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On Friday, H.C. Wainwright maintained a positive outlook on shares of OKYO Pharma Ltd. (NASDAQ: OKYO), reiterating a Buy rating and a $7.00 price target. The firm's stance comes in the wake of the company's announcement to progress its drug candidate OK-101 into a Phase 2 trial for treating neuropathic corneal pain (NCP), a condition that currently lacks an FDA-approved therapy.
NCP is characterized by eye pain and sensitivity, potentially stemming from nerve damage in the cornea along with inflammation. Patients with NCP are generally treated with various off-label topical and systemic medications. OKYO Pharma's OK-101 has shown promise in a mouse model, demonstrating a reduction in corneal pain that was comparable to gabapentin, a medication often used for nerve pain, by the 14th day after surgery.
Further supporting OK-101's potential, Phase 2 Dry Eye Disease (DED) trial results indicated significant improvements in patient-reported pain scores within the first two weeks, extending through the 85th day of the study. These findings have paved the way for the evaluation of OK-101 in treating NCP, an orphan disease recognized by the National Organization for Rare Disorders.
OK-101 stands out as the first NCP drug candidate to receive FDA Investigational New Drug (IND) clearance for clinical trials. OKYO Pharma's management anticipates the commencement of the Phase 2 trial in the third quarter of 2024, with expectations of reporting topline results by mid-2025.
The prospect of OK-101 becoming the first FDA-approved therapy for NCP was highlighted, suggesting that positive trial outcomes could significantly enhance the drug's market position, especially considering its application in DED. The reaffirmed $7.00 price target reflects the firm's confidence in the drug's potential and OKYO Pharma's future prospects.
In other recent news, OKYO Pharma has made significant strides in advancing its drug candidate, OK-101, into a Phase 2 clinical trial to treat neuropathic corneal pain (NCP). The decision follows promising results from an earlier Phase 2 study in dry eye disease (DED) patients and supportive preclinical data. The trial aims to evaluate the efficacy and safety of OK-101, a lipid conjugated chemerin peptide agonist, in a larger cohort of patients suffering from NCP, a condition with limited treatment options.
Furthermore, OKYO Pharma has identified conjunctival staining and ocular pain as potential primary endpoints for future trials. This strategic focus was guided by comprehensive review of the Phase 2 trial data, aiming to enhance the effectiveness and precision of future studies on OK-101.
The company's CEO, Dr. Gary S. Jacob, and CFO, Keeren Shah, have expressed commitment to addressing unmet medical needs in ophthalmology, and optimism about the drug's potential. These recent developments represent a significant step in OKYO Pharma's efforts to bring new solutions to patients with challenging medical conditions.
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