LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical company, announced plans to initiate a Phase 2 clinical trial for its drug candidate, OK-101, to treat neuropathic corneal pain (NCP) in the third quarter of 2024. The trial follows promising results from an earlier Phase 2 study in dry eye disease (DED) patients and supportive preclinical data.
NCP, recognized as an orphan disease by the National Organization for Rare Disorders, currently lacks an FDA-approved treatment. OK-101, a lipid conjugated chemerin peptide agonist targeting the ChemR23 receptor, has demonstrated significant pain relief in DED patients and reduced NCP in a mouse model.
The upcoming double-masked, randomized, placebo-controlled trial will involve 48 patients diagnosed with NCP via confocal microscopy. The primary endpoint will be pain improvement measured by the visual analog scale (VAS) over 12 weeks, with a follow-up four weeks post-trial.
Dr. Pedram Hamrah, a renowned expert in NCP and co-inventor of the OK-101 patent, will lead the study at Tufts Medical Center. "I am looking forward to rigorously evaluating OK-101’s potential in treating pain symptoms in patients suffering from neuropathic corneal pain," stated Dr. Hamrah.
OKYO's CEO, Dr. Gary S. Jacob, expressed optimism about the drug's potential, highlighting its novel mechanism of action and the unmet medical need in the ophthalmic field. OK-101 aims to provide a long-acting treatment option with its unique lipid anchor, designed to enhance its residence time in the ocular environment.
The company's announcement is based on a press release statement.
In other recent news, OKYO Pharma Ltd has made significant strides in its drug development efforts. The company has unveiled encouraging results from its Phase 2 clinical trial of OK-101, a potential treatment for Dry Eye Disease (DED). The trial demonstrated a 68% improvement in responder rate among patients who showed a reduction in both conjunctival staining and ocular pain, which are being considered as co-primary endpoints for future trials.
These recent developments are part of OKYO Pharma's ongoing commitment to addressing unmet medical needs in ophthalmology.
InvestingPro Insights
As OKYO Pharma Limited (NASDAQ: OKYO) gears up for the Phase 2 clinical trial of its drug candidate OK-101, the company's financial health and market performance provide a broader context for investors. According to InvestingPro data, OKYO has a market capitalization of 38.89 million USD, underscoring its status as a smaller player in the biopharmaceutical space. Notably, the company's stock has experienced significant volatility, with a one-month price total return of -17.2% and a year-to-date (YTD) price total return of -33.9%, reflecting the challenges faced in the market.
InvestingPro Tips highlight some of the headwinds OKYO faces, such as weak gross profit margins and a stock performance that has fared poorly over the last month. Additionally, the company's valuation implies a poor free cash flow yield, which could be a concern for investors looking for long-term profitability. Furthermore, OKYO does not pay a dividend, which may influence the investment decisions of those seeking regular income from their holdings.
For investors considering OKYO Pharma as a potential addition to their portfolio, it is crucial to assess these financial metrics in conjunction with the company's promising clinical developments. With a fair value (analyst targets) of 7 USD, there may be a significant upside potential if the company's trials prove successful and the drug reaches the market.
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