OKYO Pharma Ltd (NASDAQ:OKYO) said on Monday that its experimental drug urcosimod has demonstrated stability for over two and a half years in single-use ampoules.
The biopharmaceutical company’s confirmation that urcosimod remains stable for over two and a half years in single-use ampoules – small, sealed containers designed to hold a single dose of liquid medication – is an important step in bringing the company closer to submitting a successful New Drug Application (NDA) for FDA approval.
“One of the major requirements for drug approval is that the drug is stable to degradation for a considerable period of time,” CEO Gary Jacob explained.
“This addresses the issue of shelf stability for a drug, and the fact that we have now established this for urcosimod is a critical positive step in meeting CMC requirements for a successful New Drug Application (NDA) with FDA.”
OKYO Pharma’s Chief Scientific Officer Raj Patil added that stability testing under refrigerated conditions showed "impressive" retention rates, with 0.05% urcosimod maintaining 94.8% stability and 0.1% urcosimod at 97.4% over the period. Early results from room-temperature storage have also been promising, the company said.
Urcosimod, formerly known as OK-101, is designed to target inflammation and pain through its action on the ChemR23 receptor. The drug is administered as eye drops and aims to provide a long-acting treatment for patients with NCP, a chronic and debilitating condition for which no FDA-approved therapy currently exists.
Urcosimod is currently being evaluated in a Phase 2b randomized, placebo-controlled clinical trial involving 48 patients with NCP.
The trial is being conducted at Tufts Medical Center under the leadership of Dr Pedram Hamrah.