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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 Limited (NASDAQ: OKYO; LSE: OKYO) announced that Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone, purchased 12,500 American Depositary Shares (ADSs) on NASDAQ for $1.32 each on March 27, 2023. This transaction reflects a significant investment in the company focused on developing OK-101, a treatment for dry eye disease aimed at addressing unmet needs in a multi-billion-dollar market. The purchase indicates the confidence of the Chairman in the company's potential, as it expands its focus on ophthalmology and chronic pain treatments.
OKYO Pharma Limited (Nasdaq: OKYO; LSE: OKYO) announced a purchase of 10,000 American Depositary Shares (ADSs) at $1.40 each by Panetta Partners Limited, associated with Executive Chairman Gabriele Cerrone. This transaction, valued at $14,000, is significant in the context of OKYO's development of OK-101, a treatment for dry eye disease in a burgeoning market. The purchase reflects confidence in OKYO’s strategy amidst the pressing need for innovative solutions in ophthalmology. The transaction took place on March 23, 2023, on the NASDAQ.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company, announced the posting of its planned clinical trial for OK-101 to treat dry eye disease (DED) on ClinicalTrials.gov (Identifier: NCT05759208). The company is activating clinical sites and preparing the trial drug for shipment, anticipating the first-patient visit in early Q2 2023, with top-line data expected in Q4 2023. CEO Gary S. Jacob expressed optimism about OK-101 providing a new treatment option for DED patients who lack effective therapies.
OKYO Pharma Limited (Nasdaq: OKYO; LSE: OKYO) has announced a global private placement to raise approximately $5.4 million through the issuance of new American Depositary Shares (ADSs) and ordinary shares. The company will issue 3,503,665 new ADSs at $1.50 each, representing 227,738,225 ordinary shares, and 8,673,658 ordinary shares at $0.23 each. Proceeds will be utilized for advancing the Phase 2 clinical trial of OK-101 for dry eye disease (DED) and other corporate purposes. The closing of the U.S. Offering is expected on March 14, 2023, with shares expected to be listed on the London Stock Exchange shortly thereafter.
On March 13, 2023, OKYO Pharma announced a public offering of 3,503,665 American Depositary Shares (ADSs) at $1.50 each, aiming to raise approximately $5.3 million. The offering is set to close on March 15, 2023. The funds will primarily support the Phase 2 clinical trial of OK-101 for inflammatory dry eye diseases and will also cover general corporate expenses. Additionally, the company completed a concurrent offering in the UK, securing $0.3 million from the sale of 13,836,156 ordinary shares to management and directors. The registration statement for the ADSs was filed with the SEC and became effective on March 8, 2023.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that its GMP packaged drug OK-101 for treating dry eye disease (DED) has cleared customs in the U.S. The company is preparing for its first-in-human Phase 2 clinical trial, with randomization codes being generated and clinical sites being authorized. Anticipated timelines include the first patient visit in Q1 2023 and top-line data release in Q4 2023. OK-101 aims to address significant unmet needs in the multi-billion-dollar DED market, leveraging its unique design to enhance drug retention in the ocular environment.
OKYO Pharma has appointed Dr. Jay S. Pepose, a leading ophthalmologist, to its Scientific Advisory Board to guide clinical programs for OK-101, a treatment for dry eye disease. Dr. Pepose brings nearly 40 years of experience and a robust background in clinical trials for ophthalmic conditions. The company plans to initiate enrollment for its Phase 2 clinical trial for OK-101 within Q1 2023. This strategic appointment aims to enhance the profile of OK-101 amidst a multi-billion-dollar market with significant unmet needs. Dr. Pepose's insights on ocular inflammation and pain management are expected to drive the development of this promising therapy.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that CEO Gary S. Jacob, Ph.D., will present on the therapeutic potential of OK-101 for dry eye disease at the GPCRs-Targeted Drug Discovery Summit on February 22, 2023, in Boston. His presentation follows that of Dr. Alan Kopin, who will share insights on the discovery and testing of OK-101. Recently, OKYO received FDA clearance for its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for OK-101, aiming to address the significant unmet need in treating dry eye disease.
OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO) has announced its interim results for the six months ending September 30, 2022. The company has achieved FDA IND clearance for its Phase 2 trial of OK-101 to treat Dry Eye Disease (DED), expected to begin in Q1 2023. Financially, OKYO reported total assets of £1.6 million and cash of £0.6 million, with a comprehensive loss of £4.6 million. The company has halted further development of OK-201 to focus resources on OK-101.
OKYO Pharma Limited has received FDA clearance to start a Phase 2 clinical trial for OK-101, a treatment for Dry Eye Disease (DED). This first-in-human study will assess both efficacy endpoints relating to the signs and symptoms of DED. The trial is set to begin in Q1 2023, aiming to demonstrate OK-101's potential as a novel treatment option for patients inadequately addressed by existing medications. The company emphasizes that success in this trial could expedite the filing for a new drug application (NDA) with the FDA.
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