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LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical firm with a market capitalization of $45.8 million, announced the successful long-term stability of its drug candidate urcosimod, designed to treat neuropathic corneal pain (NCP). The company’s stock has shown strong momentum, gaining over 32% in the past six months, according to InvestingPro data. Results from Good Manufacturing Practice (GMP) stability assay testing indicated that urcosimod remains stable for over two and a half years when stored in refrigerated single-use ampoules.
This stability is a critical step in meeting the requirements for a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). Urcosimod is currently undergoing a Phase 2b, randomized, placebo-controlled, double-masked trial with 48 patients aimed at treating NCP, a condition without an FDA-approved therapy.
The trial, which involves a 12-week treatment period, is being conducted at Tufts Medical Center under the leadership of Dr. Pedram Hamrah. NCP is a severe eye condition that causes pain and sensitivity, often resulting from nerve damage and inflammation.
Urcosimod, previously known as OK-101, is a lipid conjugated chemerin peptide agonist targeting the ChemR23 receptor. It has demonstrated anti-inflammatory and pain-reducing activities in mouse models. The drug’s design includes a lipid anchor to potentially enhance its residence time within the ocular environment, addressing concerns about the rapid washout seen with other treatments.
The use of single-use ampoules for ophthalmic drugs is increasingly popular, offering ease of use and reducing the risk of contamination associated with multi-use bottles. OKYO Pharma’s recent findings also highlight urcosimod’s stability at room temperature, with three-month results showing stability at or above 100%.
These developments follow a completed Phase 2 trial for dry eye disease, where urcosimod showed significant efficacy across multiple endpoints. The current focus is on its potential to address NCP, with the ongoing trial serving as a pivotal evaluation for its effectiveness in treating this debilitating condition. While the company currently operates at a negative EBITDA of $10.35 million, analysts maintain an optimistic outlook with a price target of $7 per share. InvestingPro subscribers can access additional insights, including 5 more exclusive ProTips and comprehensive financial metrics.
OKYO Pharma’s commitment to developing treatments for ocular conditions like NCP and dry eye disease is underscored by this latest advancement, which is based on a press release statement from the company. As the trial progresses, the stability of urcosimod strengthens its candidacy for potential FDA approval and subsequent patient use. Trading near $1.35, InvestingPro analysis suggests the stock may be slightly undervalued, with a Fair overall financial health rating despite current pre-revenue status.
In other recent news, OKYO Pharma Ltd announced that its drug candidate, urcosimod, has demonstrated stability for over two and a half years in single-use ampoules, which is crucial for its administration to patients. The drug is currently in a Phase 2b clinical trial aimed at treating Non-Cancer Pain (NCP) patients. Additionally, OKYO Pharma has applied for Fast Track designation from the U.S. Food and Drug Administration (FDA) for urcosimod, which is intended to treat neuropathic corneal pain, a condition lacking FDA-approved treatments. The Fast Track program could expedite the drug’s review process, potentially leading to quicker availability for patients. H.C. Wainwright has maintained a Buy rating on OKYO Pharma, with a price target of $7.00, reflecting confidence in urcosimod’s potential. The drug has shown promising results in previous trials for dry eye disease, demonstrating significant pain reduction and a favorable safety profile. OKYO Pharma recently announced the official naming of its lead drug candidate, OK-101, as urcosimod, which was granted by the United States Adopted Name (USAN) Council. The company continues to focus on developing therapies for ocular conditions, with urcosimod undergoing a Phase 2 clinical trial for neuropathic corneal pain, with results expected in the fourth quarter of 2025.
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