OK-101 is the first IND clearance granted by FDA for a drug to begin clinical studies specifically to treat patients suffering with neuropathic corneal pain (NCP), a major unmet medical need
The initial trial of OK-101 to treat NCP is designed as a randomized, placebo-controlled, double-masked Phase 2 clinical trial and is planned to begin in 2Q 2024
NCP is an Orphan disease as listed in the National Organization for Rare Disorders
LONDON and NEW YORK, Feb. 09, 2024 (GLOBE NEWSWIRE) -- 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 for neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today that the U.S. Food and Drug Administration (FDA) has cleared OK-101 as its first Investigational New Drug (IND) application for the treatment of NCP.
Notably, the initial IND submission to FDA proposed an open-label design for the clinical trial. Based on positive feedback from FDA, the Phase 2 study is now designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients. A total of 54 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary endpoint will be measured utilizing VAS pain relief scores. These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms. OKYO Pharma is scheduling this trial to begin in Q2 2024.
The OK-101 trial, designed as a single-center trial, will be led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. An ophthalmologist and a clinician-scientist, Dr. Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is also a member of OKYO’s Scientific Advisory Board.
“I am very pleased that we have gained FDA IND clearance for the first drug to be tested for NCP, a debilitating disease,” said Dr. Hamrah. “Receiving the IND clearance in an important and novel indication was not a trivial hurdle to overcome. Now that the path has been opened for drugs to be tested in NCP, I am looking forward to working with the OKYO team to launch this important trial.”
“We are pleased to gain IND clearance for OK-101 to treat NCP as a second important disease target for the Company,” said Dr. Gary S. Jacob, CEO of OKYO. “OK-101 recently demonstrated favorable tolerability in a Phase 2 trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and blurred vision, which are also hallmarks of NCP. OK-101 was also shown in a cutting-edge mouse model of NCP to significantly reduce ocular neuropathic pain. We are looking forward to advancing OK-101 to potentially treat NCP, a chronically painful ocular disease with no FDA-approved therapy and a major unmet medical need for patients suffering from this condition.”
Recent OKYO News
- OKYO Pharma Announces Upcoming Presentation of OK-101 Phase 2 Data for Dry Eye Disease at the Dry Horizons Symposium, a Partner Meeting of the Association for Research in Vision and Ophthalmology (ARVO) • GlobeNewswire Inc. • 04/30/2024 11:00:00 AM
- OKYO Pharma to Reschedule Key Opinion Leader Event in Dry Eye Disease to May 2024 • GlobeNewswire Inc. • 04/08/2024 11:00:00 PM
- OKYO Pharma Announces Upcoming Presentation of OK-101 Phase 2 Data for Dry Eye Disease at Eyecelerator 2024, a Partner Meeting of the American Society for Cataract and Refractive Surgery • GlobeNewswire Inc. • 04/02/2024 11:00:00 AM
- OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101 • GlobeNewswire Inc. • 03/22/2024 11:00:00 AM
- OKYO Pharma to Host Key Opinion Leader Event to Discuss New and Comprehensive Data from Phase 2 Dry Eye Disease Trial • GlobeNewswire Inc. • 03/21/2024 11:00:00 AM
- OKYO Pharma to Release New and Comprehensive Data from Phase 2 Dry Eye Disease Trial and Host Key Opinion Leader Event • GlobeNewswire Inc. • 03/20/2024 11:00:00 AM
- OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain • InvestorsHub NewsWire • 02/09/2024 12:36:59 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/09/2024 12:00:36 PM
- OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain • GlobeNewswire Inc. • 02/09/2024 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/31/2024 12:00:20 PM
- OKYO Pharma Announces Distinguished Ophthalmologists with Expertise in the Medical and Surgical Treatment of Ocular Surface Diseases Join its Scientific Advisory Board • GlobeNewswire Inc. • 01/31/2024 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/08/2024 12:00:33 PM
- OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Both Sign and Symptom Endpoints in its First-in-Human Phase 2 Trial of OK-101 in Patients with Dry Eye Disease • GlobeNewswire Inc. • 01/08/2024 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/05/2024 02:30:06 PM
- OKYO Pharma to Present at the Biotech Showcase Conference in San Francisco, January 8-10, 2024 • GlobeNewswire Inc. • 01/05/2024 02:30:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/21/2023 12:35:34 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 12/20/2023 10:30:30 PM
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- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/04/2023 12:00:18 PM
- OKYO Pharma Announces Last Patient Enrolled in OK-101 Phase 2 Clinical Trial to Treat Dry Eye Disease Has Completed Final Protocol Visit • GlobeNewswire Inc. • 12/04/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/29/2023 12:00:36 PM
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- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 10/31/2023 08:59:54 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 10/31/2023 11:00:14 AM
- OKYO Pharma Announces $5.84 Million Cash Raise and Payables Reduction • GlobeNewswire Inc. • 10/31/2023 11:00:00 AM
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