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OKYO Pharma to Host Key Opinion Leader Event to Discuss New and Comprehensive Data From Phase 2 Dry Eye Disease Trial

OKYO Pharma to Host Key Opinion Leader Event to Discuss New and Comprehensive Data From Phase 2 Dry Eye Disease Trial

OKYO Pharma将举办关键意见领袖活动,讨论2期干眼病试验的新综合数据
OKYO Pharma ·  03/21 00:00

Phase 2 OK-101 efficacy data to be released March 22nd, 2024-

第二阶段 OK-101 疗效数据将于 2024 年 3 月 22 日公布-

-KOL Event to be held on April 9th, 2024 at 12 PM ET-

-KOL 活动将于美国东部时间 2024 年 4 月 9 日中午 12 点举行-

London and New York, NY, March 21, 2024 – OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announces that it will be hosting a Key Opinion Leader (KOL) event on April 9th, 2024 at 12:00 PM ET to discuss in depth the findings of the new and comprehensive efficacy data readout from the Phase 2 trial of OK-101 in dry eye disease, which will be announced on March 22nd, 2024.

伦敦和纽约州纽约,2024年3月21日——OKYO Pharma Limited(纳斯达克股票代码:OKYO)是一家临床阶段的生物制药公司,开发创新眼部疗法,用于治疗价值数十亿美元的市场炎症性干眼病(DED)和前眼节疾病,包括神经病理性角膜疼痛(NCP),一种与疼痛有关但未获美国食品药品管理局批准的疗法的眼部疾病。它将在美国东部时间2024年4月9日中午12点举办关键意见领袖(KOL)活动,深入讨论新的全面调查结果OK-101 干眼病二期试验的疗效数据读出,该试验将于 2024 年 3 月 22 日公布。

The event will feature Jay Pepose, MD, PhD, who will review details from the company's Phase 2 trial evaluating OK-101 in Dry Eye Disease, and Anat Galor, MD, MSPH who will discuss the unmet need for a topical treatment that improves ocular pain and differentiating features of OK-101. OKYO Pharma's management team will also be in attendance to present an overview of OK-101's mechanism of action.

本次活动将邀请医学博士、医学博士杰伊·皮波斯(Jay Pepose),他将回顾该公司评估 OK-101 治疗干眼病的二期试验的细节,以及医学博士、MSPH Anat Galor,他将讨论改善眼痛和区分 OK-101 特征的局部治疗的未得到满足的需求。OKYO Pharma 的管理团队也将出席,概述 OK-101 的行动机制。

Event details:

活动详情:

Date: Tuesday, April 9th, 2024

日期:2024 年 4 月 9 日星期二

Time: 12:00 PM ET

时间:美国东部时间下午 12:00

Jay Pepose, MD, PhD, Founder and Medical Director of the Pepose Vision Institute and Professor of Clinical Ophthalmology at Washington University School of Medicine, has nearly 40 years of experience as both a treating physician and a widely published researcher. He is the founder and Medical Director of the Pepose Vision Institute and a professor of Clinical Ophthalmology & Visual Sciences at Washington University School of Medicine in St. Louis. Dr. Pepose is actively involved in clinical trials and has served as an investigator on over 30 studies evaluating new therapeutics and technology in a broad range of ophthalmic indications, including dry eye. He has published over 200 peer-reviewed articles and has served on the editorial boards of several prestigious ophthalmology journals. Dr. Pepose received an A.B. and M.A. in neurophysiology from Brandeis University and completed the M.D. Ph.D. program at the UCLA School of Medicine. Dr. Pepose completed his ophthalmology residency at the Wilmer Institute at the Johns Hopkins Medical Center and his fellowship training at Georgetown University Medical Center.

Jay Pepose,医学博士,Pepose Vision Institute创始人兼医学总监,华盛顿大学医学院临床眼科教授,拥有近40年的治疗医生和广泛发表的研究人员的经验。他是Pepose Vision Institute的创始人兼医学总监,也是圣路易斯华盛顿大学医学院临床眼科和视觉科学教授。Pepose博士积极参与临床试验,曾担任30多项研究的研究员,这些研究评估了包括干眼在内的各种眼科适应症中的新疗法和技术。他发表了 200 多篇经过同行评审的文章,并曾在多家著名眼科期刊的编辑委员会任职。Pepose 博士拥有布兰迪斯大学神经生理学学士学位和硕士学位,并在加州大学洛杉矶分校医学院完成了医学博士学位课程。Pepose博士在约翰·霍普金斯大学医学中心威尔默研究所完成了眼科住院医师实习,并在乔治敦大学医学中心完成了奖学金培训。

Anat Galor, MD, MSPH, Professor of Ophthalmology, University of Miami Miller School of Medicine, is a cornea and uveitis trained specialist with dual appointments at the Bascom Palmer Eye Institute and the Miami VA medical center. Dr. Galor completed an ophthalmology residency at the Cole Eye Cleveland Clinic, a uveitis fellowship at the Wilmer Eye Institute, and a cornea and external diseases fellowship at Bascom Palmer Eye Institute. Dr. Galor currently runs the ocular surface pain program at the Bascom Palmer Eye Institute and the Miami VA and has focused her research on understanding mechanisms of pain in dry eye, with an emphasis on studying new diagnostic and treatment modalities.

