OKYO Pharma Ltd (NASDAQ:OKYO) CEO Gary Jacob joined Proactive to discuss recent developments in the company’s Phase 2 clinical trial for OK-101, an investigational therapy targeting neuropathic corneal pain (NCP).
Jacob highlighted a significant milestone for the trial: the first patient dosed. The CEO also noted that OK-101 has previously shown promising results in safety and efficacy during earlier trials for dry eye disease.
Proactive: You've got some news out about your Phase 2 trial for OK-101. Why don't we start there? Let's remind everyone a little bit about this particular drug and what it's designed to potentially do.
Gary Jacob: Well, we're very excited about our program on OK-101, which has already been through a major clinical trial in patient trials. We have a lot of safety data on this drug, and statistical significance as well. In a prior trial for dry eye disease patients, we saw a benefit in treating an ocular pain indication. What’s exciting is that this trial opens the possibility of treating neuropathic pain, a severe condition affecting the cornea. So this opening in the trial is a very important event for the company.
You've dosed the first patient, and that’s obviously a significant milestone. Maybe talk about that part and also what the trial is looking at specifically.
Sure. Just to begin, the neuropathic pain we’re addressing is not like chronic pain from a headache or toothache. This is severe, excruciating pain, more like what you’d experience with nerve damage in the spinal cord, but in the ocular nerves. It’s debilitating for patients, and there’s no FDA-approved drug to treat it. This trial is crucial because the FDA is keen to see a solution for these patients. We’ve enrolled 48 patients in a randomized, placebo-controlled, double-masked trial, which will run for 12 weeks. We expect a full readout of results by the summer of next year.
Absolutely. From what I understand, many people might not even realize they have this condition. And as you mentioned, it’s debilitating. So, is the need for treatment here as great as it seems?
Absolutely. These patients suffer and often rely on things like artificial tears or over-the-counter treatments, but there’s no FDA-approved drug to specifically address their condition. We are the first company to have an Investigational New Drug (IND) application approved by the FDA to study this patient group. This is a significant development for both the company and these patients.
Quotes have been lightly edited for clarity and style