OKYO PHARMA LTD Stock Price, News & Analysis

OKYO Pharma announces plans to accelerate the development of urcosimod for treating Neuropathic Corneal Pain (NCP). The company is closing its Phase 2 trial early after 17 patients completed the study at Tufts Medical Center in Boston.

The trial, initiated in October 2024, was designed as a double-masked, randomized, 12-week placebo-controlled study. The decision to end early stems from OKYO's desire to analyze the current data and expand to a multicenter trial. Several patients who completed the trial have requested continued compassionate use of urcosimod.

The company expects data analysis to take approximately 6 weeks and plans to meet with the FDA to discuss accelerated development plans. Urcosimod has already shown favorable safety and placebo-like tolerability in a previous 240-patient Phase 2 trial. NCP currently has no FDA-approved therapy, making this development significant for patients who have had limited success with other treatments.

OKYO Pharma (NASDAQ: OKYO) has announced significant stability data for its drug candidate urcosimod, currently in Phase 2b clinical trials for Neuropathic Corneal Pain (NCP). The drug has demonstrated remarkable stability in single-use ampoules over a 2½-year period under refrigerated conditions, with stability rates of 94.8% for 0.05% concentration and 97.4% for 0.1% concentration.

The stability testing is a important requirement for FDA approval, addressing shelf-life concerns for the drug. Additionally, room temperature stability testing has shown promising early results, with 3-month stability rates at or above 100%. The company notes that single-use ampoules are increasingly preferred for ophthalmic drugs over plastic bottles, offering better sterility control for long-term daily administration.

Urcosimod is being evaluated in a randomized, placebo-controlled, double-masked trial involving 48 patients for NCP, a severe ocular condition currently lacking FDA-approved treatments. The drug has also shown potential in treating inflammatory dry eye disease (DED), a multi-billion-dollar market opportunity.

OKYO Pharma (NASDAQ: OKYO) has filed an application for Fast Track designation with the FDA for its drug urcosimod (formerly OK-101) to treat neuropathic corneal pain. This condition, affecting tens of thousands globally, is characterized by chronic, severe eye discomfort with no current FDA-approved treatment.

The company is developing urcosimod for both neuropathic corneal pain and inflammatory dry eye disease, the latter representing a multi-billion-dollar market opportunity. Fast Track designation is designed to expedite the development and review process for drugs treating serious conditions that lack FDA-approved treatments.

OKYO Pharma (NASDAQ: OKYO) announced that its lead drug candidate OK-101 has been officially assigned the United States Adopted Name (USAN) 'urcosimod'. The drug is currently in Phase 2 clinical trials for neuropathic corneal pain (NCP), a condition without FDA-approved treatments, and has shown promising results in Phase 2 trials for inflammatory dry eye disease (DED).

Urcosimod is a lipid-conjugated small molecule designed to target ocular G-protein coupled receptors (GPCRs), combining anti-inflammatory and pain-modulating properties. The ongoing Phase 2 trial for NCP, initiated in October 2024, is expected to release top-line results in Q4 2025. The suffix '-mod' in the name reflects its role as a modulator of inflammatory and neuropathic pathways.

OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on neuropathic corneal pain (NCP) and inflammatory dry eye disease (DED) treatments, has announced significant insider share purchases. CEO Gary S. Jacob acquired 10,000 ordinary shares at US$1.04 per share on NASDAQ. Additionally, Panetta Partners , connected to Executive Chairman Gabriele Cerrone, purchased 20,000 ordinary shares at the same price. Following these transactions, Cerrone's total shareholding has reached 9,871,570 shares, representing 28.96% of the company's issued share capital.

Goldman Small Cap Research has published a new research report on OKYO Pharma (NASDAQ:OKYO), highlighting its potential in the ophthalmic drugs segment. OKYO's lead drug candidate OK-101 has completed a 240-patient Phase 2 trial in Dry Eye Disease (DED) and is currently being evaluated in a 48-patient Phase 2 trial for Neuropathic Corneal Pain (NCP).

The company is notable for being the first to receive FDA approval for NCP clinical trials and launch a specific NCP patient trial. Goldman estimates the potential NCP market size at $6.4 billion, based on 160,000 US potential patients, contingent on receiving Orphan Drug designation. The report suggests OKYO could attract potential joint venture partners or acquirers in 2026/2027, with several milestones expected in 2025.

OKYO Pharma provided updates on its clinical trials and financial results for the six months ended September 30, 2024. The company expects to complete enrollment of 48 patients in its Phase 2a trial of OK-101 for Neuropathic Corneal Pain (NCP) by Q2 2025, with top-line data expected in Q4 2025.

Earlier in January 2024, OKYO reported positive top-line data from its Phase 2b trial of OK-101 for Dry Eye Disease (DED). The drug showed statistically significant benefits in total conjunctival staining by Day 29 and improved symptoms like burning/stinging and blurred vision. The safety profile was favorable, with TEAEs similar to placebo.

Financially, OKYO reported total assets of $2.8 million as of September 2024, including $1.0 million in cash, with an additional $1.8 million received post-period. The company's comprehensive loss decreased to $3.1 million compared to $8.5 million in the same period last year.

OKYO Pharma (NASDAQ: OKYO) has secured $1.4 million in non-dilutive funding to advance its innovative pipeline, particularly focusing on its lead program OK-101 for treating neuropathic corneal pain (NCP). The company, which develops therapies for NCP - a severe ocular condition without FDA-approved treatments - and inflammatory dry eye disease (DED), will use this funding to support ongoing research and development initiatives.

The funding strengthens OKYO's ability to progress its development programs without diluting shareholder value. CEO Dr. Gary S. Jacob emphasized that this financial boost will contribute significantly to their mission of developing groundbreaking treatments for ophthalmic diseases while maintaining fiscal responsibility and creating value for shareholders.

OKYO Pharma (NASDAQ: OKYO), a clinical-stage biopharmaceutical company focused on treating neuropathic corneal pain and inflammatory dry eye disease, announces its participation in the 4th Annual Virtual BTIG Ophthalmology Day on December 2nd, 2024. CEO Gary S. Jacob will engage in one-on-one meetings and lead a fireside chat from 2:40-3:15pm.

The event will feature over 20 medical technology and biotechnology companies, discussing latest developments in ophthalmic technologies and therapeutics. OKYO is developing treatments for NCP, which currently lacks FDA-approved therapies, and DED, representing a multi-billion-dollar market opportunity.