Gabapentin

Phase 2 randomized, placebo-controlled trial in neuropathic corneal pain (NCP) patients planned to begin in Q3, 2024OK-101 is believed to be 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 needOK-101 demonstrated statistically significant pain relief as measured by visual analogue scale (VAS) from Day 29 through the last study visit at Day 85 in a Phase 2 trial of dry eye disease, as well as reduced neuropathic corneal pain (NCP) in a preclinical mouse modelNCP is an Orphan disease as listed in the National Organization for Rare Disorders LONDON and NEW YORK, July 11, 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 anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today its plan to advance OK-101 into a Phase 2 clinical trial of neuropathic corneal pain which is expected to begin in Q3 2024. This one-year study is supported by pre-clinical animal model data and statistically significant pain relief observed in OK-101’s first human trial recently conducted in DED patients. The Phase 2 NCP trial will be conducted at a single-center and 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, 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 looking forward to rigorously evaluating OK-101’s potential in treating pain symptoms in patients suffering from neuropathic corneal pain,” said Dr. Hamrah. “We have designed an effective protocol to test our hypothesis in this patient population after productive FDA interactions and we will be closely overseeing the conduct of this trial at Tufts Medical Center.” “We believe that OK-101 is the first NCP drug candidate to have received FDA IND clearance for clinical evaluation and are pleased to be making rapid progress to advance the NCP program while working to refine the study design for our upcoming trial in DED,” said Dr. Gary S. Jacob, Ph.D., CEO of OKYO. “The favorable improvements in ocular pain in dry eye patients, a percentage of whom suffer from NCP, along with the impressive results from a preclinical model of NCP are encouraging signs as we look for a positive result in this upcoming Phase 2 trial in NCP. Notably, OK-101 targets a receptor found in neurons and glial cells. NCP is an acutely painful ocular disease with no FDA-approved therapy. We are hoping to deliver an exciting innovation to this ophthalmic unmet need.” The Phase 2 NCP study is designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in 48 NCP patients whose disease has been diagnosed by confocal microscopy. The primary endpoint for the study is pain improvement measured by VAS compared to placebo. There will be a total of five study visits over the course of 16 weeks, which includes a follow-up visit four weeks after completion. In a recently completed Phase 2 trial of DED patients, there was a statistically significant and durable improvement in pain, blurred vision, and burning/stinging as measured by VAS beginning on Day 29, Day 15 and Day 15, respectively, and through the last study visit at Day 85. Additionally, there was a significant improvement in pain scores as measured by patient reported daily diaries observed as early as within the first two weeks of treatment and through the last study visit at Day 85. Furthermore, in a preclinical mouse model, OK-101 reduced corneal pain response comparably to gabapentin on Day 14 post-surgery. For additional details, please refer to the slides in the issued Form 6-K filing. About NCPNeuropathic corneal pain (NCP) is a condition that causes pain and sensitivity of the eyes, face, or head. The exact cause of NCP is unknown but thought to result from nerve damage to the cornea combined with inflammation. NCP, which can exhibit as a severe, chronic, or debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. There are no approved commercial treatments currently available for this condition. About OK-101OK-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 OKYOOKYO 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 StatementsCertain 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 LimitedGary S. Jacob, Chief Executive Officer917-497-7560Business Development & Investor RelationsPaul Spencer+44 (0)20 7495 2379

7月5日，药监局网站显示，海思科苯磺酸克利加巴林胶囊获批新适应症，用于带状疱疹后遗神经痛（PHN）。 克利加巴林胶囊是一款抑制性神经递质γ-氨基丁酸（GABA）的结构衍生物，可以与钙离子通道α2δ亚受体结合，具备高靶点选择性、强效镇痛、长效镇痛、中枢副作用小等特点，对中至重度患者疗效可能更佳。今年5月，该产品首次获得批准上市，用于成人糖尿病性周围神经病理性疼痛，商品名为思美宁。 PHN是周围神经病理性疼痛的一种常见类型，我国约有400万PHN患者。临床上推荐PHN一线治疗的药物均为钙离子通道调节剂普瑞巴林和加巴喷丁，但二者在临床使用中均需滴定给药（即需先服用小剂量一段时间，耐受后再逐步增加至治疗剂量），且存在疗效不佳、不良反应发生率高等多种不足。因此，亟需研发新型药物为PHN患者提供安全有效的新治疗选择。 PHN确证性临床试验数据统计结果显示，克利加巴林胶囊在统计意义上达到主要疗效终点，整体安全性均良好可控。海思科表示，克利加巴林胶囊给药过程无需滴定，有更优的安全性和有效性，具有成为周围神经病理性疼痛首选用药的潜力。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。 免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。