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OKYO Pharma Limited develops investigational ophthalmic therapies for neuropathic corneal pain and inflammatory eye diseases. The company’s lead candidate, urcosimod, formerly OK-101, is described as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, with development centered on ocular pain and inflammation.
Recurring company updates cover urcosimod clinical data, patient-reported outcomes from a completed Phase 2 study in neuropathic corneal pain, FDA IND and Fast Track status for the NCP program, scientific advisory and ophthalmology-conference presentations, ordinary-share ownership disclosures, and purchases of Nasdaq-listed ordinary shares by company insiders.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that its GMP packaged drug OK-101 for treating dry eye disease (DED) has cleared customs in the U.S. The company is preparing for its first-in-human Phase 2 clinical trial, with randomization codes being generated and clinical sites being authorized. Anticipated timelines include the first patient visit in Q1 2023 and top-line data release in Q4 2023. OK-101 aims to address significant unmet needs in the multi-billion-dollar DED market, leveraging its unique design to enhance drug retention in the ocular environment.
OKYO Pharma has appointed Dr. Jay S. Pepose, a leading ophthalmologist, to its Scientific Advisory Board to guide clinical programs for OK-101, a treatment for dry eye disease. Dr. Pepose brings nearly 40 years of experience and a robust background in clinical trials for ophthalmic conditions. The company plans to initiate enrollment for its Phase 2 clinical trial for OK-101 within Q1 2023. This strategic appointment aims to enhance the profile of OK-101 amidst a multi-billion-dollar market with significant unmet needs. Dr. Pepose's insights on ocular inflammation and pain management are expected to drive the development of this promising therapy.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that CEO Gary S. Jacob, Ph.D., will present on the therapeutic potential of OK-101 for dry eye disease at the GPCRs-Targeted Drug Discovery Summit on February 22, 2023, in Boston. His presentation follows that of Dr. Alan Kopin, who will share insights on the discovery and testing of OK-101. Recently, OKYO received FDA clearance for its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for OK-101, aiming to address the significant unmet need in treating dry eye disease.
OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO) has announced its interim results for the six months ending September 30, 2022. The company has achieved FDA IND clearance for its Phase 2 trial of OK-101 to treat Dry Eye Disease (DED), expected to begin in Q1 2023. Financially, OKYO reported total assets of £1.6 million and cash of £0.6 million, with a comprehensive loss of £4.6 million. The company has halted further development of OK-201 to focus resources on OK-101.
OKYO Pharma Limited has received FDA clearance to start a Phase 2 clinical trial for OK-101, a treatment for Dry Eye Disease (DED). This first-in-human study will assess both efficacy endpoints relating to the signs and symptoms of DED. The trial is set to begin in Q1 2023, aiming to demonstrate OK-101's potential as a novel treatment option for patients inadequately addressed by existing medications. The company emphasizes that success in this trial could expedite the filing for a new drug application (NDA) with the FDA.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced its participation in the Biotech Showcase in San Francisco from January 9-11, 2023. The company focuses on developing OK-101 to treat dry eye disease, addressing significant unmet needs in this multi-billion-dollar market. CEO Dr. Gary Jacob and other executives will present and hold 1x1 institutional investor meetings during the event. Attendees can schedule meetings online. The event highlights OKYO's commitment to innovation in treating inflammatory dry eye diseases.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has filed a Form F-1 registration statement with the SEC for a secondary public offering of its American Depositary Shares (ADSs). Each ADS will represent 65 ordinary shares. The offering's size and price are yet to be determined and depend on market conditions. This offering, approved by shareholders at the September 2022 AGM, will allow OKYO's shares to continue trading on the LSE and NASDAQ. ThinkEquity is the sole bookrunning manager, and the offering will not be available in the EEA or UK to the public.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) appointed PKF Littlejohn LLP as its new independent auditor effective immediately. The board approved PKF for the financial year ending March 31, 2023, with re-appointment subject to shareholder approval at the next AGM in 2023. The previous auditor, Mazars LLP, confirmed no matters for the Company’s members or creditors. OKYO thanks Mazars for their service. This announcement contains inside information under UK market regulations.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has awarded Chief Scientific Officer Raj Patil 5,000,000 options with an exercise price of 6.25 pence per share, recognizing his contribution to the recent IND filing for OK-101, aimed at treating dry eye disease. The options vest immediately and have a five-year lifespan. This move highlights the company's advancement in developing therapies for the significant unmet needs in the dry eye market, which is valued in the billions. The announcement complies with UK MAR regulations.
OKYO Pharma Ltd (NASDAQ: OKYO) announced a Key Opinion Leader webinar on November 14, 2022, regarding its potential treatment, OK-101, for inflammatory dry eye disease. The event features KOL Pedram Hamrah, MD, discussing preclinical data on OK-101's efficacy. The company aims to address a significant market need in dry eye therapies and will provide updates on its Phase 2 trial for OK-101, a lipid-conjugated peptide targeting ocular pain and inflammation.