OKYO Pharma Announces OK-101 Officially Assigned USAN : Urcosimod
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.
OKYO Pharma (NASDAQ: OKYO) ha annunciato che il suo principale candidato farmaco OK-101 ha ricevuto ufficialmente il Nome Adottato negli Stati Uniti (USAN) 'urcosimod'. Il farmaco è attualmente in fase di sperimentazione clinica di Fase 2 per il dolore corneale neuropatico (NCP), una condizione priva di trattamenti approvati dalla FDA, e ha mostrato risultati promettenti nella Fase 2 per la malattia infiammatoria dell'occhio secco (DED).
Urcosimod è una piccola molecola coniugata a lipidi progettata per mirare ai recettori accoppiati alle proteine G oculari (GPCR), combinando proprietà anti-infiammatorie e modulanti del dolore. La sperimentazione clinica di Fase 2 per il NCP, iniziata nell'ottobre 2024, prevede di rilasciare risultati preliminari nel quarto trimestre del 2025. Il suffisso '-mod' nel nome riflette il suo ruolo come modulatore dei percorsi infiammatori e neuropatici.
OKYO Pharma (NASDAQ: OKYO) anunció que su principal candidato a fármaco OK-101 ha recibido oficialmente el Nombre Adoptado en los Estados Unidos (USAN) 'urcosimod'. El fármaco se encuentra actualmente en ensayos clínicos de Fase 2 para el dolor corneal neuropático (NCP), una condición sin tratamientos aprobados por la FDA, y ha mostrado resultados prometedores en ensayos de Fase 2 para la enfermedad inflamatoria del ojo seco (DED).
Urcosimod es una pequeña molécula conjugada a lípidos diseñada para dirigirse a los receptores acoplados a proteínas G oculares (GPCR), combinando propiedades antiinflamatorias y moduladoras del dolor. El ensayo clínico de Fase 2 para el NCP, iniciado en octubre de 2024, se espera que publique resultados preliminares en el cuarto trimestre de 2025. El sufijo '-mod' en el nombre refleja su papel como modulador de las vías inflamatorias y neuropáticas.
OKYO Pharma (NASDAQ: OKYO)는 주요 약물 후보인 OK-101이 공식적으로 미국에서 채택된 이름(USAN) '우르코시모드'로 지정되었음을 발표했습니다. 이 약물은 현재 신경병증 각막 통증(NCP)에 대한 2상 임상 시험 중이며, FDA 승인 치료제가 없는 상태에서 2상 시험에서 염증성 건조안 질환(DED)에 대한 유망한 결과를 나타냈습니다.
우르코시모드는 안구 G-단백질 결합 수용체(GPCR)를 목표로 설계된 지질 결합 소분자로, 항염증 및 통증 조절 특성을 결합하고 있습니다. 2024년 10월에 시작된 NCP에 대한 진행 중인 2상 시험은 2025년 4분기에 주요 결과를 발표할 것으로 예상됩니다. 이름의 접미사 '-mod'는 염증 및 신경병증 경로의 조절자로서의 역할을 반영합니다.
OKYO Pharma (NASDAQ: OKYO) a annoncé que son principal candidat médicament OK-101 a officiellement reçu le Nom Adopté aux États-Unis (USAN) 'urcosimod'. Le médicament est actuellement en essais cliniques de Phase 2 pour la douleur cornéenne neuropathique (NCP), une condition sans traitements approuvés par la FDA, et a montré des résultats prometteurs lors des essais de Phase 2 pour la maladie inflammatoire de l'œil sec (DED).
Urcosimod est une petite molécule conjuguée à des lipides, conçue pour cibler les récepteurs couplés aux protéines G oculaires (GPCR), combinant des propriétés anti-inflammatoires et modulatrices de la douleur. L'essai clinique de Phase 2 pour le NCP, lancé en octobre 2024, devrait publier des résultats préliminaires au quatrième trimestre 2025. Le suffixe '-mod' dans le nom reflète son rôle de modulateur des voies inflammatoires et neuropathiques.
OKYO Pharma (NASDAQ: OKYO) gab bekannt, dass sein führender Arzneimittelkandidat OK-101 offiziell den in den Vereinigten Staaten angenommenen Namen (USAN) 'urcosimod' erhalten hat. Das Medikament befindet sich derzeit in klinischen Phase-2-Studien für neuropathische Hornhautschmerzen (NCP), eine Erkrankung ohne von der FDA zugelassene Behandlungen, und hat in Phase-2-Studien für entzündliche trockene Augenkrankheit (DED) vielversprechende Ergebnisse gezeigt.
Urcosimod ist ein lipidgekoppeltes kleines Molekül, das entwickelt wurde, um gezielt Augen-G-Protein-gekoppelte Rezeptoren (GPCRs) anzusprechen, und vereint entzündungshemmende und schmerzmildernde Eigenschaften. Die laufende Phase-2-Studie für NCP, die im Oktober 2024 begonnen wurde, wird voraussichtlich im vierten Quartal 2025 erste Ergebnisse veröffentlichen. Die Endung '-mod' im Namen spiegelt seine Rolle als Modulator von entzündlichen und neuropathischen Wegen wider.
- 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
- 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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