Okyo Pharma has announced plans to commence a Phase II clinical trial of investigational therapeutic OK-101 for patients with neuropathic corneal pain (NCP).
The company announced the trial initiation plans following the signing of an agreement with Tufts Medical Center in the US.
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The open-label trial intends to enrol 40 NCP patients to assess the safety and efficacy of OK-101 for usage as a non-opioid analgesic.
Expected to last six to nine months, the trial is anticipated to cost less than $1m, including expenses for the production and formulation of the drug for investigational purposes.
The company intends to submit an investigational new drug (IND) application for OK-101 in NCP indication to the US Food and Drug Administration (FDA) in the fourth quarter of 2023.
Subject enrolment in the trial will be initiated following IND approval.
In mouse models of NCP and dry eye disease, OK-101 is said to have produced anti-inflammatory and pain-reduction properties.
OK-101 is presently in a multicentre, double-masked, placebo-controlled Phase II trial as a topical ocular therapeutic for dry eye disease treatment.
Okyo Pharma CEO Dr Gary Jacob said: “We are excited about OK-101’s dual combination of anti-inflammatory ocular activity and NCP-reducing activity, and are eagerly awaiting the top-line data from the dry eye disease trial.
“But, we are also eager to move forward with our plan to evaluate this drug to treat NCP, which has gained considerable significance this past year as a major unmet medical need for patients specifically diagnosed with this debilitating ocular condition.”
