OKYO Pharma CEO discusses FDA Fast Track filing for urcosimod - ICYMI

OKYO Pharma Ltd (NASDAQ:OKYO) CEO Gary Jacob talked with Proactive about the company’s recent developments, including the formal naming of its drug candidate OK-101 as urcosimod.

Jacob discussed the company’s recent Fast Track application to the FDA, aimed at accelerating the regulatory pathway for urcosimod.

Proactive: Welcome back inside our Proactive newsroom. And joining me now is Gary Jacob. He is the CEO of OKYO Pharma Ltd. Gary, it's great to see you again. How are you?

Gary Jacob: I'm fine. It's so lovely to speak with you.

Yeah, lots of stuff to talk about. I know the company's been really busy over the last little while. You've had some news out on a number of different topics. So, first off, let's address the name — a name is in a name. OK-101 is what we've been talking about for quite some time, and now you've got your generic name that you're moving forward with. So that's a pretty significant one.

Yes it is. Thank you, Steve, for bringing that to the attention of the viewers, because I think most people don't realize when they go into a pharmacy — for example, here in the U.S. — the well-known non-steroidal anti-inflammatory Advil, people buy it, but it's a brand. The generic name is actually ibuprofen. So once a drug is off patent, generic companies can market it as ibuprofen.

So the generic name is what is basically associated with the drug itself. And we now have a generic name for what we used to call OK-101. That is Urcosimod — that's U-R-C-O-S-I-M-O-D. I love the name because it really focuses on its immune-modulating characteristic. So from here on in, you will no longer hear us use the term OK-101. We'll be talking about Urcosimod — the trial we first started in dry eye, and now of course we’re excited about this neuropathic cranial pain trial.

Yeah. And so on that, Gary, you've also filed for Fast Track with the FDA. Now, this is significant because this allows you to, I guess, go light speed to getting to where you want to get to. Explain to everyone why Fast Track is so important.

Absolutely. So what the FDA instituted was for drugs that deal with very serious conditions — where it's essential to move through as quickly as you can — they have what's called Fast Track designation for a drug. And we filed for that. We're very pleased. We'll be obviously looking to develop this drug rapidly.

The advantage of Fast Track, Steve, is that it accelerates the actual interaction with the FDA. You don't have to wait months for meetings — you can have them done more quickly. You can also do what's called a rolling filing of the NDA — the New Drug Application — and it also enables you to have a stronger conversation with the FDA to get their input on how you can move that drug rapidly through the regulatory process through to an approval.

Okay. And lastly, Gary, I want to ask you about a news release that you had out talking about shelf stability. A lot of people, I'm sure, when they go and look at the medication, go — "oh, there's a best-before date" on just about everything these days. Shelf stability is obviously a key thing, especially when you're developing something like you are.

Absolutely. A few words about that, that I don't think the viewers are generally aware of. When you're developing a drug through the FDA, you not only have to have the clinical data that shows the drug is efficacious and that it's safe — and of course, that is paramount to an approval — but there is also another section of an NDA filing, which is called the CMC section. That stands for Chemistry, Manufacturing, and Controls.

It's vital that the manufacturing is under good manufacturing processes. It's vital that you know the drug is going to remain stable and shelf-stable for a long period of time as well, because once it's out in a pharmacy, it can be there for many, many months. So it's vital you have that information demonstrated in a filing with the FDA.

This particular drug that we are developing is marketed in liquid form as eye drops. Our trials are done with little plastic ampoules that contain a very small amount of the drug, so patients can put it into their eye during the trial. It's a single-use ampoule. In fact, there are now drugs being marketed in single-use ampoules as well as plastic bottles.

What we reported just a couple of days ago was that we were very excited to demonstrate that our ampoules in long-term storage — dry for two and a half years — showed stability of over 95%, so virtually no degradation of the drug. This is very important because we now have data that go for two and a half years showing this drug is stable. This was done at refrigeration temperature. We also have stability studies being done at room temperature. Our expectation is that this drug will be given to patients in either ampoules or plastic bottles, and this stability data is very important for a successful FDA filing.

Quotes have been lightly edited for clarity and style