(Reuters) – 60 Degrees Pharmaceuticals said on Monday it has withdrawn an application to the U.S. Food and Drug Administration (FDA) for a mid-stage study testing its experimental drug in COVID-19 patients.
The decision follows FDA’s comments regarding the study design, the company said, adding that it plans to resubmit a revised application later in the year after a feasibility assessment.
The drug candidate, tafenoquine, was being developed to treat COVID-19 patients with mild-to-moderate symptoms and low risk of disease progression.
Tafenoquine, branded as Arakoda, was approved in the U.S. for prevention of malaria in 2018.
The company said it will decide whether to continue self-funding the study or seek a partner to continue development.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shounak Dasgupta)
