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Okyo Pharma Ltd’s half-year loss widened dramatically, while it also said on Friday it expects to initiate phase 2 of a clinical trial of its dry eye disease treatment OK-101 in early 2023.
The London-based ophthalmology-focused bio-pharmaceutical company said total loss and comprehensive loss in the six months that ended September 30 was £4.6 million, multiplying from £1.8 million a year earlier.
Cash on hand on September 30 was £600,000, down 71% from £2.1 million on March 31, while total assets fell by 52% to £1.6 million from £3.3 million.
Okyo Pharma said its primary focus during the half-year period was towards filing an investigational new drug application with the US Food & Drug Administration for OK-101 to treat dry eye disease.
It said it completed the topical formulation of the drug product with initial stability studies, finalised the bioanalytical method development to support OK-101’s clinical programme, and completed a batch manufacture for clinical trials. This was alongside developing its toxicokinetic method and conducting toxicology studies in rabbits and dogs.
Last week, Okyo Pharma received IND clearance from the FDA for its planned phase 2 trial, which it expects to initiate in the first quarter of 2023.
Okyo Pharma said it halted all further work on its OK-201 formulation, as it focused its ‘full energies’ on obtaining IND clearance for OK-101. This follows its decision to pause further development of OK-201 at the end of 2021, despite encouraging test results earlier in the year.
Okyo Pharma expects the phase 2 trial of OK-101 to be completed in six to nine months from enrolment of the first patient. It said the study was designed in conjunction with Ora Inc, which also will manage and monitor the upcoming trial.
Shares in Okyo Pharma were down 8.0% to 2.53 pence each in London on Friday morning.
By Greg Rosenvinge, Alliance News reporter
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