OKYO Pharma Ltd (NASDAQ:OKYO) CEO Gary Jacob talked with Proactive about the recently announced topline data from the company’s Phase 2 trial evaluating urcosimod in patients with neuropathic corneal pain.
Jacob explained that neuropathic corneal pain is a severe nerve pain condition without any FDA-approved treatments, describing it as “like having a spinal cord injury in your eye.”
The trial was a randomized, placebo-controlled study involving 48 patients. OKYO Pharma used confocal microscopy to ensure participants truly suffered from neuropathic pain rather than inflammatory causes.
The company decided to halt the study early after 17 patients completed 12 weeks of treatment due to significant reductions in pain observed in those receiving urcosimod topically.
Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is Gary Jacob. He is the CEO of OKYO Pharma. And Gary, it’s great to see you again. How are you?
Gary Jacob: Same here. A pleasure to speak with you.
Yeah. So you’ve got a really interesting news release out today, a very important one for the company. All dealt around Urcosimod, which is your current drug. And let’s start there. Remind everyone a little bit about this drug and sort of the path that got you to today.
Certainly. So of course we’re excited about this press release we put out today. It’s a very important one for the company. And just a reminder to your listeners, we’re going after—we’re really pioneering—the development of the first and only drug to treat a neuropathic corneal pain condition.
Now, neuropathic corneal pain—what is it? I tend to refer to it as having a spinal cord injury in your eye, because your cornea in your eye is the most heavily activated space for nerves. And if you get any damage to those nerves, you can get a type of pain that’s not like an inflammatory pain, like a dental pain or a headache. This is a nerve pain, like when you get a spinal cord injury and you get this burning, stinging sensations—only it’s worse in the cornea. And it’s so bad that there are incidents of people committing suicide. There is no FDA-approved drug to treat that condition called neuropathic corneal pain.
Yeah. So that’s what you’re hoping to do. And you were doing that in a number of ways. And that is—one of which was a clinical trial. And Gary, you stopped it a bit early because you wanted to sort of take a look at some of the data that came out of that. So tell me a bit about what you were able to accomplish so far as far as the trial is concerned and sort of the numbers that you’re looking at.
Certainly. So, the release itself is quite technical because we were reporting topline data on a Phase 2 trial. This trial is designed in what we call—it’s what’s called a randomized, placebo-controlled, double-masked trial. And why it’s designed that way is neither the patient nor the doctor know whether they’re getting drug.
And so we opened the trial back in October—a 48-patient trial in neuropathic pain. And incidentally, we use a technical confocal microscopy to ensure that these patients, actually have that kind of corneal nerve pain—not some kind of inflammatory pain.
So we announced that we are opening a 48-patient trial, randomized, placebo-controlled, in April of this year rather than waiting till hopefully by the end of the year. But the data out of 48 patients is based on the fact that even though it’s a trial that we don’t know whether patients are on drug or not, we do see the data on these patients and how they’re performing in reducing the kind of neuropathic pain.
And based on that, we felt it was more imperative that we stop with 17 patients completing the full 12 weeks—that’s 84 days of treatment—where they’re given the drug topically. And that’s an important point—topically in the eye. They take it four times a day. And we wanted to know: are the patients showing that we believe will be showing the major impact on their pain actually on drug or not?
So we stopped in April. We announced that we wanted to accelerate that trial. And today we announced the data and we were pleased at what we saw, because what we saw was a real significant reduction in pain in patients with the drug—who are on the drug.
Yeah. And that’s an important designation now because you were given the fast track designation for this. And so that allows you to get to the FDA to try and move things along much quicker. So with this type of data, Gary, will you go back now to the FDA and say, look, here’s what we have and sort of get set for the next stages?
That’s an excellent point. The fact that we, on May 1st, I believe, announced that we have fast track designation means that we are able to work very close to the FDA on an accelerated path to really look to develop this drug through to an approval.
So one of the reasons we stopped was we didn’t want to wait till the end of the year. We wanted to be able to see: is there a drug effect? Is this drug showing a real effect in reducing that pain? And if so, then we can go on a fast track now to really move forward with a discussion with FDA. Typically, it’s referred to as an end-of-Phase-2 meeting, but we also can be able to move our clinical program based on what we already know rather than waiting to the end of the year.
So that was also an important factor in why we announced that we wanted to see the data and why we’re so pleased at what we’re seeing and what we reported in that press release.
All right, well, we’ll be interested to see what happens with the FDA and everything that goes. But as you mentioned, Gary, this is a very significant news release for the company.
Absolutely. And we’re quite excited. And particularly because these are patients that have no approved drug, and they’re desperate to find something that helps them. And we are hoping that we can pioneer the development of a drug that will do just that.
Quotes have been lightly edited for clarity and style