Pisd
5月前
OKYO Pharma Announces Successful Type C Meeting with the FDA
OKYO Pharma LTD
Wed, January 28, 2026 at 7:40 AM EST 5 min read
In this article:
OKYO
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OKYO Pharma LTD
OKYO Pharma LTD
FDA confirms Phase 2b/3 clinical design, including primary endpoint, sample size and development approach
LONDON and NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that it held a successful Type C meeting with the Food & Drug Administration (FDA) regarding the Phase 2b/3 human clinical trial of urcosimod for the treatment of neuropathic corneal pain (NCP).
Key highlights from the Type C FDA meeting include:
FDA confirms the approach that the proposed primary endpoint of the Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, including explicit acknowledgment that a ≥2-point improvement on the VAS scale represents a meaningful treatment effect
The Agency provided statistical guidance to enhance robustness, noting that if the statistical analysis plan (SAP) is finalized prior to unmasking and results are strong, the data could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting
FDA endorsed the proposed study design, sample size, and powering assumptions, and agreed that the Ocular Pain Assessment Survey (OPAS) is appropriate as supportive quality-of-life evidence
FDA alignment on the Chemistry, Manufacturing and Controls (CMC) strategy and key clinical elements, with no material issues raised, derisking the pathway to a pivotal trial and supports potential registration if study results are robust
“We were very pleased to achieve meaningful progress with the FDA toward alignment on urcosimod’s clinical development program,” said Raj Patil, Ph.D., Chief Scientific Officer at OKYO Pharma. “This alignment represents an important step forward and underscores the potential to address a significant unmet medical need in patients with neuropathic corneal pain.”
“I want to thank the entire OKYO team for their focus, rigor, and collaboration that led to this successful Type C meeting with the FDA,” said Robert Dempsey, CEO of OKYO Pharma. “This positive outcome reflects years of disciplined scientific and clinical execution; moreover, the FDA’s alignment on our Phase 2b/3 strategy meaningfully de-risks the program. The results of this meeting also represent a meaningful value-inflection point for urcosimod and, most importantly, a step forward for patients suffering from neuropathic corneal pain, where the unmet need remains profound.”
As previously communicated, urcosimod was granted the first IND to treat patients with NCP and was awarded fast track designation by the Food and Drug Administration (FDA). The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
About Neuropathic Corneal Pain (NCP)
Neuropathic corneal pain (NCP) is a chronic, often debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of corneal sensory nerves, often in combination with inflammatory processes, and may occur in patients with a range of underlying ophthalmic conditions. There are currently no FDA-approved therapies specifically for NCP, resulting in patients being treated with limited or no success using various topical and systemic medications in an off-label manner.
About Urcosimod (formerly called OK-101)
Urcosimod 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, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2 trial involving 18 neuropathic corneal pain patients. Urcosimod showed clear statistical significance in multiple endpoints in an earlier 240-patient Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.
About OKYO Pharma
OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in patients with NCP and plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.
Gator44
12月前
OKYO 2.70 https://stockcharts.com/sc3/ui/?s=OKYO
https://finviz.com/quote.ashx?t=OKYO&p=d
Goldman Small Cap Research Issues New Research Update on OKYO Pharma Limited
(ACCESSWIRE)
Raising Price Target Due to Fundamental Drivers
BALTIMORE, MD / ACCESS Newswire / June 11, 2025 / Goldman Small Cap Research, a stock market research firm specializing in the small cap and microcap sectors, announced today that it has published a new research update on OKYO Pharma Limited (NASDAQ:OKYO), an emerging player in the fast-growing ophthalmic drugs segment. The Goldman report carries a price target. To view the new research update, previous OKYO reports, along with disclosures and disclaimers, or to download the update in its entirety, please visit: https://goldmansmallcapresearch.com/opportunity-research/raising-price-target-to-8/
OKYO Pharma Limited Is a clinical stage bio-pharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and dry eye disease (DED), with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO's lead drug candidate successfully completed a 240-patient Phase 2 trial in DED patients and completed a 17-patient Phase 2 trial in NCP patients. OKYO elected to lose the trial early. The implications of the early trial completion plus desire to immediately analyze clinical results and release top-line data in 3Q25 suggest potential, immediate outcomes, pending positive top-line results, in our view.
