LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a bio-pharmaceutical company specializing in ophthalmic treatments, has announced the initiation of a Phase 2 clinical trial for OK-101, its investigational drug for Neuropathic Corneal Pain (NCP). The trial marks the first of its kind to target NCP, a condition currently without FDA-approved treatments.
The study is a 12-week, double-masked, randomized, and placebo-controlled trial aimed at evaluating the safety and efficacy of OK-101 in patients diagnosed with NCP. A total of 48 patients are expected to participate, with the enrollment of the first patient already completed. NCP is a debilitating condition that arises from nerve damage to the cornea, often associated with dry eye disease, surgical procedures, or infections, and significantly affects the quality of life.
Dr. Pedram Hamrah, the Principal Investigator of the trial at Tufts Medical Center, emphasized the significant need for an approved therapy to address the persistent eye pain experienced by patients worldwide. His expertise in NCP and role as a co-inventor of OK-101 and member of OKYO's Scientific Advisory Board lends credibility to the trial's proceedings.
OK-101 is a non-opioid therapeutic candidate, designed to alleviate pain by targeting the ChemR23 receptor involved in the inflammatory response of the eye. The drug's development leverages a membrane-anchored-peptide technology to enhance its residence time in the ocular environment, aiming to provide a long-acting solution for NCP.
The company's CEO, Dr. Gary S. Jacob, expressed optimism about the potential of OK-101 to fulfill an unmet medical need in the treatment of NCP. He reiterated OKYO Pharma's commitment to advancing the drug's development to offer a new therapeutic option for patients.
OKYO Pharma, listed on the NASDAQ Capital Market, focuses on developing novel molecules to treat inflammatory Dry Eye Disease (DED) and ocular pain. The company has previously completed a Phase 2 trial of OK-101 for DED, showcasing its dedication to addressing ophthalmic conditions. Further information on the ongoing trial can be found on the clinical trials government website.
The company's forward-looking statements reflect their current expectations and projections about the potential of their clinical developments. However, they also acknowledge the risks and uncertainties inherent in drug development and the fact that these forward-looking statements are not guarantees of future performance.
This news article is based on a press release statement from OKYO Pharma Limited.
In other recent news, OKYO Pharma Ltd has initiated a Phase 2 clinical trial for its investigational drug, OK-101, aimed at treating Neuropathic Corneal Pain (NCP). The trial is designed as a double-masked, randomized, placebo-controlled study over 12 weeks, aiming to enroll 48 patients diagnosed with NCP. The primary measure for the trial's success is the relief of pain as assessed by the Visual Analog Scale (VAS).
OKYO Pharma has also secured a U.S. patent for OK-101, further strengthening its intellectual property portfolio. Executive Chairman, Gabriele Cerrone, has shown confidence in the company by increasing his stake through Panetta Partners Limited, now owning a total of 9,851,570 shares.
Analysts from H.C. Wainwright maintain a Buy rating for OKYO Pharma, indicating the potential of OK-101 to become the first FDA-approved therapy for NCP. OKYO Pharma's CEO, Dr. Gary S. Jacob, is also scheduled to appear on Bloomberg TV to offer insights into the company's business strategy and ongoing projects. These developments underscore OKYO Pharma's commitment to addressing unmet medical needs in ocular diseases.
InvestingPro Insights
As OKYO Pharma Limited (NASDAQ: OKYO) embarks on its Phase 2 clinical trial for OK-101, investors should be aware of some key financial metrics and insights provided by InvestingPro.
OKYO's market capitalization stands at $34.85 million, reflecting its current position as a small-cap biopharmaceutical company. This valuation aligns with the company's developmental stage and its focus on innovative ophthalmic treatments.
InvestingPro Tips highlight that OKYO is not profitable over the last twelve months, which is not uncommon for biotech companies in the research and development phase. The company's gross profit for the last twelve months as of Q4 2024 was -$7.51 million, indicating the substantial costs associated with drug development.
Notably, OKYO's stock price has fallen significantly over the last three months, with a -37.2% price total return. This decline may reflect market uncertainty about the company's clinical trial outcomes or general market conditions affecting small-cap biotech stocks.
For investors considering OKYO's potential, it's worth noting that InvestingPro lists 6 additional tips for this stock, providing a more comprehensive analysis for those seeking deeper insights.
As OKYO progresses with its clinical trials, these financial metrics and trends will be important to monitor alongside the company's scientific advancements. The success of the OK-101 trial could potentially impact OKYO's financial outlook and market perception in the coming months.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.