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

Rhea-AI Summary

OKYO Pharma (NASDAQ: OKYO) announces the release of new efficacy data from the Phase 2 trial of OK-101 in dry eye disease, showing significant improvements in FDA-recognized endpoints. The company plans to advance OK-101 into Phase 3 trials in 2024 and evaluate its potential for treating neuropathic corneal pain.

Medical Research Analyst

The upcoming efficacy data from the Phase 2 trial of OK-101 by OKYO Pharma Limited is a significant development in the field of ocular therapies, specifically for inflammatory dry eye disease (DED) and neuropathic corneal pain (NCP). The announcement that the data will be released soon, coupled with the fact that the preliminary data showed statistically significant drug effects, is likely to generate interest among investors and industry stakeholders.

From a medical research standpoint, the progression to Phase 3 trials indicates a level of confidence in the drug's potential efficacy and safety profile. The differentiation of OK-101 from existing treatments could address a substantial unmet need in DED patients, potentially leading to a competitive advantage in the multi-billion-dollar DED market.

Furthermore, the treatment of NCP represents a frontier in ocular therapy, as there are currently no FDA-approved treatments for this condition. The IND clearance for clinical studies in this area could open up a new market segment for OKYO Pharma, pending successful trial outcomes.

Financial Analyst

The biopharmaceutical sector is closely watched by investors, especially when it comes to clinical-stage companies like OKYO Pharma that are on the verge of potentially breakthrough therapies. The Phase 2 trial results for OK-101 are particularly noteworthy due to the drug's target market—DED and NCP—which are areas with high patient demand and insufficient treatment options.

Investors will be paying attention to the comprehensive efficacy data readout, as positive results could lead to a surge in OKYO Pharma's stock price. The anticipation of Phase 3 trials is also a positive indicator of the drug's progress through the regulatory pipeline, which could further drive investor confidence if the trials are successful. The company's strategic focus on both DED and NCP suggests a dual revenue stream potential in the long term. However, the inherent risks of clinical trials and the regulatory approval process should be considered when evaluating the company's future financial health.

Pharmaceutical Market Analyst

In analyzing the impact of OKYO Pharma's announcement on the pharmaceutical market, it's important to consider the prevalence and economic burden of DED and NCP. The DED market is not only large but also growing, due to factors such as an aging population and increased screen time. OK-101's progress into Phase 3 clinical trials signals a potential shift in the standard of care for DED, provided the efficacy and safety data continue to be favorable.

The fact that OKYO Pharma is hosting a Key Opinion Leader (KOL) event to discuss the findings suggests a strategic move to build credibility and awareness within the medical community. This could facilitate quicker adoption and integration into treatment protocols if the drug reaches the market. For NCP, the lack of current treatments creates an opportunity for OKYO Pharma to establish itself as a pioneer in a new therapeutic area. Investors and market analysts should monitor the company's ability to capitalize on these opportunities.

LONDON and NEW YORK, March 20, 2024 (GLOBE NEWSWIRE) -- 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.

Enquiries:

OKYO Pharma Limited	Gary S. Jacob, Chief Executive Officer	917-497-7560
Business Development & Investor Relations	Paul Spencer	+44 (0)20 7495 2379

What is the ticker symbol for OKYO Pharma ?

The ticker symbol for OKYO Pharma is OKYO.

What is the focus of OKYO Pharma 's clinical development?

OKYO Pharma is developing innovative ocular therapies for inflammatory dry eye disease and anterior ocular segment diseases, including neuropathic corneal pain.

When will OKYO Pharma release new efficacy data from the Phase 2 trial of OK-101?

OKYO Pharma will release new efficacy data from the Phase 2 trial of OK-101 on March 22, 2024.

What were the key findings from the preliminary data readout of OK-101?

The preliminary data readout of OK-101 showed statistically significant drug effects in FDA-recognized efficacy endpoints, including improvements in conjunctival staining, burning/stinging, and blurred vision.

What is the goal of advancing OK-101 into Phase 3 trials in 2024?

The goal of advancing OK-101 into Phase 3 trials in 2024 is to develop a highly differentiated dry eye product to help patients underserved by current treatments.

What type of trial was conducted for OK-101 in DED patients?

A double-masked, randomized, placebo-controlled Phase 2 trial was conducted for OK-101 in DED patients at six sites in the U.S., enrolling 240 subjects dosed twice-daily.

How many cohorts were there in the Phase 2 trial of OK-101?

There were three cohorts in the Phase 2 trial of OK-101, with varying concentrations of the drug and a placebo group.

What is the duration of a patient's treatment in the Phase 2 trial of OK-101?

The duration of a patient's treatment in the Phase 2 trial of OK-101 was 14 weeks, including a 2-week run-in period on placebo.

What is the parallel development focus for OK-101 in 2024?

The parallel development focus for OK-101 in 2024 is the evaluation of the drug candidate to treat neuropathic corneal pain, for which IND clearance has been received to begin clinical studies.