Anat Galor,医学博士、MSPH,迈阿密大学米勒医学院眼科教授,是一名受过角膜和葡萄膜炎培训的专家,曾在巴斯科姆·帕尔默眼科研究所和弗吉尼亚州迈阿密医疗中心两次任职。Galor博士在Cole Eye Cleveland诊所完成了眼科住院医师实习,在威尔默眼科研究所完成了葡萄膜炎研究金,并在Bascom Palmer眼科研究所完成了角膜和外部疾病研究金。Galor博士目前在巴斯科姆·帕尔默眼科研究所和弗吉尼亚州迈阿密负责眼表疼痛项目,她的研究重点是了解干眼症的疼痛机制,重点是研究新的诊断和治疗方式。

In a previous preliminary data readout, OK-101 showed statistically significant drug effects in FDA-recognized efficacy endpoints as early as the 15-day first visit after dosing. Additionally, statistically significant improvements were observed in both a "sign" (total conjunctival staining) and two "symptoms" (burning/stinging and blurred vision), which are FDA-recognized endpoints of dry eye disease.

在先前的初步数据读取中,OK-101 早在给药后的 15 天首次就诊时,在 FDA 认可的疗效终点中就显示出具有统计学意义的药物作用。此外,在 “体征”(全结膜染色)和两个 “症状”(烧灼/刺痛和视力模糊)中均观察到统计学上的显著改善,这两个 “症状” 是美国食品药品管理局认可的干眼病终点。

OK-101 Phase 2 Trial in DED Patients

OK-101 针对 DED 患者的二期试验

The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID). Patients were randomly divided into 3 cohorts, with one of the cohorts dosed with 0.05% OK-101 (n=81), a second with 0.1% OK-101 (n=80), and the third cohort with vehicle (n=79). The duration of a patient's treatment was 14 weeks, including a 2-week run-in period on placebo, to exclude placebo responders from the study, followed by 12 weeks in the randomized portion of the study.

这项双面罩、随机、安慰剂对照的2期试验在美国的六个地点进行,招收了240名受试者,每天服用两次DED(BID)。患者被随机分为 3 个队列,其中一个队列的剂量为 0.05% 的 OK-101(n=81),第二个队列的剂量为 0.1% 的 OK-101(n=80),第三组使用载体(n=79)。患者的治疗持续时间为14周,包括2周的安慰剂试用期,将安慰剂反应者排除在研究之外,随后在研究的随机部分中为12周。

About OK-101

关于 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 efficacy signals 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 recently showed statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial of OK-101 to treat DED.

OK-101 是 ChemR23 G 蛋白偶联受体的脂质偶联的 chemerin 肽激动剂,该受体通常存在于负责炎症反应的眼睛免疫细胞中。OK-101 使用膜锚肽技术开发,用于生产治疗干眼病的新型长效候选药物。在干眼病和角膜神经性疼痛 (NCP) 的小鼠模型中,OK-101 已被证明可分别产生抗炎和减痛的功效信号,旨在通过在药物分子中加入脂质锚来延长 OK-101 在眼部环境中的停留时间来对抗冲洗。在最近完成的 OK-101 治疗 DED 的 2 期、多中心、双盲、安慰剂对照试验中,OK-101 在多个终点显示出统计学意义。

About OKYO

关于 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 DED trial, OKYO also has plans underway for the opening of a Phase 2 trial for OK-101 to treat NCP in patients with this debilitating condition. For further information, please visit www.okyopharma.com.

东洋制药有限公司(纳斯达克股票代码:OKYO)是一家临床阶段的生物制药公司,开发治疗DED和NCP的创新疗法,普通股在纳斯达克资本市场上市交易。OKYO 专注于发现和开发用于治疗炎症 DED 和眼痛的新分子。除了最近完成的二期 DED 试验外,OKYO 还计划启动 OK-101 的 2 期试验,以治疗患有这种虚弱性疾病的患者的 NCP。欲了解更多信息,请访问 www.okyopharma.com

Forward-Looking Statements

前瞻性陈述

Certain statements made in this announcement are forward-looking statements, including with respect to the anticipated timing of completion of enrolment of the Company's Phase 2 trial of topical ocular OK-101 to treat DED and the release of top-line data therefrom. 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. 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.

本公告中的某些陈述是前瞻性陈述,包括关于公司治疗勃起障碍的局部眼部注射 OK-101 第二阶段试验的预计完成时间以及由此发布的主要数据。这些前瞻性陈述不是历史事实,而是基于公司当前对其行业、信念和假设的预期、估计和预测。诸如 “预期”、“期望”、“打算”、“计划”、“相信”、“寻求”、“估计” 等词语以及类似的表述旨在识别前瞻性陈述。这些陈述不能保证未来的业绩,并受已知和未知的风险、不确定性和其他因素的影响,其中一些因素是公司无法控制的,难以预测,并可能导致实际业绩与前瞻性陈述中表达或预测的结果存在重大差异。公司提醒证券持有人和潜在证券持有人不要过分依赖这些前瞻性陈述,这些陈述仅反映公司截至本公告发布之日的观点。本公告中的前瞻性陈述仅涉及截至陈述发表之日的事件。除非法律或任何适当的监管机构要求,否则公司不承担任何义务公开发布对这些前瞻性陈述的任何修订或更新,以反映本公告发布之日之后发生的事件、情况或意外事件。

Enquiries:

查询:

OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer 917-497-7560
Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379
OKYO 制药有限公司 Gary S. Jacob,首席执行官 917-497-7560
业务发展与投资者关系 保罗斯宾塞 +44 (0) 20 7495 2379
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