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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將舉辦關鍵意見領袖活動,討論2期乾眼病試驗的新綜合數據
OKYO Pharma ·  03/21 00:00

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

第二階段 OK-101 療效數據將於 2024 年 3 月 22 日公佈-

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

-KOL 活動將於美國東部時間 2024 年 4 月 9 日中午 12 點舉行-

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.

倫敦和紐約州紐約,2024年3月21日——OKYO Pharma Limited(納斯達克股票代碼:OKYO)是一家臨床階段的生物製藥公司,開發創新眼部療法,用於治療價值數十億美元的市場炎症性乾眼病(DED)和前眼節疾病,包括神經病理性角膜疼痛(NCP),一種與疼痛有關但未獲美國食品藥品管理局批准的療法的眼部疾病。它將在美國東部時間2024年4月9日中午12點舉辦關鍵意見領袖(KOL)活動,深入討論新的全面調查結果OK-101 乾眼病二期試驗的療效數據讀出,該試驗將於 2024 年 3 月 22 日公佈。

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.

本次活動將邀請醫學博士、醫學博士傑伊·皮波斯(Jay Pepose),他將回顧該公司評估 OK-101 治療乾眼病的二期試驗的細節,以及醫學博士、MSPH Anat Galor,他將討論改善眼痛和區分 OK-101 特徵的局部治療的未得到滿足的需求。OKYO Pharma 的管理團隊也將出席,概述 OK-101 的行動機制。

Event details:

活動詳情:

Date: Tuesday, April 9th, 2024

日期:2024 年 4 月 9 日星期二

Time: 12:00 PM ET

時間:美國東部時間下午 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,醫學博士,Pepose Vision Institute創始人兼醫學總監,華盛頓大學醫學院臨床眼科教授,擁有近40年的治療醫生和廣泛發表的研究人員的經驗。他是Pepose Vision Institute的創始人兼醫學總監,也是聖路易斯華盛頓大學醫學院臨床眼科和視覺科學教授。Pepose博士積極參與臨床試驗,曾擔任30多項研究的研究員,這些研究評估了包括乾眼在內的各種眼科適應症中的新療法和技術。他發表了 200 多篇經過同行評審的文章,並曾在多家著名眼科期刊的編輯委員會任職。Pepose 博士擁有布蘭迪斯大學神經生理學學士學位和碩士學位,並在加州大學洛杉磯分校醫學院完成了醫學博士學位課程。Pepose博士在約翰·霍普金斯大學醫學中心威爾默研究所完成了眼科住院醫師實習,並在喬治敦大學醫學中心完成了獎學金培訓。

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,醫學博士、MSPH,邁阿密大學米勒醫學院眼科教授,是一名受過角膜和葡萄膜炎培訓的專家,曾在巴斯科姆·帕爾默眼科研究所和弗吉尼亞州邁阿密醫療中心兩次任職。Galor博士在Cole Eye Cleveland診所完成了眼科住院醫師實習,在威爾默眼科研究所完成了葡萄膜炎研究金,並在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·帕爾默眼科研究所和弗吉尼亞州邁阿密負責眼表疼痛項目,她的研究重點是了解乾眼症的疼痛機制,重點是研究新的診斷和治療方式。

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.

在先前的初步數據讀取中,OK-101 早在給藥後的 15 天首次就診時,在 FDA 認可的療效終點中就顯示出具有統計學意義的藥物作用。此外,在 “體徵”(全結膜染色)和兩個 “症狀”(燒灼/刺痛和視力模糊)中均觀察到統計學上的顯著改善,這兩個 “症狀” 是美國食品藥品管理局認可的乾眼病終點。

OK-101 Phase 2 Trial in DED Patients

OK-101 針對 DED 患者的二期試驗

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.

這項雙面罩、隨機、安慰劑對照的2期試驗在美國的六個地點進行,招收了240名受試者,每天服用兩次DED(BID)。患者被隨機分爲 3 個隊列,其中一個隊列的劑量爲 0.05% 的 OK-101(n=81),第二個隊列的劑量爲 0.1% 的 OK-101(n=80),第三組使用載體(n=79)。患者的治療持續時間爲14周,包括2周的安慰劑試用期,將安慰劑反應者排除在研究之外,隨後在研究的隨機部分中爲12周。

About OK-101

關於 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 蛋白偶聯受體的脂質偶聯的 chemerin 肽激動劑,該受體通常存在於負責炎症反應的眼睛免疫細胞中。OK-101 使用膜錨肽技術開發,用於生產治療乾眼病的新型長效候選藥物。在乾眼病和角膜神經性疼痛 (NCP) 的小鼠模型中,OK-101 已被證明可分別產生抗炎和減痛的功效信號,旨在通過在藥物分子中加入脂質錨來延長 OK-101 在眼部環境中的停留時間來對抗沖洗。在最近完成的 OK-101 治療 DED 的 2 期、多中心、雙盲、安慰劑對照試驗中,OK-101 在多個終點顯示出統計學意義。

About OKYO

關於 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.

東洋製藥有限公司(納斯達克股票代碼:OKYO)是一家臨床階段的生物製藥公司,開發治療DED和NCP的創新療法,普通股在納斯達克資本市場上市交易。OKYO 專注於發現和開發用於治療炎症 DED 和眼痛的新分子。除了最近完成的二期 DED 試驗外,OKYO 還計劃啓動 OK-101 的 2 期試驗,以治療患有這種虛弱性疾病的患者的 NCP。欲了解更多信息,請訪問 www.okyopharma.com

Forward-Looking Statements

前瞻性陳述

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.

本公告中的某些陳述是前瞻性陳述,包括關於公司治療勃起障礙的局部眼部注射 OK-101 第二階段試驗的預計完成時間以及由此發佈的主要數據。這些前瞻性陳述不是歷史事實,而是基於公司當前對其行業、信念和假設的預期、估計和預測。諸如 “預期”、“期望”、“打算”、“計劃”、“相信”、“尋求”、“估計” 等詞語以及類似的表述旨在識別前瞻性陳述。這些陳述不能保證未來的業績,並受已知和未知的風險、不確定性和其他因素的影響,其中一些因素是公司無法控制的,難以預測,並可能導致實際業績與前瞻性陳述中表達或預測的結果存在重大差異。公司提醒證券持有人和潛在證券持有人不要過分依賴這些前瞻性陳述,這些陳述僅反映公司截至本公告發布之日的觀點。本公告中的前瞻性陳述僅涉及截至陳述發表之日的事件。除非法律或任何適當的監管機構要求,否則公司不承擔任何義務公開發布對這些前瞻性陳述的任何修訂或更新,以反映本公告發布之日之後發生的事件、情況或意外事件。

Enquiries:

查詢:

OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer 917-497-7560
Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379
OKYO 製藥有限公司 Gary S. Jacob,首席執行官 917-497-7560
業務發展與投資者關係 保羅斯賓塞 +44 (0) 20 7495 2379
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