–Phase 2 OK-101 efficacy data to be released March 22, 2024-
London and New York, NY, March 20, 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 releasing new and comprehensive efficacy data readout from the Phase 2 trial of OK-101 in dry eye disease on March 22, 2024. The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.
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.
The KOL call will feature prominent experts in the field of dry eye disease. The speakers will provide insights regarding the clinical significance of the OK-101 Phase 2 findings and discuss the potential implications for patient care and future research endeavors in DED.
"The upcoming data release follows the successful completion of OKYO Pharma's Phase 2 trial, which focused on assessing the efficacy and safety of OK-101, our novel topical therapeutic candidate for dry eye disease," said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. "We plan to advance OK-101 into Phase 3 clinical trials in 2024, with the goal of developing a highly differentiated dry eye product to help patients underserved by current treatments. Our parallel development focus for OK-101 in 2024 is the evaluation of this drug candidate to treat neuropathic corneal pain for which we have already received IND clearance to begin clinical studies."
OK-101 Phase 2 Trial in DED Patients
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.
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 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.
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 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.
Forward-Looking Statements
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.
「今度のデータ発表は、ドライアイ疾患の新しい局所治療薬候補であるOK-101の有効性と安全性の評価に焦点を当てたOKYO Pharmaの第2相試験が無事終了したことに続くものです」と、OKYO PharmaのCEOであるGary S. Jacob博士は述べました。「私たちは、現在の治療法では十分な治療を受けていない患者を支援する、高度に差別化されたドライアイ製品を開発することを目標に、2024年にOK-101を第3相臨床試験に進める予定です。2024年に予定されているOK-101と並行して開発しているのは、神経障害性角膜痛の治療薬候補の評価です。この薬剤については、すでにINDの認可を受けて臨床研究を開始しています。」
