OKYO Pharma Announces Positive Data in Long-Term Stability of Urcosimod
OKYO Pharma (NASDAQ: OKYO) has announced significant stability data for its drug candidate urcosimod, currently in Phase 2b clinical trials for Neuropathic Corneal Pain (NCP). The drug has demonstrated remarkable stability in single-use ampoules over a 2½-year period under refrigerated conditions, with stability rates of 94.8% for 0.05% concentration and 97.4% for 0.1% concentration.
The stability testing is a important requirement for FDA approval, addressing shelf-life concerns for the drug. Additionally, room temperature stability testing has shown promising early results, with 3-month stability rates at or above 100%. The company notes that single-use ampoules are increasingly preferred for ophthalmic drugs over plastic bottles, offering better sterility control for long-term daily administration.
Urcosimod is being evaluated in a randomized, placebo-controlled, double-masked trial involving 48 patients for NCP, a severe ocular condition currently lacking FDA-approved treatments. The drug has also shown potential in treating inflammatory dry eye disease (DED), a multi-billion-dollar market opportunity.
OKYO Pharma (NASDAQ: OKYO) ha annunciato dati di stabilità significativi per il suo candidato farmaco urcosimod, attualmente in fase di sperimentazione clinica di fase 2b per il dolore corneale neuropatico (NCP). Il farmaco ha dimostrato una stabilità notevole in fiale monouso per un periodo di 2½ anni in condizioni refrigerate, con tassi di stabilità del 94,8% per la concentrazione dello 0,05% e del 97,4% per la concentrazione dello 0,1%.
Il test di stabilità è un requisito importante per l'approvazione della FDA, affrontando le preoccupazioni relative alla durata di conservazione del farmaco. Inoltre, i test di stabilità a temperatura ambiente hanno mostrato risultati promettenti, con tassi di stabilità a 3 mesi pari o superiori al 100%. L'azienda osserva che le fiale monouso sono sempre più preferite per i farmaci oftalmici rispetto alle bottiglie di plastica, offrendo un migliore controllo della sterilità per l'amministrazione quotidiana a lungo termine.
Urcosimod è attualmente valutato in uno studio randomizzato, controllato con placebo e in doppio cieco che coinvolge 48 pazienti per NCP, una grave condizione oculare attualmente priva di trattamenti approvati dalla FDA. Il farmaco ha anche mostrato potenziale nel trattamento della malattia infiammatoria dell'occhio secco (DED), un'opportunità di mercato da miliardi di dollari.
OKYO Pharma (NASDAQ: OKYO) ha anunciado datos de estabilidad significativos para su candidato a fármaco urcosimod, actualmente en ensayos clínicos de fase 2b para el dolor corneal neuropático (NCP). El fármaco ha demostrado una estabilidad notable en ampollas de un solo uso durante un período de 2½ años en condiciones refrigeradas, con tasas de estabilidad del 94,8% para la concentración del 0,05% y del 97,4% para la concentración del 0,1%.
La prueba de estabilidad es un requisito importante para la aprobación de la FDA, abordando las preocupaciones sobre la vida útil del fármaco. Además, las pruebas de estabilidad a temperatura ambiente han mostrado resultados preliminares prometedores, con tasas de estabilidad a 3 meses en o por encima del 100%. La empresa señala que las ampollas de un solo uso son cada vez más preferidas para los fármacos oftálmicos en lugar de botellas de plástico, ofreciendo un mejor control de esterilidad para la administración diaria a largo plazo.
Urcosimod se está evaluando en un ensayo aleatorizado, controlado con placebo y doble ciego que involucra a 48 pacientes para NCP, una grave condición ocular que actualmente carece de tratamientos aprobados por la FDA. El fármaco también ha mostrado potencial en el tratamiento de la enfermedad inflamatoria del ojo seco (DED), una oportunidad de mercado multimillonaria.
OKYO Pharma (NASDAQ: OKYO)는 현재 신경병성 각막 통증(NCP)에 대한 2b상 임상 시험 중인 약물 후보인 우르코시모드의 중요한 안정성 데이터를 발표했습니다. 이 약물은 냉장 조건에서 2½년 동안 단일 사용 앰플에서 놀라운 안정성을 보여주었으며, 0.05% 농도에서 94.8%, 0.1% 농도에서 97.4%의 안정성 비율을 기록했습니다.
안정성 테스트는 FDA 승인을 위한 중요한 요구 사항으로, 약물의 유통 기한에 대한 우려를 해결합니다. 또한 실온 안정성 테스트는 3개월 안정성 비율이 100% 이상인 유망한 초기 결과를 보여주었습니다. 회사는 단일 사용 앰플이 플라스틱 병보다 안과 약물에 대해 점점 더 선호되고 있으며, 장기적인 일일 투여를 위한 더 나은 멸균 관리를 제공한다고 언급했습니다.
