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OKYO Pharma宣布提交OK-101治疗神经性角膜疼痛(“NCP”)的研究性新药(IND)申请

OKYO Pharma Announces Filing of an Investigational New Drug (IND) Application for OK-101 to Treat Neuropathic Corneal Pain (“NCP”)

GlobeNewswire 等信源发布 2023-10-09 19:00

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OKYO plans to initiate a 40-patient OK-101 open-label clinical trial in Q1 2024 with Dr Pedram Hamrah, Tufts Medical Center, as Principal Investigator, a leading expert in treating patients with NCP.Second clinical indication for OK-101 which is currently in 240-patient Phase 2 clinical trial to treat dry eye disease, with top-line data anticipated in December 2023.

OKYO计划在2024年第一季度与塔夫茨医疗中心的Pedram Hamrah博士作为主要研究者,治疗NCP患者的主要专家,开展40名患者的OK-101开放标签临床试验。目前OK-101的第二临床适应症在240名患者的2期临床试验中,用于治疗干眼症,预计2023年12月将获得一线数据。

LONDON and NEW YORK, Oct. 09, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (“DED”), a multi-billion-dollar market, and for neuropathic corneal pain, a severe ocular condition with no FDA approved therapy, today announced that it filed an Investigational New Drug (IND) application with the U.S.

伦敦和纽约,2023年10月9日(GLOBE NEWSWIRE)-OKYO Pharma Limited(纳斯达克股票代码:OKYO),一家临床阶段生物制药公司,开发用于治疗炎症性干眼病(“DED”)的创新疗法,数十亿美元的市场,以及神经性角膜疼痛,这是一种没有FDA批准治疗的严重眼病,今天宣布它向美国提交了研究性新药(IND)申请。

Food and Drug Administration (FDA) for the development of OK-101 to treat Neuropathic Corneal Pain (NCP). Study enrollment is planned to commence during Q1 2024 following IND allowance by the FDA. NCP remains a major unmet medical need for the ocular community, as there is no FDA-approved drug to treat NCP and this trial provides the opportunity to establish OK-101’s potential to treat this condition.

食品和药物管理局(FDA)开发OK-101治疗神经性角膜疼痛(NCP)。根据FDA的IND补贴,研究报名计划于2024年第一季度开始。NCP仍然是眼科社区尚未满足的主要医疗需求,因为没有FDA批准的用于治疗NCP的药物,并且该试验提供了建立OK-101治疗这种病症的潜力的机会。

The open-label trial will provide an opportunity to evaluate the safety and efficacy of OK-101 for NCP in a real-world clinical setting, fostering a better understanding of its potential benefits for patients. The NCP trial will be led by Pedram Hamrah, MD, Professor and Vice Chair of Research and Academic Programs, Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at Tufts Medical Center.

开放标签试验将提供一个机会来评估OK-101在NCP实际临床环境中的安全性和有效性,从而更好地了解其对患者的潜在益处。NCP试验将由Pedram Hamrah医学博士,研究和学术项目教授兼副主席,角膜服务联合主任和塔夫茨医学中心转化眼免疫学中心主任领导。

An ophthalmologist and a clinician-scientist, Dr. Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is a member of OKYO’s S.

Hamrah博士是眼科医生和临床科学家,是NCP的领先专家,也是OK-101专利的共同发明人。他是OKYO's的成员。