OKYO Pharma Ltd (NASDAQ:OKYO) earlier this week reported positive feedback from its Type D meeting with the US Food and Drug Administration (FDA), providing greater regulatory clarity as the company advances urcosimod toward a global Phase 3 pivotal study for neuropathic corneal pain (NCP).
Chief executive Robert Dempsey said the FDA's feedback supports a streamlined development strategy that could allow the company to conduct a single-dose Phase 3 study with the potential to serve as a single pivotal trial.
Dempsey said the regulatory alignment "accelerates urcosimod into a global Phase 3 pivotal trial for neuropathic corneal pain" and strengthens the company's overall clinical development programme.
The planned Neptune Phase 3 trial is expected to enrol approximately 111 patients using a 2:1 randomisation of 0.05% urcosimod versus placebo. The company is close to finalising approximately 14 clinical sites across the United States and Europe, with management aiming to begin enrolment as quickly as possible.
A further catalyst highlighted during the interview is the company's intention to seek Breakthrough Therapy designation from the FDA. If granted, the designation could help accelerate the development and regulatory review process.
Proactive: Welcome back inside our Proactive newsroom. Joining me now is Robert Dempsey, CEO of OKYO Pharma. Bob, it's good to see you again. How are you?
Robert Dempsey: I'm doing well. Thank you very much. It's always a pleasure to speak with you and provide an update on the status of OKYO Pharma.
Last time we spoke, you mentioned you were preparing for a Type D meeting with the FDA to help determine the next stage of development. You've now received positive feedback from that meeting.
Yes. Our strategy was to enhance our development plan. We are reporting positive feedback from our Type D meeting, which we believe accelerates urcosimod into a global Phase 3 pivotal trial for neuropathic corneal pain. We believe this alignment allows us to advance the program with a single-dose Phase 3 study. The design developed by our Chief Medical Officer has the potential to support a single pivotal trial, strengthening our clinical development program.
This will be the Neptune Phase 3 trial and represents one of the final development steps before potentially bringing the treatment to patients.
Helping patients is the most important point. Through further research into neuropathic corneal pain, we've seen the significant burden these patients experience. The study is expected to enrol approximately 111 participants using a 2:1 randomisation of 0.05% urcosimod versus placebo. We also plan to seek Breakthrough Therapy designation, which may further accelerate development. Since our Chief Medical Officer and I joined the company, we've focused on advancing the program as quickly as possible to address this significant unmet medical need.
There are currently no approved treatments for neuropathic corneal pain, so the FDA recognises the importance of advancing potential therapies.
That's exactly our approach. Following our Type C meeting in January and the recent Type D meeting, our relationship with the FDA has helped move the program forward. We're close to finalising approximately 14 trial sites across the United States and Europe. Once activated, we believe these sites will enable enrolment of approximately 111 participants as we move the trial ahead as quickly as possible.
The company is also in a strong financial position to support the study.
Yes. Our strong balance sheet, together with the regulatory clarity from the FDA, gives us a clear path to execute the trial. We have sufficient cash to complete the study while maintaining a financial buffer should we need additional capital or pursue other opportunities.
Great to catch up with you. I look forward to speaking again as the program progresses.
Thank you. I appreciate the opportunity to provide this update.
Quotes have been lightly edited for clarity and style