Full Press Release Details
Pharma to Complete Enrollment of Neuropathic Corneal Pain Trial by End of Second Quarter
and New York, NY, January 29, 2025 - 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.
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.
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.
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.
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.
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.
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).
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.
is planning to engage with the FDA on the next clinical plans for OK-101 to treat DED.
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.
| 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 |