Welcome to our dedicated page for OKYO PHARMA news (Ticker: OKYO), a resource for investors and traders seeking the latest updates and insights on OKYO PHARMA stock.
Company Overview
OKYO Pharma Ltd (symbol: OKYO) is a clinical-stage biopharmaceutical company focused on developing innovative ocular therapeutics aimed at addressing unmet medical needs in inflammatory eye diseases and chronic pain. With a deep commitment to research and development, the company is at the forefront of discovering novel molecules to treat conditions such as Dry Eye Disease (DED) and Neuropathic Corneal Pain (NCP), conditions that significantly affect patients' quality of life.
Core Business and Therapeutic Focus
At its core, OKYO Pharma is dedicated to improving patient outcomes through the advancement of cutting-edge treatments. The company has strategically designed its pipeline around OK-101, a lipid conjugated chemerin peptide agonist formulated using membrane-anchored-peptide technology. This unique approach allows for enhanced efficacy by targeting the ChemR23 G-protein coupled receptor found on ocular immune cells and neurons, thereby reducing inflammation and alleviating pain. The innovative nature of OK-101 is further reinforced by a strong portfolio of intellectual property, including key European and U.S. patents that safeguard its novel compositions and methods of use.
Clinical Development and Research Strategy
OKYO Pharma operates in a research-intensive environment where each clinical trial is designed to validate both the anti-inflammatory and analgesic properties of its therapeutic candidates. The company has advanced its lead program through multiple Phase 2 studies, demonstrating promising efficacy signals in both DED and NCP patient populations. The strategic execution of these clinical trials reflects the company’s commitment to rigorous scientific evaluation and the pursuit of innovative treatments that can fill significant gaps in current therapeutic options.
Intellectual Property and Innovation
Innovation is at the heart of OKYO Pharma’s operations. The company’s dedication to developing novel ocular therapies is underpinned by a robust intellectual property strategy. With patents covering key aspects of its chemerin analog technology, OKYO Pharma not only secures its market position but also sets a high bar for research quality and scientific rigor in the industry. This strategic IP foundation enables the company to explore potential licensing and collaboration opportunities within the broader pharmaceutical landscape.
Market Position and Competitive Landscape
Positioned within the expansive and competitive fields of ophthalmology and biopharmaceutical innovation, OKYO Pharma distinguishes itself through its specialized focus on therapeutic candidates for ocular inflammation and pain management. By addressing diseases with limited or no approved treatments, such as NCP, the company secures a niche that appeals to both clinical researchers and the investment community interested in emerging biotechnologies. Its methodical approach to clinical research and product development positions the firm as an informed player in an industry marked by rapid innovation and evolving therapeutic needs.
Key Features and Business Strengths
- Innovative Therapeutic Candidates: Focus on OK-101 for conditions with significant unmet clinical needs.
- Robust Intellectual Property: Secured patents in major jurisdictions that underpin its novel compositions.
- Clinical-Stage Expertise: Proven ability to design and execute complex clinical trials in DED and NCP.
- Focused Research Strategy: Dedicated to advancing ocular therapeutics through scientifically rigorous methodologies.
Conclusion
Overall, OKYO Pharma Ltd embodies a sophisticated blend of scientific innovation and clinical expertise in the biopharmaceutical arena. Its strategic focus on developing new therapies for inflammatory ocular diseases and neuropathic pain, bolstered by robust research and intellectual property acumen, provides a comprehensive overview of its operational model. Investors and industry watchers can appreciate the depth of its R&D efforts and its potential role in transforming the treatment landscape for debilitating ocular conditions.
OKYO Pharma (NASDAQ: OKYO) has announced significant stability data for its drug candidate urcosimod, currently in Phase 2b clinical trials for Neuropathic Corneal Pain (NCP). The drug has demonstrated remarkable stability in single-use ampoules over a 2½-year period under refrigerated conditions, with stability rates of 94.8% for 0.05% concentration and 97.4% for 0.1% concentration.
The stability testing is a important requirement for FDA approval, addressing shelf-life concerns for the drug. Additionally, room temperature stability testing has shown promising early results, with 3-month stability rates at or above 100%. The company notes that single-use ampoules are increasingly preferred for ophthalmic drugs over plastic bottles, offering better sterility control for long-term daily administration.
Urcosimod is being evaluated in a randomized, placebo-controlled, double-masked trial involving 48 patients for NCP, a severe ocular condition currently lacking FDA-approved treatments. The drug has also shown potential in treating inflammatory dry eye disease (DED), a multi-billion-dollar market opportunity.
OKYO Pharma (NASDAQ: OKYO) has filed an application for Fast Track designation with the FDA for its drug urcosimod (formerly OK-101) to treat neuropathic corneal pain. This condition, affecting tens of thousands globally, is characterized by chronic, severe eye discomfort with no current FDA-approved treatment.
The company is developing urcosimod for both neuropathic corneal pain and inflammatory dry eye disease, the latter representing a multi-billion-dollar market opportunity. Fast Track designation is designed to expedite the development and review process for drugs treating serious conditions that lack FDA-approved treatments.
OKYO Pharma (NASDAQ: OKYO) announced that its lead drug candidate OK-101 has been officially assigned the United States Adopted Name (USAN) 'urcosimod'. The drug is currently in Phase 2 clinical trials for neuropathic corneal pain (NCP), a condition without FDA-approved treatments, and has shown promising results in Phase 2 trials for inflammatory dry eye disease (DED).
