OKYO Pharma Ltd (NASDAQ:OKYO) shares moved higher ahead of Friday’s opening bell after the biopharmaceutical firm announced that the US Food and Drug Administration (FDA) has cleared its first Investigational New Drug (IND) application for its drug candidate OK-101 for the treatment of neuropathic corneal pain.
The company can now progress with a Phase 2 study comparing OK-101 to placebo in neuropathic corneal pain patients which is scheduled to begin in the second quarter of 2024.
The trial will enrol 54 patients and the primary endpoint will be measured by VAS pain relief scores to enable a statistically valid demonstration of a true drug effect of OK-101 on neuropathic corneal pain symptoms.
It will be led by neuropathic corneal pain expert and OKYO Scientific Advisory Board member Dr. Pedram Hamrah of Tufts Medical Center as Principal Investigator.
“We are pleased to gain IND clearance for OK-101 to treat NCP as a second important disease target for the company,” OKYO CEO Dr. Gary S. Jacob said in a statement.
“OK-101 recently demonstrated favorable tolerability in a Phase 2 trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and blurred vision, which are also hallmarks of neuropathic corneal pain. OK-101 was also shown in a cutting-edge mouse model of NCP to significantly reduce ocular neuropathic pain.”
Investors welcomed the news, sending shares of OKYO almost 19% higher at $1.70 before Friday’s opening bell in New York.
OKYO Pharma is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of dry eye disease and neuropathic corneal pain, with ordinary shares listed for trading on the NASDAQ Capital Market.
Its lead asset OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response.