OKYO Pharma Announces Start of Phase 2 Clinical Trial to Treat Patients with Neuropathic Corneal Pain
OKYO Pharma has initiated a Phase 2 clinical trial for OK-101 to treat Neuropathic Corneal Pain (NCP), a rare ocular condition with no FDA-approved treatments. The trial, led by Dr. Pedram Hamrah at Tufts Medical Center, will enroll 48 patients in a 12-week, double-masked, randomized, placebo-controlled study. The primary endpoint is pain relief measured by the Visual Analog Scale (VAS).
OK-101 recently showed promising results in a Phase 2 dry eye disease trial, demonstrating statistically significant improvements in symptoms like stinging/burning and ocular pain. It also reduced neuropathic corneal pain in a mouse model. OKYO Pharma is the first company to receive FDA approval for an Investigational New Drug (IND) application for NCP, which is listed as an orphan disease by the National Organization for Rare Disorders (NORD).
OKYO Pharma ha avviato un trial clinico di Fase 2 per OK-101, per trattare il Dolore Corneale Neuropatico (NCP), una rara condizione oculare senza trattamenti approvati dalla FDA. Lo studio, guidato dal Dott. Pedram Hamrah presso il Tufts Medical Center, recluterà 48 pazienti in uno studio randomizzato, controllato con placebo, in doppio cieco della durata di 12 settimane. L'obiettivo primario è il sollievo dal dolore misurato con la Scala Analogica Visiva (VAS).
OK-101 ha recentemente mostrato risultati promettenti in un trial di Fase 2 per la sindrome dell'occhio secco, dimostrando miglioramenti statisticamente significativi in sintomi come bruciore e dolore oculare. Ha anche ridotto il dolore corneale neuropatico in un modello murino. OKYO Pharma è la prima azienda a ricevere l'approvazione della FDA per una domanda di Farmaco Nuovo in Sperimentazione (IND) per il NCP, che è classificato come malattia rara dalla National Organization for Rare Disorders (NORD).
OKYO Pharma ha iniciado un ensayo clínico de Fase 2 para OK-101 para tratar el Dolor Corneal Neuropático (NCP), una rara condición ocular sin tratamientos aprobados por la FDA. El ensayo, dirigido por el Dr. Pedram Hamrah en el Tufts Medical Center, inscribirá a 48 pacientes en un estudio aleatorizado, doble ciego y controlado con placebo de 12 semanas de duración. El objetivo primario es el alivio del dolor medido por la Escala Visual Analógica (VAS).
OK-101 presentó recientemente resultados prometedores en un ensayo de Fase 2 para la enfermedad del ojo seco, demostrando mejoras estadísticamente significativas en síntomas como ardor/dolor ocular. También redujo el dolor corneal neuropático en un modelo de ratón. OKYO Pharma es la primera empresa en recibir la aprobación de la FDA para una solicitud de Medicamento Nuevo en Investigación (IND) para el NCP, que está catalogado como una enfermedad huérfana por la National Organization for Rare Disorders (NORD).
OKYO Pharma는 NCP(신경병성 각막 통증)을 치료하기 위해 OK-101에 대한 2상 임상 시험을 시작했습니다. 이 희귀 안과 질환은 FDA 승인 치료제가 없습니다. 이 임상 시험은 Tufts Medical Center의 Pedram Hamrah 박사가 주도하며, 48명의 환자를 등록하여 12주 동안 더블 맹검, 무작위, 위약 대조 방식으로 진행됩니다. 주요 목표는 시각적 아날로그 척도(VAS)를 이용한 통증 완화입니다.
OK-101은 최근 건성 안구 질환에 대한 2상 임상 시험에서 자극감/타는 느낌과 안구 통증 같은 증상에서 통계적으로 유의미한 개선을 보여주는 유망한 결과를 보였습니다. 또한 쥐 모델에서 신경병성 각막 통증을 감소시켰습니다. OKYO Pharma는 NCP에 대한 연구 신약(IND) 신청을 FDA로부터 승인 받은 최초의 회사이며, NCP는 미국 희귀질환 기구(NORD)에 의해 고아 질환으로 분류됩니다.
OKYO Pharma a lancé un essai clinique de Phase 2 pour OK-101 afin de traiter le Douleur Cornéenne Neuropathique (NCP), une condition oculaire rare sans traitements approuvés par la FDA. L'essai, dirigé par le Dr Pedram Hamrah au Tufts Medical Center, recrutera 48 patients pour une étude randomisée, en double aveugle, contrôlée par placebo sur 12 semaines. L'objectif principal est le soulagement de la douleur mesuré par l'Échelle Visuelle Analogique (VAS).
OK-101 a récemment montré des résultats prometteurs lors d'un essai de Phase 2 sur la maladie de l'œil sec, démontrant des améliorations statistiquement significatives des symptômes tels que la sensation de brulure/douleur oculaire. Il a également réduit la douleur cornéenne neuropathique dans un modèle murin. OKYO Pharma est la première entreprise à recevoir l'approbation de la FDA pour une demande de Médicament Nouveau en Recherche (IND) pour le NCP, qui est classé comme une maladie orpheline par la National Organization for Rare Disorders (NORD).
OKYO Pharma hat eine Phase-2-Studie für OK-101 zur Behandlung von neuropathischen Hornhaut-Schmerzen (NCP) gestartet, einer seltenen Augenkrankheit ohne von der FDA genehmigte Behandlungen. Die Studie, die von Dr. Pedram Hamrah am Tufts Medical Center geleitet wird, wird 48 Patienten in einer 12-wöchigen, doppelblinden, randomisierten, placebo-kontrollierten Untersuchung einschließen. Der primäre Endpunkt ist die Schmerzlinderung, gemessen mit der visuellen Analogskala (VAS).
