(Reuters) – Spain’s Pharma Mar said on Wednesday that it has obtained regulatory approval in Britain for a late-stage clinical trial of its Aplidin drug to treat patients who have been hospitalised with a moderate COVID-19 infection.
Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the first regulator to authorise the Neptuno trial, which aims to compare the efficacy of Aplidin against standard treatments for moderate cases of the disease.
Pharma Mar said it hopes to enrol some 600 patients across 12 countries for the Phase III trial.
Pharma Mar shares were trading 0.78% higher at 1102 GMT recovering from a 6.7% slump before the announcement.
(Reporting by Michael Susin; editing by Nathan Allen and Jason Neely)