OKYO Pharma Reports Positive Long-Term Stability Data for Urcosimod

OKYO Pharma Limited, a biopharmaceutical company focused on innovations for treating neuropathic corneal pain (NCP) and inflammatory dry eye disease (DED), has announced promising developments concerning its drug candidate, urcosimod. Urcosimod, formerly known as OK-101, is currently undergoing a Phase 2 clinical trial for NCP, a painful eye condition with no FDA-approved treatments to date. The company revealed that urcosimod has demonstrated long-term stability, maintaining its integrity for over two and a half years in single-use ampoules. This stability is a significant milestone in meeting the FDA's requirements for drug shelf-life.

The ongoing Phase 2b trial for urcosimod involves 48 patients with NCP, assessed using confocal microscopy. The study is being conducted at Tufts Medical Center, under the guidance of Principal Investigator Dr. Pedram Hamrah. This trial is double-masked and placebo-controlled, designed to ensure unbiased results regarding the drug's efficacy and safety.

Dr. Gary S. Jacob, CEO of OKYO Pharma, emphasized the importance of not only clinical trial data but also the chemistry, manufacturing, and control (CMC) aspects crucial for FDA approval. Demonstrating long-term stability is an essential step toward a successful New Drug Application (NDA). Dr. Raj Patil, the company's Chief Scientific Officer, highlighted the robust stability results of urcosimod in ophthalmic solutions stored under refrigerated conditions, with impressive retention rates after more than two and a half years.

In addition to refrigerated stability tests, urcosimod is undergoing long-term evaluations at room temperature. Initial three-month results have shown stability levels at or above 100%, further supporting the drug’s viability. Administered as eye drops, urcosimod has exhibited favorable results in terms of comfort and efficacy, particularly in previous trials aimed at treating DED. These findings have fueled optimism about urcosimod's potential to effectively manage NCP.

The commercial landscape for ophthalmic drugs is seeing a shift toward the use of single-use ampoules. These ampoules are gaining popularity due to their ease of use and the reduced risk of contamination compared to traditional plastic bottles, which patients have used for extended periods. Single-use packaging aligns with OKYO Pharma's approach, potentially enhancing the safety and convenience of urcosimod administration.

Neuropathic corneal pain is characterized by severe eye, facial, or head pain, often resulting from corneal nerve damage coupled with inflammation. Current treatments are off-label and include various topical and systemic options. However, the absence of FDA-approved therapies underscores the urgency for effective solutions like urcosimod.

Urcosimod acts as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, found in eye immune cells, neurons, and glial cells. This receptor is implicated in inflammatory responses. The drug's design incorporates a lipid anchor, potentially extending its presence within the eye. Urcosimod has demonstrated significant anti-inflammatory and pain-relieving effects in animal models and achieved statistical significance in a Phase 2 trial for DED.

OKYO Pharma continues its commitment to pioneering treatments for NCP and DED, both substantial areas of unmet medical need. The stability findings and ongoing clinical trials represent strategic progress towards bringing a novel therapeutic option to patients suffering from these ocular conditions.