LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical company specializing in ocular therapies, has commenced the screening and recruitment process for a Phase 2 clinical trial of its drug candidate OK-101, aimed at treating neuropathic corneal pain (NCP). The trial is a double-masked, randomized, and placebo-controlled study slated to include 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).
NCP is an orphan disease causing pain and sensitivity in the eyes, face, or head, and is currently managed off-label with various treatments. OK-101, which has shown promise in reducing symptoms of dry eye disease in a previous Phase 2 trial, is now being evaluated for its effectiveness in addressing NCP, for which there are no FDA-approved treatments.
The trial is spearheaded by Dr. Pedram Hamrah, a renowned expert in NCP and the Principal Investigator, at Tufts Medical Center. Dr. Hamrah, who is also a co-inventor on the OK-101 patent, emphasized the importance of rigorously testing OK-101 in this patient population.
OK-101's development leverages membrane-anchored-peptide technology, which aims to produce a long-acting drug candidate by enhancing the residence time of the molecule within the ocular environment. It is a chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune cells in the eye.
Gary S. Jacob, Ph.D., CEO of OKYO Pharma, highlighted the significance of the trial following the company's focus on advancing OK-101 into clinical testing for NCP. He also pointed out the drug's potential anti-inflammatory and pain-reducing effects observed in pre-clinical animal studies.
This announcement is based on a press release statement and contains forward-looking statements about the company's expectations for OK-101's clinical development. These statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those projected.
In other recent news, OKYO Pharma has embarked on a Phase 2 clinical trial for its investigational drug OK-101, targeting neuropathic corneal pain (NCP). This development is a significant step forward in the company's ongoing efforts to address unmet medical needs in ocular diseases. OKYO Pharma has also secured a crucial U.S. patent for OK-101, reinforcing its intellectual property portfolio.
Executive Chairman, Gabriele Cerrone, has demonstrated his confidence in the company's future by increasing his stake through Panetta Partners Limited, now owning a total of 9,851,570 shares. This move coincides with the company's preparation for another Phase 2 trial of OK-101.
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 set to appear on Bloomberg TV, offering insights into the company's business strategy and ongoing projects. These are all recent developments underscoring OKYO Pharma's commitment to growth and therapeutic advancements in the biopharmaceutical sector.
InvestingPro Insights
As OKYO Pharma Limited (NASDAQ: OKYO) advances its clinical trials for OK-101, investors should consider the company's financial position and market performance. According to InvestingPro data, OKYO has a market capitalization of $34.51 million, reflecting its current valuation as a clinical-stage biopharmaceutical company.
The company's financial metrics reveal some challenges. An InvestingPro Tip indicates that OKYO is not profitable over the last twelve months, which is not uncommon for early-stage biotech firms investing heavily in research and development. This is further evidenced by the company's operating income of -$15.75 million for the last twelve months as of Q4 2023.
Another InvestingPro Tip highlights that OKYO's short-term obligations exceed its liquid assets, which could potentially impact the company's ability to fund ongoing clinical trials without additional financing. This financial position underscores the importance of the Phase 2 trial's success for OK-101, as positive results could potentially attract investor interest or partnership opportunities.
Despite these challenges, analysts seem optimistic about OKYO's potential. The fair value based on analyst targets is $7 per share, significantly higher than the previous closing price of $1.02. This disparity suggests that if OK-101 demonstrates efficacy in treating neuropathic corneal pain, there could be substantial upside potential for the stock.
Investors considering OKYO should be aware that InvestingPro offers 5 additional tips for this stock, providing a more comprehensive analysis of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.