OKYO Pharma Accelerates Urcosimod into Global Phase 3 Pivotal Trial for Neuropathic Corneal Pain Following FDA Alignment
核心洞察
OKYO Pharma received positive feedback from an FDA Type D meeting, validating the regulatory and clinical path forward for urcosimod in neuropathic corneal pain (搜索) (NCP).
The NEPTUNE Phase 3 pivotal trial will enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo across the United States and Europe.
Urcosimod is the first investigational therapy with an open IND specifically for NCP, a debilitating condition with no currently FDA-approved therapies.
OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company, announced positive feedback from its U.S. Food and Drug Administration (FDA) Type D meeting, validating the Company's regulatory and clinical path forward for urcosimod and supporting advancement into a global Phase 3 pivotal trial for neuropathic corneal pain (搜索) (NCP).
The FDA feedback provides increased clarity around the Company's updated regulatory strategy, reducing uncertainty and further supporting OKYO's plan to advance urcosimod through a potentially streamlined clinical development pathway. Based on discussions with the Agency, OKYO is positioning the planned NEPTUNE trial as a pivotal study that could support a potential single-trial registration strategy, subject to successful study results and continued FDA review.
"The outcome of our Type D meeting represents an important milestone and de-risking of our development program," said Flavio Mantelli, MD, PhD, Chief Medical Officer of OKYO Pharma. "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."
NEPTUNE Trial Design and Scope
The NEPTUNE (Neuropathic Eye Pain Treatment with Urcosimod & Nerve Evaluation) trial is a global study to be conducted in the United States and Europe. The study design is finalized to enroll approximately 111 subjects in a 2:1 randomization of 0.05% urcosimod versus placebo. The trial is positioned as a pivotal study that could support a potential single-trial registration strategy.
"Our strong balance sheet, together with regulatory clarity from the FDA supporting our accelerated clinical development plan, positions us to advance directly into our global Phase 3 urcosimod trial," said Robert J. Dempsey, Chief Executive Officer of OKYO Pharma. "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."
Urcosimod: First-in-Class Mechanism of Action
Urcosimod is a first-in-class, lipid-conjugated chemerin peptide agonist of the ChemR23 (搜索) G-protein-coupled receptor, which is typically found on immune cells of the eye responsible for the ocular inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. The investigational therapy has demonstrated ocular analgesic and anti-inflammatory pharmacologic activity through its dual mechanism of action, supporting its therapeutic potential to address the significant unmet medical need for patients with NCP.
Urcosimod is the first investigational therapy with an open Investigational New Drug (IND) application specifically for the treatment of neuropathic corneal pain (搜索) and has received Fast Track designation by the FDA.
Neuropathic Corneal Pain (搜索): A Debilitating Unmet Need
Neuropathic corneal pain (搜索) is a chronic, often severe, debilitating condition characterized by severe pain and sensitivity of the eyes, and in some cases the face or head. It is thought to result from damage or dysfunction of the corneal sensory nerves, often in combination with inflammatory processes, and may occur in association with a variety of underlying ocular conditions exhibiting pain that may be disproportionate to observable clinical findings. NCP is significantly under-researched, with no FDA-approved therapies, resulting in patients being treated with various topical and systemic medications in an off-label manner, often with limited or no success.
Regulatory Path Forward
Reflecting the significant unmet need in this debilitating disease, the company plans to seek FDA Breakthrough Therapy Designation (BTD), which may further accelerate the development and review pathway. OKYO plans to initiate the global Phase 3 pivotal clinical trial in the second half of this year.