In the Opportunity Research update, analyst Rob Goldman reviews recent share performance, clinical achievements, upcoming milestones and why recent and pending events prompted us to raise our price target for OKYO.
OKYO: A Stellar Performer
Goldman commented, "Since our January 2025 report, OKYO's shares have essentially doubled, along with a doubling of average daily volume. Plus, the shares have set a new 52-week high."
Early Closure of Phase 2 Trial is a Major Plus
"In our view, share price rise has been driven by fundamental developments, including the receipt of Fast Track designation for its lead candidate urcosimod, and the unexpected early completion of its Phase 2 trial," noted Goldman. "The early trial closure potentially shortens OKYO's development pathway as top-line results are slated to be released in 3Q25, months earlier than originally forecasted. A key takeaway is that the acceleration of the release of potentially positive top-line Phase 2 data should also shorten the time that we believe these shares would take to reach our upgraded, $8.00 price target, up from $5.00, previously."
Substantial Potential Opportunity
"As a first-mover that has the potential to publish favorable results for a debilitating condition that has a serious unmet need, and represents a multi-billion-dollar market, we believe these shares could reach new heights. Furthermore, we believe that given the M&A activity in the ocular space, a deal with a partner could occur, and that the Company would benefit from the aforementioned re-valuation of these shares," concluded Goldman.
About Goldman Small Cap Research: Founded in 2009 by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and microcap stock research reports, articles, stock market blogs, and popular investment newsletters.
Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.
This press release contains excerpts of our most recently published company report on OKYO Pharma Limited ("The Company"). The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research relied solely upon information derived from OKYO Pharma Limited. The information includes authorized press releases or legal disclosures made in their filings with the U.S. Securities and Exchange Commission http://www.sec.gov.
Separate from the factual content of our update about the Company, we may from time to time include our own opinions about the Company, its business, markets, and opportunities. Any opinions we may offer about the Company are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.
A Goldman Small Cap Research report, update, newsletter, article, trading alert, corporate profile, sector or industry snapshot, podcast interview, or press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed and is to be used for informational purposes only. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other regulatory agency. To download this research update visit www.goldmansmallcapresearch.com. Goldman Small Cap Research did not receive any compensation for this update. In January 2025, Goldman Small Cap Research was compensated by the Company in the amount of $4000 for a research report production and distribution, including a press release. In 2023, Goldman Small Cap Research (GSCR) was compensated by a third party (TraDigital Marketing Group, Inc.) in the amount of $4000 for research report production and a press release.
SOURCE: Goldman Small Cap Research
View the original press release on ACCESS Newswire
subslover
1年前
OKYO Pharma to Complete Enrollment of Neuropathic Corneal Pain Trial by End of Second Quarter
LONDON and NEW YORK, Jan. 29, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, today announces a clinical update and its interim results for the six months ended 30 September 2024.
Clinical Updates:
OK-101
Neuropathic Corneal Pain (NCP)
The Company anticipates completing enrollment of the 48-patient trial by the end of 2Q 2025 and releasing top-line data on the Phase 2a trial in 4Q 2025. Results from this trial are anticipated to be a major binary event for the Company.
During the past six months of 2024 the OKYO Pharma’s primary focus has been centered on preparations for and the initiation of the first clinical trial of a drug to treat NCP, with the announcement on 23 October, 2024 of the opening of a Phase 2a trial of OK-101 to treat NCP. The Phase 2a study is designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients. A total of 48 patients are planned to be enrolled in the trial, with NCP disease confirmed via confocal microscopy, patient symptoms and medical histories.
OK-101, a novel, non-opioid therapeutic candidate, is designed to target and alleviate the debilitating pain associated with corneal nerve damage, a condition for which there are currently no U.S. Food and Drug Administration (FDA) approved treatments. Neuropathic corneal pain, often resulting from conditions like dry eye disease, surgery, or infections, can severely impact a patient’s quality of life, with current management options limited to pain relief strategies that offer only partial or temporary respite.
