this important trial of urcosimod to
corneal pain is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause of neuropathic corneal
pain is unknown but is thought to result from nerve damage to the cornea combined with inflammation. Neuropathic corneal pain, which
can exhibit as a severe, chronic, debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated
by various topical and systemic treatments in an off-label fashion. Notably, there is no FDA approved drug to treat this debilitating
the Urcosimod Phase 2 Trial in NCP Patients
Phase 2 study was designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients. A total of 48 patients were
planned to enroll for the study, with NCP disease confirmed via confocal microscopy.
Urcosimod (Formerly called OK-101)
is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of
the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod was developed
using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. Urcosimod has
been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain,
respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to potentially
enhance the residence time of urcosimod within the ocular environment. Urcosimod showed clear statistical significance in multiple endpoints
in a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease, and was also being evaluated
in a randomized, placebo-controlled, double-masked Phase 2 trial to treat neuropathic corneal pain
Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic
corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery
and development of novel molecules to treat neuropathic corneal pain and dry eye disease. In addition to the completed Phase 2 trial
of urcosimod to treat dry eye disease patients, OKYO is also currently evaluating urcosimod to treat neuropathic corneal pain patients.
further information, please visit www.okyopharma.com.
OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer 917-497-7560
Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379

Frequently Asked Questions

What is Urcosimod being developed for?

Urcosimod is developed to treat Neuropathic Corneal Pain (NCP).

When was the Urcosimod phase 2 trial initiated?

The phase 2 trial for Urcosimod began in October 2024.

What was the design of the Phase 2 trial?

It was a double-masked, randomized, 12-week placebo-controlled trial.

How many patients completed the phase 2 trial?

Seventeen patients completed the phase 2 trial.

What is the next step for OKYO Pharma regarding Urcosimod?

OKYO Pharma plans to meet with the FDA to discuss further development.

Last updated: Apr 30, 2025