OKYO Pharma Announces First Patient Dosed in the First Clinical Trial to Treat Neuropathic Corneal Pain
OKYO Pharma (NASDAQ: OKYO) has initiated its Phase 2 clinical trial for OK-101, announcing the first patient dosing in a study targeting Neuropathic Corneal Pain (NCP). The trial is designed as a double-masked, randomized, 12-week placebo-controlled study involving 48 patients with NCP confirmed via confocal microscopy. OK-101 is a novel, non-opioid therapeutic candidate and the first drug to receive FDA IND approval specifically for NCP treatment. The study is being conducted at a single center under the leadership of Dr. Pedram Hamrah at Tufts Medical Center, a leading expert in NCP treatment and research.
OKYO Pharma (NASDAQ: OKYO) ha avviato il suo trial clinico di Fase 2 per OK-101, annunciando la somministrazione al primo paziente in uno studio mirato al Dolore Corneale Neuropatico (NCP). Lo studio è progettato come un trial controllato con placebo, randomizzato e in doppio cieco della durata di 12 settimane, coinvolgendo 48 pazienti con NCP confermato tramite microscopia confocale. OK-101 è un candidato terapeutico innovativo, non oppioide, ed è il primo farmaco ad aver ricevuto l'approvazione FDA IND specificatamente per il trattamento del NCP. Lo studio è condotto in un singolo centro sotto la guida del Dr. Pedram Hamrah presso il Tufts Medical Center, un esperto riconosciuto nel trattamento e nella ricerca sul NCP.
OKYO Pharma (NASDAQ: OKYO) ha iniciado su ensayo clínico de Fase 2 para OK-101, anunciando la dosificación del primer paciente en un estudio dirigido al Dolor Corneal Neuropático (NCP). El ensayo está diseñado como un estudio controlado con placebo, aleatorizado y doble ciego de 12 semanas que involucra a 48 pacientes con NCP confirmado mediante microscopia confocal. OK-101 es un candidato terapéutico novedoso, no opioide, y es el primer medicamento en recibir la aprobación IND de la FDA específicamente para el tratamiento del NCP. El estudio se realiza en un solo centro bajo la dirección del Dr. Pedram Hamrah en el Tufts Medical Center, un reconocido experto en el tratamiento y la investigación del NCP.
OKYO 제약 (NASDAQ: OKYO)는 OK-101의 2상 임상 시험을 시작했으며, 신경병증 각막 통증(NCP)을 목표로 하는 연구에서 첫 번째 환자에게 약물 투여를 발표했습니다. 이 시험은 48명의 NCP 환자를 대상으로 한 12주간의 이중 맹검, 무작위, 위약 대조 연구로 설계되었습니다. OK-101은 혁신적인 비-opioid 치료 후보로, NCP 치료를 위해 FDA IND 승인을 받은 첫 번째 약물입니다. 이 연구는 Tufts Medical Center에서 NCP 치료 및 연구에서 저명한 전문가인 Dr. Pedram Hamrah의 지휘하에 단일 센터에서 수행되고 있습니다.
OKYO Pharma (NASDAQ: OKYO) a lancé son essai clinique de Phase 2 pour OK-101, annonçant la première dose administrée à un patient dans une étude visant à traiter la Douleur Cornéenne Neuropathique (NCP). L'essai est conçu comme une étude contrôlée par placebo, randomisée et en double aveugle de 12 semaines impliquant 48 patients dont le NCP a été confirmé par microscopie confocale. OK-101 est un candidat thérapeutique novateur, non opioïde, et c'est le premier médicament à avoir reçu l'approbation IND de la FDA spécifiquement pour le traitement de la NCP. L'étude est menée dans un seul centre sous la direction du Dr Pedram Hamrah au Tufts Medical Center, un expert de renom dans le traitement et la recherche sur la NCP.
OKYO Pharma (NASDAQ: OKYO) hat seine Phase-2-Studie für OK-101 gestartet und die erste Dosierung bei einem Patienten in einer Untersuchung bekannt gegeben, die sich auf neuropathischen Hornhaut-Schmerz (NCP) konzentriert. Die Studie ist als doppelblinder, randomisierter, 12-wöchiger Placebo-kontrollierter Versuch angelegt und umfasst 48 Patienten mit über NCP bestätigtem Befund durch konfokale Mikroskopie. OK-101 ist ein neuartiger, nicht-opioider Therapeutik-Kandidat und das erste Medikament, das von der FDA für NCP-Behandlungen eine IND-Zulassung erhielt. Die Studie wird in einem einzigen Zentrum unter der Leitung von Dr. Pedram Hamrah am Tufts Medical Center durchgeführt, einem anerkannten Experten für NCP-Behandlung und -Forschung.