Earlier in the year, in February 2024, the Company announced that it was the first company to receive an investigational new drug (IND) application clearance by FDA to clinically evaluate a drug specifically to treat NCP with the clearance of the IND for OK-101.
The OK-101 trial is designed as a single-center trial and is being led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. He is one of the world’s foremost experts on NCP and treats patients with ocular pain from across the United States and worldwide. His previous research has demonstrated safety and efficacy of various topical and systemic treatments for ocular pain and has led to the development of new diagnostic markers for ocular pain by in vivo confocal microscopy. In addition to his work on OK-101, of which he is a co-inventor and member of OKYO’s Scientific Advisory Board, Dr. Hamrah is also conducting studies on developing new corneal nerve function tests and is a consultant to the company covering non-clinical studies of OK-101 to evaluate its mechanism of action.
Dry Eye Disease (DED)
In January of 2024, OKYO reported positive top line data from the Phase 2b trial of OK-101 to treat DED patients. This OK-101 first-in-human Phase 2b trial established a clear clinical path for potential further clinical development via a Phase 3 study design using FDA-recognized endpoints. OK-101 demonstrated statistically significant benefit in a “sign” endpoint, namely “total conjunctival staining” as measured by the Ora Calibra© Staining Scale as early as Day 29 (p = 0.034). OK-101 also improved at least two “symptom” endpoints of DED, including “burning/stinging” as measured by the Ora Calibra© 4-symptom questionnaire, and as measured by a visual analog scale as early as Day 15 (p = 0.04 and p=0.03, respectively), as well as “blurred vision”, with statistically significant improvement in blurred vision occurring by Day 29 (p = 0.01).
Of the 240 patients treated in the trial, treatment emergent adverse events (TEAEs) were observed to be similar to the placebo-treated group. No severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the OK-101 0.05% treatment group and 3 patients in the placebo-treated group, again highlighting the favourable safety profile of OK-101.
OKYO is planning to engage with the FDA on the next clinical plans for OK-101 to treat DED.
Financial Highlights:
Total assets of $2.8 million (31 March 2024: $1.5million)
Cash on hand of $1.0 million (31 March 2024: $0.8 million); post period end the Company received additional cash of $1.8 million.
During the financial period under review, the Company reported a total comprehensive loss of $3.1 million (compared to total comprehensive loss of $8.5 million for the six months ending September 30 2023)
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of NCP and DED, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat NCP and inflammatory DED. In addition to the completed Phase 2 trial of OK-101 to treat DED patients, OKYO is also currently evaluating OK-101 to treat NCP patients in a Phase 2 trial.
Enquiries:
OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer U.S. 917-497-7560
Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379
https://www.globenewswire.com/newsroom/ti?nf=OTM0OTQ5MCM2NzI1NjQ0IzIyMDE0NDM=
https://ml.globenewswire.com/media/MTU5YTQ5MjctNGNiOC00NDQ1LWE3NDEtMDkyYzQzNjI0YWVjLTEyMTI5OTY=/tiny/OKYO-
Pisd
2年前
OKYO Pharma Granted European Patent Covering OK-101 Chemerin Analogs and Their Method of Use
August 06 2024 - 7:00AM
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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, announced today the grant of a key European Patent entitled: “Compositions Comprising Chemerin Analogs and Methods of Use”. The present disclosure that lists Raj Patil, Chief Scientific Officer of OKYO Pharma as a joint Inventor, relates to novel OK-101 chemerin analogs for use in treating various diseases and conditions including but not limited to, ocular inflammatory and pain conditions, strengthening the Company’s intellectual property position in this field.
"We are delighted with the issuance of this European patent, which underscores the innovative nature of our OK-101 chemerin analogs and their therapeutic potential. This milestone strengthens our intellectual property portfolio and positions OKYO Pharma for continued advancement in addressing significant unmet medical needs," commented Dr. Gary S. Jacob, Ph.D., CEO of OKYO. “The issuance of this patent further solidifies OKYO Pharma's commitment to advancing novel therapies that aim to improve outcomes for patients suffering from ocular pain and inflammation. The company continues to explore strategic partnerships and collaborations to accelerate the development and commercialization of its pipeline candidates.”
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. 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. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 20-F, for the fiscal year ended March 31, 2023. 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
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