OKYO Pharma Announces OK-101 Officially Assigned USAN : Urcosimod
Rhea-AI Summary
OKYO Pharma (NASDAQ: OKYO) announced that its lead drug candidate OK-101 has been officially assigned the United States Adopted Name (USAN) 'urcosimod'. The drug is currently in Phase 2 clinical trials for neuropathic corneal pain (NCP), a condition without FDA-approved treatments, and has shown promising results in Phase 2 trials for inflammatory dry eye disease (DED).
Urcosimod is a lipid-conjugated small molecule designed to target ocular G-protein coupled receptors (GPCRs), combining anti-inflammatory and pain-modulating properties. The ongoing Phase 2 trial for NCP, initiated in October 2024, is expected to release top-line results in Q4 2025. The suffix '-mod' in the name reflects its role as a modulator of inflammatory and neuropathic pathways.
Positive
- Previous Phase 2 trial for dry eye disease showed strong pain-reducing effects and favorable safety profile
- Drug addresses both inflammatory dry eye disease (multi-billion-dollar market) and neuropathic corneal pain (unmet medical need)
- Dual mechanism targeting both inflammation and pain through GPCR modulation
Negative
- Phase 2 trial results for NCP not expected until Q4 2025
- No FDA approval yet for either indication
Insights
The USAN designation of 'urcosimod' for OK-101 represents more than just a naming milestone - it's a important step in OKYO Pharma's commercialization strategy. This designation typically signals advancement in the drug development process and often precedes important regulatory submissions. The timing is particularly strategic as it coincides with the company's ongoing Phase 2 trial in neuropathic corneal pain.
The drug's dual-market strategy targeting both NCP and DED is particularly noteworthy. While DED represents a multi-billion dollar market with established players, the NCP opportunity is potentially more valuable from a competitive standpoint, as there are currently no FDA-approved treatments. This first-mover advantage in NCP could provide significant pricing power and market exclusivity benefits.
Urcosimod's lipid-conjugated small molecule platform technology, which enables targeted modulation of ocular G-protein coupled receptors, represents a significant technological advancement. The ability to combine both anti-inflammatory and analgesic properties in a single molecule could provide superior efficacy compared to traditional monotherapy approaches, potentially leading to better patient outcomes and stronger market positioning.
The upcoming Q4 2025 data readout from the NCP Phase 2 trial will be a critical catalyst. Previous positive results in DED trials, particularly the strong pain-reducing effects, suggest potential efficacy in NCP as well, given the mechanistic overlap in pain modulation pathways. This could de-risk the current clinical program to some extent, though investors should note that success in one indication doesn't guarantee success in another.
LONDON and NEW YORK, Feb. 12, 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 its lead asset, OK-101, has been officially assigned the United States Adopted Name (USAN) "urcosimod".
The USAN designation reflects Okyo Pharma’s commitment to developing new therapies for unmet medical needs in ophthalmology. The suffix “-mod” in urcosimod denotes its classification as a modulator of key inflammatory and neuropathic pathways, critical to addressing ocular conditions such as neuropathic corneal pain (NCP) and dry eye disease (DED).
The USAN program, jointly managed by the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA), assigns unique nonproprietary names to pharmaceutical substances to ensure clarity in medical communication. This naming milestone underscores the progress of urcosimod (OK-101) in its clinical development program.
Gary S. Jacob, Ph.D., Chief Executive Officer of Okyo Pharma, commented:
“We are thrilled to announce that OK-101 has been granted the name urcosimod, marking an important step in its development as a therapeutic option for patients suffering from serious ocular conditions. Urcosimod is currently in a Phase 2 clinical trial for neuropathic corneal pain, an area of significant unmet medical need. This follows the encouraging results observed in our prior Phase 2 trial of urcosimod for dry eye disease, where the drug demonstrated strong pain reducing effects and a favorable safety profile.”
Dr. Jacob continued: “Neuropathic corneal pain is a debilitating condition for which there are currently no FDA-approved treatments. We believe urcosimod’s dual anti-inflammatory and analgesic properties uniquely position it to address both the symptoms and the underlying causes of this condition. With the USAN name granted, we are further cementing the path forward for this promising therapeutic candidate.”
Okyo Pharma’s innovative lipid-conjugated small molecule platform enables urcosimod to target and modulate ocular G-protein coupled receptors (GPCRs), reducing inflammation and pain at the source. The drug’s design, combining anti-inflammatory and pain-modulating properties, sets it apart from traditional approaches in ocular disease treatment.
The ongoing Phase 2 trial for neuropathic corneal pain was initiated in October 2024. The company is planning to release top-line results in Q4 2025.
Okyo Pharma remains committed to addressing the unmet needs of patients with sight-threatening and quality-of-life-impacting conditions.
About NCP
Neuropathic corneal pain (NCP) is a condition that causes pain and sensitivity of the eyes, face, or head. The exact cause of NCP is unknown but thought to result from nerve damage to the cornea combined with inflammation. NCP, which can exhibit as a severe, chronic, or 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 (NCP), 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 DED, and is presently being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat 48 NCP patients.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of NCP and DED, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat NCP and inflammatory DED. In addition to the completed Phase 2 trial of urcosimod to treat DED patients, OKYO is also currently evaluating urcosimod to treat NCP 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
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