OKYO Pharma speeds up NCP drug development

LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical company focusing on ophthalmic diseases with a current market capitalization of $54 million, has announced the early completion of its Phase 2 trial for urcosimod, a drug candidate aimed at treating Neuropathic Corneal Pain (NCP). The company’s stock has shown remarkable momentum, gaining over 34% in the past six months, according to InvestingPro data. The trial, which took place at Tufts Medical Center in Boston, MA, concluded with 17 patients having completed the study, earlier than initially planned.

The company’s decision to end the trial at this stage is driven by the intention to analyze the masked data sooner and to expedite the drug’s development process. While InvestingPro data shows the company currently operates with short-term obligations exceeding liquid assets, with a current ratio of 0.28, the participants’ strong interest in the trial has led OKYO Pharma to consider a larger multicenter trial for urcosimod. The company maintains a moderate debt level, which could support future development plans.

Some patients who completed the trial have requested continued access to urcosimod under compassionate use, which the company is arranging with Tufts Medical Center, pending necessary FDA approvals. The analysis of the trial data is expected to be concluded within six weeks, which will then enable OKYO Pharma to request a meeting with the FDA to discuss the next steps in urcosimod’s clinical development.

Urcosimod has previously demonstrated favorable safety and placebo-like tolerability in a 240 patient Phase 2 trial for dry eye disease. By closing the NCP trial early, OKYO Pharma aims to reduce the time required to progress to an end-of-phase 2 meeting with the FDA.

NCP is a debilitating condition characterized by severe pain and sensitivity of the eyes, face, or head, often due to nerve damage and inflammation of the cornea. Currently, there is no FDA-approved treatment for NCP, and patients rely on various off-label topical and systemic treatments.

Urcosimod, initially known as OK-101, is a lipid conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor found on immune and neuronal cells. It was designed for increased ocular retention to enhance its therapeutic potential.

OKYO Pharma, listed on the NASDAQ Capital Market, is dedicated to developing novel treatments for neuropathic corneal pain and dry eye disease. The company’s progress with urcosimod represents a significant step in addressing the unmet medical needs of NCP sufferers. Analysts maintain a bullish outlook with a $7 price target, suggesting significant upside potential. InvestingPro subscribers have access to over 10 additional key insights about OKYO’s financial health, market performance, and growth prospects. The information for this article is based on a press release statement and InvestingPro data.

In other recent news, OKYO Pharma Limited has announced that its drug candidate, urcosimod, has demonstrated stability for over two and a half years in single-use ampoules, a critical factor for its potential market release. Urcosimod is currently undergoing a Phase 2b clinical trial aimed at treating neuropathic corneal pain, a condition that currently lacks FDA-approved therapies. The company has also applied for Fast Track designation from the U.S. Food and Drug Administration, which could expedite the review process for this investigational drug. The Fast Track program is intended for drugs that address serious conditions with unmet medical needs, potentially allowing for more frequent communications with the FDA and a rolling review process. Analyst firm H.C. Wainwright has maintained a Buy rating on OKYO Pharma, highlighting the drug’s unique properties and recent clinical progress. Urcosimod has shown promise in earlier trials for dry eye disease, demonstrating significant improvements in symptoms such as stinging and burning. These developments underscore OKYO Pharma’s commitment to advancing treatments for ocular conditions, with the stability of urcosimod strengthening its candidacy for FDA approval. Investors and patients alike are watching closely as the company progresses through clinical trials and regulatory processes.

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