OKYO Pharma Ltd (NASDAQ:OKYO) announced that it has received positive feedback from a US Food and Drug Administration Type D meeting that supports advancing its investigational therapy urcosimod into a global Phase 3 pivotal trial for neuropathic corneal pain (NCP).
The clinical-stage biotechnology company said the FDA aligned with its proposed single-dose Phase 3 study design and provided feedback that could support a potential single-trial registration pathway, subject to successful study results and continued agency review.
The planned Phase 3 study, named NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation), will be conducted in the US and Europe and is expected to enroll about 111 participants. The trial will randomize patients in a 2:1 ratio to receive either 0.05% urcosimod or placebo.
OKYO also said it plans to seek FDA Breakthrough Therapy Designation for urcosimod, which it believes could further accelerate the drug's development and regulatory review.
“The outcome of our Type D meeting represents an important milestone and de-risking of our development program,” OKYO chief medical officer Flavio Mantelli said in a statement.
“The FDA's feedback provided regulatory validation of our upcoming NEPTUNE clinical trial design, accelerating both the clinical development plan for urcosimod and our ability to generate meaningful data for patients, physicians, and regulators.”
OKYO CEO Robert J. Dempsey said the company believes its financial position and the FDA's feedback allow it to move directly into the global Phase 3 program.
“Most importantly, we remain committed to bringing a potential first in class, non-opioid treatment to patients living with this debilitating condition, for which there are currently no FDA-approved therapies,” Dempsey said.
Shares of OKYO moved 3.7% higher on Wednesday morning in New York.