OKYO Pharma Ltd, a biotechnology company specializing in biological products, has announced its plan to progress its drug candidate OK-101 into a Phase 2 clinical trial for the treatment of neuropathic corneal pain. The trial is set to commence in the third quarter of 2024.
The decision to move forward with the Phase 2 trial comes after encouraging outcomes from pre-clinical animal model studies and a recent human trial in Dry Eye Disease (DED) patients that showed statistically significant pain relief. The one-year study aims to further evaluate the efficacy and safety of OK-101 in a larger cohort of patients suffering from neuropathic corneal pain, a condition that currently has limited treatment options.
The London-based firm, listed on the Securities Exchange Act of 1934 under the file number 001-41386, made the announcement on Thursday, July 11, 2024. OKYO Pharma's Chief Financial Officer, Keeren Shah, signed off on the report, indicating the company's commitment to addressing unmet medical needs in ophthalmology.
OKYO Pharma Ltd is focused on the discovery and development of novel therapies. Its latest move to advance OK-101 into Phase 2 trials represents a significant step in the company's efforts to bring new solutions to patients with challenging medical conditions.
In other recent news, OKYO Pharma Ltd has reported significant findings from its Phase 2 clinical trial of OK-101, a potential treatment for Dry Eye Disease (DED). The trial data highlighted conjunctival staining and ocular pain as potential primary endpoints for future trials, with a 68% improvement in the responder rate among patients exhibiting reductions in these symptoms. These findings aim to enhance the precision and effectiveness of subsequent studies on OK-101.
OKYO Pharma's decision to focus on these endpoints, following a comprehensive review of the trial data, is expected to streamline the drug's development pathway and potentially provide relief for DED patients. The company's Chief Financial Officer, Keeren Shah, approved the report, which was submitted as part of a Form 6-K.
CEO of OKYO Pharma, Gary S. Jacob, Ph.D., highlighted the importance of these findings for patients with DED, particularly those with a pain component. The company plans to discuss the next steps for OK-101 with advisors and regulatory agencies. In addition, OKYO Pharma is preparing for a Phase 2 trial of OK-101 to address neuropathic corneal pain (NCP), a condition currently without an FDA-approved therapy.
InvestingPro Insights
As OKYO Pharma Ltd gears up for the Phase 2 clinical trial of its promising drug candidate OK-101, investors are keeping a close eye on the company's financial health and market performance. According to real-time data from InvestingPro, OKYO Pharma's market capitalization stands at $38.89 million, reflecting its position in the biotechnology market. Despite the potential of OK-101, the company's stock has experienced a downturn over the last month, with a 17.2% drop in price total return, which aligns with an overall negative six-month performance showing a 30.77% decline.
InvestingPro Tips highlight that OKYO Pharma suffers from weak gross profit margins and a valuation that implies a poor free cash flow yield, which could be of concern to investors looking for robust financials. Additionally, the company does not pay a dividend, which may influence investment decisions for those seeking income-generating stocks. For investors considering a deeper dive into OKYO Pharma's prospects, there are additional InvestingPro Tips available that could provide a more comprehensive understanding of the company's financial nuances.
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