우르코시모드는 NCP를 위한 48명의 환자가 참여하는 무작위, 위약 대조, 이중 맹검 시험에서 평가되고 있으며, 현재 FDA 승인이 없는 심각한 안과 질환입니다. 이 약물은 또한 수십억 달러 규모의 시장 기회인 염증성 건성 안구 질환(DED) 치료에서도 잠재력을 보여주었습니다.
OKYO Pharma (NASDAQ: OKYO) a annoncé des données de stabilité significatives pour son candidat médicament urcosimod, actuellement en essais cliniques de phase 2b pour la douleur cornéenne neuropathique (NCP). Le médicament a démontré une stabilité remarquable dans des ampoules à usage unique pendant une période de 2½ ans dans des conditions réfrigérées, avec des taux de stabilité de 94,8 % pour la concentration de 0,05 % et de 97,4 % pour la concentration de 0,1 %.
Les tests de stabilité sont une exigence importante pour l'approbation de la FDA, répondant aux préoccupations concernant la durée de conservation du médicament. De plus, les tests de stabilité à température ambiante ont montré des résultats préliminaires prometteurs, avec des taux de stabilité à 3 mois égaux ou supérieurs à 100 %. L'entreprise note que les ampoules à usage unique sont de plus en plus préférées pour les médicaments ophtalmiques par rapport aux bouteilles en plastique, offrant un meilleur contrôle de la stérilité pour une administration quotidienne à long terme.
Urcosimod est évalué dans un essai randomisé, contrôlé par placebo et en double aveugle impliquant 48 patients pour NCP, une affection oculaire grave actuellement dépourvue de traitements approuvés par la FDA. Le médicament a également montré un potentiel dans le traitement de la maladie inflammatoire de l'œil sec (DED), une opportunité de marché de plusieurs milliards de dollars.
OKYO Pharma (NASDAQ: OKYO) hat bedeutende Stabilitätsdaten für seinen Arzneimittelkandidaten Urcosimod bekannt gegeben, der sich derzeit in klinischen Phase-2b-Studien zur neuropathischen Hornhautentzündung (NCP) befindet. Das Medikament hat über einen Zeitraum von 2½ Jahren unter Kühlschrankbedingungen in Einmal-Ampullen bemerkenswerte Stabilität gezeigt, mit Stabilitätsraten von 94,8% für die 0,05%-Konzentration und 97,4% für die 0,1%-Konzentration.
Die Stabilitätstests sind eine wichtige Voraussetzung für die FDA-Zulassung und behandeln die Bedenken hinsichtlich der Haltbarkeit des Medikaments. Darüber hinaus haben Stabilitätstests bei Raumtemperatur vielversprechende frühe Ergebnisse gezeigt, mit Stabilitätsraten von 3 Monaten, die bei oder über 100% liegen. Das Unternehmen weist darauf hin, dass Einmal-Ampullen immer häufiger für ophthalmologische Arzneimittel bevorzugt werden, da sie eine bessere Sterilitätskontrolle für die langfristige tägliche Anwendung bieten.
Urcosimod wird in einer randomisierten, placebo-kontrollierten, doppelblinden Studie mit 48 Patienten für NCP evaluiert, einer schweren Augenkrankheit, die derzeit keine von der FDA zugelassenen Behandlungen hat. Das Medikament hat auch Potenzial bei der Behandlung der entzündlichen Erkrankung des trockenen Auges (DED) gezeigt, einem Markt mit Milliardenmöglichkeiten.
- Strong long-term stability data showing 94.8-97.4% after 2.5 years
- Promising room temperature stability results at 3 months
- Targeting two markets: NCP (unmet medical need) and DED (multi-billion dollar market)
- Single-use ampoule format provides competitive advantage in sterility control
- Still in Phase 2b trials - several steps away from potential commercialization
- Requires refrigerated storage conditions for optimal stability
Insights
OKYO Pharma's stability data for urcosimod represents a significant milestone in their regulatory pathway. The demonstrated 2.5-year stability in single-use ampoules addresses a critical FDA requirement for drug approval, substantially reducing CMC-related regulatory risks. For context, many promising drug candidates fail during development not due to efficacy issues but because of formulation stability challenges.
The specific stability percentages (94.8% for 0.05% concentration and 97.4% for 0.1% concentration) are particularly impressive for an ophthalmic preparation. The preliminary room temperature stability data showing 100% stability at 3 months further strengthens the commercial viability of urcosimod.
This development is especially noteworthy considering urcosimod targets neuropathic corneal pain - a condition with no FDA-approved treatments. The single-use ampoule delivery system provides additional advantages by reducing contamination risks compared to multi-dose bottles, which is particularly important for chronic ophthalmic conditions requiring long-term treatment.
While efficacy in the ongoing Phase 2b trial remains the primary value driver, successful CMC development significantly enhances the probability of eventual regulatory success and streamlines the path to commercialization in the potentially lucrative inflammatory dry eye disease market, which the company notes is valued in the billions.
- 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 (
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 |
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