60 Degrees Pharma withdraws mid-stage study application for COVID drug

60 Degrees Pharmaceuticals

18/09/2023 22:15

Sept 18 (Reuters) - 60 Degrees Pharmaceuticals  SXTP.O 
said on Monday it has withdrawn an application to the U.S. Food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)
 ((Mariam.ESunny@thomsonreuters.com))