Urcosimod is a lipid-conjugated small molecule designed to target ocular G-protein coupled receptors (GPCRs), combining anti-inflammatory and pain-modulating properties. The ongoing Phase 2 trial for NCP, initiated in October 2024, is expected to release top-line results in Q4 2025. The suffix '-mod' in the name reflects its role as a modulator of inflammatory and neuropathic pathways.
OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on neuropathic corneal pain (NCP) and inflammatory dry eye disease (DED) treatments, has announced significant insider share purchases. CEO Gary S. Jacob acquired 10,000 ordinary shares at US$1.04 per share on NASDAQ. Additionally, Panetta Partners , connected to Executive Chairman Gabriele Cerrone, purchased 20,000 ordinary shares at the same price. Following these transactions, Cerrone's total shareholding has reached 9,871,570 shares, representing 28.96% of the company's issued share capital.
Goldman Small Cap Research has published a new research report on OKYO Pharma (NASDAQ:OKYO), highlighting its potential in the ophthalmic drugs segment. OKYO's lead drug candidate OK-101 has completed a 240-patient Phase 2 trial in Dry Eye Disease (DED) and is currently being evaluated in a 48-patient Phase 2 trial for Neuropathic Corneal Pain (NCP).
The company is notable for being the first to receive FDA approval for NCP clinical trials and launch a specific NCP patient trial. Goldman estimates the potential NCP market size at $6.4 billion, based on 160,000 US potential patients, contingent on receiving Orphan Drug designation. The report suggests OKYO could attract potential joint venture partners or acquirers in 2026/2027, with several milestones expected in 2025.
OKYO Pharma provided updates on its clinical trials and financial results for the six months ended September 30, 2024. The company expects to complete enrollment of 48 patients in its Phase 2a trial of OK-101 for Neuropathic Corneal Pain (NCP) by Q2 2025, with top-line data expected in Q4 2025.
Earlier in January 2024, OKYO reported positive top-line data from its Phase 2b trial of OK-101 for Dry Eye Disease (DED). The drug showed statistically significant benefits in total conjunctival staining by Day 29 and improved symptoms like burning/stinging and blurred vision. The safety profile was favorable, with TEAEs similar to placebo.
Financially, OKYO reported total assets of $2.8 million as of September 2024, including $1.0 million in cash, with an additional $1.8 million received post-period. The company's comprehensive loss decreased to $3.1 million compared to $8.5 million in the same period last year.
OKYO Pharma (NASDAQ: OKYO) has secured $1.4 million in non-dilutive funding to advance its innovative pipeline, particularly focusing on its lead program OK-101 for treating neuropathic corneal pain (NCP). The company, which develops therapies for NCP - a severe ocular condition without FDA-approved treatments - and inflammatory dry eye disease (DED), will use this funding to support ongoing research and development initiatives.
The funding strengthens OKYO's ability to progress its development programs without diluting shareholder value. CEO Dr. Gary S. Jacob emphasized that this financial boost will contribute significantly to their mission of developing groundbreaking treatments for ophthalmic diseases while maintaining fiscal responsibility and creating value for shareholders.
OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on treating neuropathic corneal pain and inflammatory dry eye disease, announces its participation in the 4th Annual Virtual BTIG Ophthalmology Day on December 2nd, 2024. CEO Gary S. Jacob will engage in one-on-one meetings and lead a fireside chat from 2:40-3:15pm.
The event will feature over 20 medical technology and biotechnology companies, discussing latest developments in ophthalmic technologies and therapeutics. OKYO is developing treatments for NCP, which currently lacks FDA-approved therapies, and DED, representing a multi-billion-dollar market opportunity.
RedChip Companies announces the airing of interviews with MUSQ Global Music Industry ETF (NYSE:MUSQ) and OKYO Pharma on Bloomberg TV. David Schulhof, MUSQ's Founder and CEO, discusses how their ETF provides exposure to the global music ecosystem through the MUSQ Global Music Industry Index (MUSQIX), covering music streaming, content, distribution, live events, radio, and equipment. Goldman Sachs projects industry revenue to reach $163.7B by 2030.
OKYO Pharma's CEO Gary Jacob discusses their Phase 2 clinical trial of OK-101, a novel non-opioid topical treatment for neuropathic corneal pain (NCP). The trial, initiated October 16, 2024, at Tufts Medical Center, aims to evaluate OK-101's effectiveness in treating NCP caused by dry eye disease, surgery, or infections.
OKYO Pharma (NASDAQ: OKYO) announces its participation in the 10th International Tear Film & Ocular Surface Society Conference in Venice, Italy from October 30 to November 2, 2024. The company will present results from their dry eye disease trial and discuss their ongoing Phase 2 trial of OK-101 for Neuropathic Corneal Pain treatment at Tufts Medical Center.
Chief Scientific Officer Dr. Raj Patil will present 'Efficacy and Safety Results of First-in-Human Phase 2 Trial of OK-101 in Dry Eye Patients' during Poster Session III on November 2, 2024. The company aims to develop treatments for both neuropathic corneal pain, which currently lacks FDA-approved therapy, and inflammatory dry eye disease, representing a multi-billion-dollar market opportunity.
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