- First FDA IND approval granted specifically for NCP treatment
- Phase 2 trial successfully initiated with first patient dosed
- Novel non-opioid therapeutic targeting an unmet medical need
- Trial led by world-renowned NCP expert Dr. Pedram Hamrah
- Small trial size of only 48 patients
- Single-center study design may limit result interpretation
- No FDA-approved treatments exist, indicating potential regulatory challenges
Insights
The initiation of the first Phase 2 trial specifically targeting Neuropathic Corneal Pain (NCP) represents a significant milestone in ophthalmology. The study's design with 48 patients in a double-masked, randomized, placebo-controlled format demonstrates robust clinical methodology. The trial's leadership by Dr. Hamrah, a recognized authority in NCP, adds credibility to the research.
Three key aspects make this development particularly noteworthy: 1) It's the first FDA-approved IND specifically for NCP treatment, 2) The use of confocal microscopy for disease confirmation provides objective diagnostic criteria and 3) The non-opioid approach addresses both efficacy and safety concerns in pain management. The 12-week duration should provide sufficient data to evaluate both safety and initial efficacy signals.
This development positions OKYO Pharma advantageously in an untapped market segment. With no FDA-approved treatments for NCP, OK-101 could potentially secure first-mover advantage in this specialized ophthalmology niche. The global implications are significant given that NCP affects patients worldwide and current treatment options are
The partnership with Tufts Medical Center and the planned center of excellence for ocular pain suggests a long-term strategic approach to market development. Success in this trial could establish OKYO as a pioneer in ocular pain management, potentially leading to broader applications in related conditions. The unmet medical need and lack of competition in this space could translate to substantial market opportunity if the trial yields positive results.
- OK-101 is the first drug candidate to enroll patients specifically diagnosed with Neuropathic Corneal Pain (NCP) in a clinical trial
- The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients
- OK-101 is the first IND granted by FDA to treat patients with NCP
LONDON and NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat corneal neuropathic pain (NCP), an ocular condition associated with pain but without an FDA-approved therapy, is pleased to announce that the first patient has been dosed in the Phase 2 trial of topical ocular 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.
OK-101, a novel, non-opioid therapeutic candidate, is designed to target and alleviate the debilitating pain associated with corneal nerve damage, a condition for which there are currently no FDA approved treatments. Neuropathic corneal pain, often resulting from conditions like dry eye disease, surgery, or infections, can severely impact a patient's quality of life, with current management options limited to pain relief strategies that offer only partial or temporary respite.
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. He is one of the world’s foremost experts on NCP and treats patients with ocular pain from across the United States and worldwide. His previous research has demonstrated safety and efficacy of various topical and systemic treatments for ocular pain and has led to the development of new diagnostic markers for ocular pain by in vivo confocal microscopy. In addition to his work on OK-101, of which he is a co-inventor and member of OKYO’s Scientific Advisory Board, Dr. Hamrah is conducting studies on developing new corneal nerve function tests and plans to launch a new center of excellence for ocular pain and ocular surface disease at Tufts Medical Center.
“Enrolling the first patient in this clinical trial is an important first step towards our goal of determining the safety and efficacy of OK-101 for the treatment of NCP,” said Dr. Hamrah. “There is a significant, unmet need for an approved therapy to help mitigate eye pain in patients with NCP around the world. We look forward to continuing to advance recruitment in the coming weeks and months, and to rigorously evaluate this experimental therapy in this patient population.”
“We are excited to announce the enrollment of the first patient in our Phase 2 clinical trial of OK-101,” said Dr. Gary S. Jacob, CEO of OKYO Pharma. “This is a key step forward in our mission to provide relief for patients suffering from neuropathic corneal pain, a chronic condition for which no FDA-approved treatments exist today. OK-101 represents a potential breakthrough in the treatment of this condition, and we remain committed to advancing its development with the goal of delivering a novel therapeutic option to patients in need.”
For further information on the trial or to inquire about participation, please visit https://clinicaltrials.gov/study/NCT06637527?intr=OK-101&rank=2
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. There are no approved commercial treatments currently available for this condition.
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
What is the current status of OKYO's Phase 2 trial for OK-101?
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What makes OKYO's OK-101 treatment unique for NCP?
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