OKYO Pharma Announces Positive Data in Long-Term Stability of Urcosimod
MWN-AI** Summary
OKYO Pharma Limited (NASDAQ: OKYO) announced significant progress in its clinical development of urcosimod, a treatment for neuropathic corneal pain (NCP), a condition currently without an FDA-approved therapy. The company revealed that urcosimod has demonstrated stability in its single-use ampoules for over two and a half years, a crucial requirement for FDA approval. This long-term shelf stability reduces the risk of contamination during administration, enhancing the safety profile of the medication for patients.
Currently, urcosimod is being evaluated in a Phase 2b clinical trial involving 48 patients, where the drug's efficacy and safety are compared against a placebo. Dr. Gary S. Jacob, CEO of OKYO, emphasized that achieving long-term stability is not only vital for meeting regulatory demands but also a critical step toward filing for New Drug Application (NDA) with the FDA. Recent stability assay testing shows that urcosimod maintains its potency, with 94.8% and 97.4% of the initial concentrations intact after the storage period.
The ongoing research into urcosimod's effects on NCP patients is promising, especially given the previous positive results in treating dry eye disease, where it exhibited significant efficacy. Urcosimod works through the ChemR23 receptor, targeting inflammatory responses effectively, which is a promising development for patients suffering from chronic eye pain.
The Phase 2 study is being conducted at Tufts Medical Center and aims to confirm the effectiveness of urcosimod based on rigorous scientific methodologies, which further showcases OKYO Pharma's commitment to addressing unmet medical needs. This progress highlights OKYO's potential to introduce a much-needed therapy for NCP, reinforcing its position in the biopharmaceutical landscape.
MWN-AI** Analysis
OKYO Pharma Limited's recent announcement regarding the long-term stability of urcosimod marks a significant milestone in the company's development pipeline and presents an appealing opportunity for investors. The stability achieved in single-use ampoules for over 2.5 years not only strengthens the drug's profile but also aligns with FDA requirements for approval, making it a critical factor for the potential success of their New Drug Application (NDA).
Urcosimod, aimed at treating neuropathic corneal pain (NCP), a previously unaddressed condition lacking an FDA-approved treatment, illustrates a unique market opportunity. The Phase 2b clinical trial, which has commenced at Tufts Medical Center, enrolls patients specifically diagnosed with NCP, suggesting that the data generated may further validate urcosimod's efficacy and safety profile.
Investors should note that the growing trend toward single-use ampoules addresses sterility concerns that accompany the use of traditional plastic bottles in ophthalmic treatments. This innovation may enhance patient adherence and satisfaction, positioning OKYO Pharma favorably in the market for ophthalmic therapies, which is projected to expand owing to the prevalence of dry eye disease and chronic ocular pain.
Moreover, the company's prior success with urcosimod in treating dry eye disease demonstrates its capacity to deliver results, as evidenced by statistically significant endpoints. This prior validation aids in bolstering investor confidence in the drug's potential.
In summary, the promising stability data for urcosimod, combined with its innovative administration method, supports a bullish outlook for OKYO Pharma. As the company navigates through pivotal clinical trials and approaches further regulatory milestones, investors may want to closely monitor developments, as successful outcomes could substantially enhance the stock's valuation and market position.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Urcosimod in Phase 2 clinical trial for Neuropathic Corneal Pain shown to have Long-Term Stability
- Urcosimod stable in single-use ampoules for more than 2½ years
- FDA requires drug to show long-term shelf stability for approval
- Daily administration to patients via ampoules can minimize risk of contamination
LONDON and NEW YORK, March 31, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO ), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, is pleased to announce that the Company has successfully established that urcosimod (formerly known as OK-101) has been shown to be stable for over two and a half years in single-use ampoules used for administration of the drug to patients. Urcosimod is presently in a Phase 2b, randomized, placebo-controlled, double-masked, 48-patient clinical trial to treat NCP patients.
“Success for a drug in clinical development is not just about clinical data obtained from clinical trials but also requires a considerable amount of successful effort with what are called the chemistry, manufacturing and controls (CMC) part of a successful submission package to the FDA,” commented Gary S. Jacob, Ph.D., Chief Executive Officer of Okyo Pharma. "One of the major requirements for drug approval is that the drug is stable to degradation for a considerable period of time. This addresses the issue of shelf stability for a drug, and the fact that we have now established this for urcosimod is a critical positive step in meeting CMC requirements for a successful New Drug Application (NDA) with FDA.”
“Recently completed GMP stability assay testing of single-use ampoules containing urcosimod in ophthalmic solution, stored under refrigerated conditions, showed impressive stability (0.05% urcosimod – 94.8% and 0.1% urcosimod – 97.4%) after over two and a half years,” said Raj Patil, Ph.D., Chief Scientific Officer of OKYO Pharma. “We are also conducting long-term stability testing of urcosimod at room temperature, and so far, the 3-month results at room temperature are at or above 100%. It’s important to highlight that urcosimod is administered to patients as eye drops, and we have been pleased not only with the drop comfort score observed with this drug but also with the efficacy results from an earlier trial of urcosimod to treat DED. These positive results have fueled our excitement for this drug's potential to treat NCP."
Commercial marketing of ophthalmic drugs for ocular conditions which typically utilizes small plastic bottles has seen an increasing utilization of single-use ampoules by patients for ocular conditions such as DED, for ease of use, and for minimizing concerns regarding potential loss of sterility with use of plastic bottles for daily administration of drug over extended periods of weeks and months.
About the Urcosimod Phase 2b Trial in NCP Patients
The Phase 2 study is designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients. A total of 48 patients are planned to enroll for the study, with NCP disease confirmed via confocal microscopy. The trial is being conducted as a single-center trial at Tufts Medical Center and is being led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator.
About NCP
Neuropathic 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 condition.
About Urcosimod (Formerly called OK-101)
Urcosimod 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 is presently being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat 48 neuropathic corneal pain patients.
About OKYO
OKYO 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 in a Phase 2 trial.
For further information, please visit www.okyopharma.com .
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Chief Executive Officer | 917-497-7560 |
| Business Development & Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |
FAQ**
How does the successful shelf stability of urcosimod, as confirmed by OKYO Pharma Limited (OKYO), impact its potential approval and commercialization for treating neuropathic corneal pain?
Can you elaborate on the efficacy results from the earlier trial of urcosimod in treating dry eye disease, and how they might correlate with the ongoing Phase 2 trial for neuropathic corneal pain at OKYO Pharma Limited (OKYO)?
What challenges might OKYO Pharma Limited (OKYO) face in the remaining phases of clinical trials for urcosimod, considering its unique delivery method via single-use ampoules for patients?
In light of urcosimod's recent stability findings, what projections can be made about the market potential for this treatment within the multi-billion-dollar segments of neuropathic corneal pain and inflammatory dry eye disease, according to OKYO Pharma Limited (OKYO)?
**MWN-AI FAQ is based on asking OpenAI questions about OKYO Pharma Limited (NASDAQ: OKYO).
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