OKYO Pharma provides clinical updates on its Phase 2 trials for neuropathic corneal pain and dry eye disease treatments.
Quiver AI Summary
OKYO Pharma Limited, a clinical-stage biopharmaceutical company listed on NASDAQ, reported clinical updates and interim financial results as of September 30, 2024. The company is developing OK-101, an innovative treatment for neuropathic corneal pain (NCP), with enrollment for a 48-patient Phase 2a trial expected to finish by the end of the second quarter of 2025, and top-line results anticipated in the fourth quarter of 2025. OK-101 has received FDA investigational new drug clearance and aims to address the severe pain caused by corneal nerve damage, a condition lacking approved treatments. Furthermore, the company shared positive results from an earlier Phase 2b trial of OK-101 for inflammatory dry eye disease (DED), showing significant clinical benefits and a favorable safety profile. Financially, OKYO reported total assets of $2.8 million and a comprehensive loss of $3.1 million for the reviewed period, reflecting an improvement compared to the previous year.
Potential Positives
- Announcement of successful clearance of IND by the FDA for OK-101, allowing the first clinical evaluation of a drug targeting neuropathic corneal pain (NCP).
- Positive top-line data reported from the Phase 2b trial of OK-101 for dry eye disease (DED), establishing a clear pathway for further clinical development.
- Improvement in multiple symptom endpoints for DED patients, indicating the potential efficacy of OK-101.
- Reduction in total comprehensive loss to $3.1 million compared to $8.5 million in the same period last year, reflecting better financial performance.
Potential Negatives
- The company reported a total comprehensive loss of $3.1 million during the financial period, despite an improvement from a loss of $8.5 million in the same period the previous year, indicating ongoing financial challenges.
- With only $1.0 million in cash on hand as of the financial report date and limited assets, the company may face liquidity issues, which could impact its ability to fund ongoing clinical trials and operations.
- The upcoming completion of enrollment in the NCP trial does not guarantee positive results, making the anticipated data release a major binary event that could result in significant stock volatility if the outcomes are unfavorable.
FAQ
What is OKYO Pharma Limited's primary focus for clinical development?
OKYO Pharma is focused on developing therapies for neuropathic corneal pain and inflammatory dry eye disease.
What are the interim results for the OK-101 clinical trial?
The interim results indicate progress towards completing enrollment in the Phase 2a trial for neuropathic corneal pain.
When will the top-line data for OK-101 be released?
Top-line data for the Phase 2a trial of OK-101 is anticipated to be released in Q4 2025.
What milestones has OKYO Pharma achieved for OK-101?
OKYO Pharma achieved FDA IND clearance for OK-101 and positive top-line data from a Phase 2b trial in DED.
Who is leading the clinical trial for OK-101?
Dr. Pedram Hamrah of Tufts Medical Center is the Principal Investigator leading the OK-101 clinical trial.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$OKYO Hedge Fund Activity
We have seen 1 institutional investors add shares of $OKYO stock to their portfolio, and 3 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CITADEL ADVISORS LLC added 14,876 shares (+inf%) to their portfolio in Q3 2024, for an estimated $15,173
- HSBC HOLDINGS PLC removed 11,933 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $12,171
- SUSQUEHANNA INTERNATIONAL GROUP, LLP removed 11,123 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $11,345
- UBS GROUP AG removed 1,379 shares (-72.4%) from their portfolio in Q3 2024, for an estimated $1,406
- BARCLAYS PLC added 0 shares (+0.0%) to their portfolio in Q3 2024, for an estimated $0
- CONTINUUM ADVISORY, LLC added 0 shares (+0.0%) to their portfolio in Q3 2024, for an estimated $0
- GEODE CAPITAL MANAGEMENT, LLC added 0 shares (+0.0%) to their portfolio in Q3 2024, for an estimated $0
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
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.
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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
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