OK-101 hat kürzlich in einer Phase-2-Studie zur Trockenaugenkrankheit vielversprechende Ergebnisse gezeigt, mit statistisch signifikanten Verbesserungen bei Symptomen wie Brennen/Stechen und Augenschmerzen. Es reduzierte auch neuropathische Hornhautschmerzen in einem Mausmodell. OKYO Pharma ist das erste Unternehmen, das von der FDA die Genehmigung für einen Antrag auf ein investigational New Drug (IND) für NCP erhalten hat, das von der National Organization for Rare Disorders (NORD) als Waisenkrankheit eingestuft wird.
- OKYO Pharma is the first company to receive FDA approval for an IND application for Neuropathic Corneal Pain
- OK-101 demonstrated statistically significant pain relief in a recently completed Phase 2 trial of dry eye disease
- OK-101 showed promising results in reducing neuropathic corneal pain in a mouse model
- The company has successfully initiated a Phase 2 clinical trial for NCP, an unmet medical need
- Neuropathic Corneal Pain currently has no FDA-approved treatments, indicating potential regulatory challenges
- The exact cause of NCP is unknown, which may complicate treatment development
Insights
The initiation of OKYO Pharma's Phase 2 clinical trial for neuropathic corneal pain (NCP) is a significant development in the ophthalmology field. NCP, recognized as an orphan disease by NORD, currently lacks FDA-approved treatments, making this study particularly noteworthy. The trial's design as a randomized, placebo-controlled, double-masked study with 48 patients adds credibility to the research methodology.
Key points to consider:
- OK-101 has shown promise in a recent Phase 2 dry eye disease trial, demonstrating statistically significant pain relief.
- The drug's potential dual efficacy in both dry eye disease and NCP could expand its market potential.
- The involvement of Dr. Pedram Hamrah, a leading expert in NCP and co-inventor of OK-101, lends scientific credibility to the study.
- If successful, this trial could position OKYO Pharma as a pioneer in NCP treatment, potentially leading to the first FDA-approved therapy for this condition.
While the results are yet to be seen, the initiation of this trial represents a positive step towards addressing an unmet medical need and could significantly impact OKYO Pharma's future prospects in the ocular therapy market.
The commencement of OKYO Pharma's Phase 2 trial for neuropathic corneal pain (NCP) represents a strategic move with potential financial implications:
- Market Opportunity: NCP, as an orphan disease without FDA-approved treatments, presents a niche market with less competition and potential for premium pricing.
- Dual-Market Strategy: OK-101's potential efficacy in both NCP and dry eye disease (a
billion-dollar market) could significantly expand OKYO's addressable market. - Risk Mitigation: The previous success of OK-101 in dry eye disease trials reduces some risk associated with this new indication.
- Intellectual Property: Dr. Hamrah's involvement as a co-inventor strengthens OKYO's IP position.
However, investors should note that with a market cap of
- Neuropathic corneal pain (NCP) is listed in the National Organization for Rare Disorders (NORD) as an orphan disease
- OKYO is the first company to have an IND application granted by the FDA for NCP
- The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients
- OK-101 demonstrated statistically significant pain relief in a recently completed Phase 2 trial of dry eye disease
LONDON and NEW YORK, Oct. 16, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a billion-dollar market, and for neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today that screening and recruitment of patients has started for a Phase 2 trial of OK-101 to treat NCP. 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 primary endpoint of this study is to measure pain relief using Visual Analog Scale (VAS) scale.
Neuropathic corneal pain (NCP) is an unmet medical need for which there are no commercially approved treatments available. 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.
OK-101 recently demonstrated favorable safety and tolerability in a Phase 2 trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and ocular pain, which are also hallmarks of NCP. OK-101 was also shown in a cutting-edge mouse model of NCP to significantly reduce neuropathic corneal pain.
The OK-101 trial is designed as a single-center trial and is being led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. An ophthalmologist and a clinician-scientist, Dr. Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is also a member of OKYO’s Scientific Advisory Board.
“I am looking forward to rigorously evaluating OK-101’s potential in treating pain symptoms in patients suffering from neuropathic corneal pain,” said Dr. Hamrah. “We have designed an effective protocol to test our hypothesis in this patient population after productive FDA interactions and we will be closely overseeing the conduct of this trial at Tufts Medical Center.”
“The initiation of this trial of topically applied OK-101 to treat NCP marks a significant step forward for the company as we have been laser focused on moving this drug candidate into a clinical trial to treat NCP over the last 12 months,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “Importantly, this clinical study is a follow-on to the completion of a 240-patient trial of OK-101 in dry eye disease patients, and the results from that trial showed statistical significance in reducing ocular pain. The drug has also been shown in pre-clinical studies to have potent anti-inflammatory and neuropathic corneal pain reducing activities in animal models, and we are eager to evaluate its potential benefits in patients with NCP.”
About OK-101
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. OK-101 was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. OK-101 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 enhance the residence time of OK-101 within the ocular environment. OK-101 showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial of OK-101 to treat DED.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of DED and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat inflammatory DED and ocular pain. In addition to the recently completed Phase 2 trial of OK-101 to treat DED patients, OKYO is also evaluating OK-101 to treat NCP patients with the just announced opening of a Phase 2 trial to treat the debilitating conditions of NCP. For further information, please visit www.okyopharma.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2024. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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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