OKYO - OKYO Pharma To Begin Phase 2 Efficacy Trials For Dry Eye Disease Drug Candidate In March 2023 Anticipates Releasing Topline Results By Q4
(NewsDirect)
By David Willey, Benzinga
Drug development isn’tknown for being fast-paced, and developing any new drug is generally along process. However, OKYO Pharma Ltd. (NASDAQ: OKYO) ismoving quickly to develop its eye treatment drug, OK-101. It plans tobegin trials for the drug in the 2nd quarter of 2023.
OKYO Pharma is abiopharmaceutical company developing a treatment for Dry Eye Disease(DED). DED, a common disease often associated with aging, results inimpaired vision, pain and eyesight fatigue. Treatments for DEDcurrently cost healthcare systems and patients over$50 billion annually, and no drugs on the market are fullyeffective.
OKYOPharma is developing a novel treatment for DED and plans on initiatinga phase 2 efficacy trial for OK-101 within the next 1-3 months. Thecompany anticipates releasing topline data on its 240-patient trial inDED patients by the fourth quarter of 2023. If the trial meets itspre-specified endpoints, the timeline for the drug’s approval couldbe significantly accelerated.
Food and Drug Administration (FDA)-approvedtreatments are notoriously slow to develop and require two wellcontrolled double-blind registration phase 3 trials as the majorsupport for drug approval. Collecting thise data for a new drugapplication (NDA) with the FDA normally involves three phases ofclinical trials. Phase 1 is conducted solely with volunteers, andtests for drug safety. Phase 2 includes patients but typically startswith dose escalation studies for building data around safety. Finally,phase 3 involves two registration trials, where the focus is onestablishing drug efficacy and further building support for drugsafety. It typically takes an average of 10years for companies to go from an initial concept performed inanimal studies to get all the way to FDA approval, and it sometimeseven takes much longer than that.
OKYOPharma, which was founded in 2018, will have efficacy data availableby the end of this year, meaning it may be in a position to getapproval with only five or so years of drug development. OKYO is ableto move fast with its drug development because the treatment isdelivered topically as eye drops, so it doesn’t risk getting intothe blood and has virtually no systemic exposure, and the company isadditionally designing the clinical phase 2 trial with the inclusionof pre-specified primary endpoints, a hallmark of phase 3 trials.
Phase 2 Efficacy Trial Begins March 2023
OKYO Pharma filed anInvestigational New Drug (IND) application in November, and nowit's starting a phase 2 efficacy trial on DED patients in the 2nd quarter of 2023.The trial will be conducted as a double-blind placebo-controlledtrialtrial with the inclusion of pre-specified primary endpoints,meaning the data collected here could count towards its registrationtrials. The company has said it’s conducting these trials throughthe contract research organization (CRO) Ora Inc. Ora is aworld-class ophthalmologically-focused CRO. It has seen over 50 productapprovals and has been involved in developing threeFDA-approved ocular drugs.
OKYO Pharma is led by Dr. Gary S. Jacob, who has aproven track record of drug development and has already brought twoFDA drugs to market. Dr. Jacob has also remarked on the solidintellectual property (IP) estate for the drug, including patentsissued on the drug composition and its use to treat DED patients. Thecompany views this IP estate as an important component of the OK-101franchise. It serves to ensure drug exclusivity should the companyeventually seek a merger or acquisition as it continues to develop andmarket the drug.
Preliminarypreclinical trials in animals suggest OK-101 iseffective at both reducing ocular inflammation and decreasing thecorneal neuropathic pain that comes from nerve damage. The drug worksby latching onto an ocular immune cell receptor, ChemR23. Thisreceptor protects the eyes from infection by activating apro-inflammatory response. Often this is good, but DED causes chronicinflammation which can lead to serious damage to the cornea as well asto the ocular nerves. OK-101 has a modified chemerin that includes a9-mer highly-stable peptide. This peptide binds to the receptor,initiating an anti-inflammatory response in the eye, as well asdecreasing the ocular pain.
Comparable companies in the ocular and retinaldisease space include Aldeyra Therapeutics (NASDAQ: ALDX), Ocular Therapeutix (NASDAQ: OCUL) and Tarsus Pharmaceuticals (NASDAQ: TARS).
Want to learn more about OKYO Pharma? Visit its website .
This article wasoriginally published on Benzinga here .
OKYOPharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences companyadmitted to listing on NASDAQ and on the standard segment of theOfficial List of the UK Financial Conduct Authority and to trading onthe main market for listed securities of London Stock Exchange plc.OKYO is focusing on the discovery and development of novel moleculesto treat inflammatory dry eye diseases and chronicpain.
Certain statements made in this announcement areforward-looking statements. These forward-looking statements are nothistorical facts but rather are based on the Company’s currentexpectations, estimates, and projections about its industry; itsbeliefs; and assumptions. Words such as ‘anticipates,’‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’‘seeks,’ ‘estimates,’ and similar expressions are intended toidentify forward-looking statements. These statements are notguarantees of future performance and are subject to known and unknownrisks, uncertainties, and other factors, some of which are beyond theCompany’s control, are difficult to predict, and could cause actualresults to differ materially from those expressed or forecasted in theforward-looking statements. The Company cautions security holders andprospective security holders not to place undue reliance on theseforward-looking statements, which reflect the view of the Company onlyas of the date of this announcement. The forward-looking statementsmade in this announcement relate only to events as of the date onwhich the statements are made. The Company will not undertake anyobligation to release publicly any revisions or updates to theseforward-looking statements to reflect events, circumstances, orunanticipated events occurring after the date of this announcementexcept as required by law or by any appropriate regulatoryauthority.
This post contains sponsored advertising content.This content is for informational purposes only and is not intended tobe investing advice.
ContactDetails
Christine Petraglia - TraDigital IR
CompanyWebsite
Copyright (c) 2023 TheNewswire - All rights reserved.