Full Press Release Details
Pharma Announces OK-101 Officially Assigned USAN : Urcosimod
and New York, NY, February 12, 2025. 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".
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).
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.
S. Jacob, Ph.D., Chief Executive Officer of Okyo Pharma, commented:
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."
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
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.
ongoing Phase 2 trial for neuropathic corneal pain was initiated in October 2024. The company is planning to release top-line results
Pharma remains committed to addressing the unmet needs of patients with sight-threatening and quality-of-life-impacting conditions.
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.
Urcosimod (Formerly called OK-101)
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.
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.
further information, please visit www.okyopharma.com.
| OKYO Pharma Limited | Gary S. Jacob, Chief Executive Officer | 917-497-7560 | ||
| Business Development & Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |