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60 Degrees Pharmaceuticals Registers ACLR8-LR, a Phase IIB Study of Tafenoquine for Treatment of COVID-19, on ClinicalTrials.gov
ACLR8-LR, a double-blind, randomized, placebo-controlled Phase IIB study to determine efficacy of the ARAKODA® regimen of tafenoquine in COVID-19 patients
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"ACLR8-LR, a double-blind, randomized, placebo-controlled Phase IIB study to determine efficacy of the ARAKODA® regimen of tafenoquine in COVID-19 patients with mild-moderate symptoms and low risk of disease progression, has been registered on ClinicalTrials.gov60P’s majority-owned subsidiary, 60P Australia Pty Ltd, has opened a new IND and will conduct the trial, enrolling patients at U.S. clinics beginning in fourth quarter of 2023Primary endpoint of ACLR8-LR will be time to sustained clinical recovery from COVID-19 symptoms60P was recently awarded a U.S. patent covering tafenoquine for treatment of COVID-19 and other lung infections. Tafenoquine is the active molecule in 60P’s FDA-approved drug for malaria prevention, ARAKODA60P estimates that 25 percent of U.S. population without risk factors for progression to serious COVID is not appropriate for currently marketed, oral treatments – a significant unmet need WASHINGTON, Aug. 15, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (“60 Degrees Pharmaceuticals” or “60P”) (NASDAQ: SXTP), a company specializing in developing and marketing medicines for infectious diseases, today announced that ACLR8-LR, a double-blind, randomized, placebo-controlled Phase IIB study to determine the efficacy of the ARAKODA® regimen of tafenoquine in COVID-19 patients with mild-moderate symptoms and low risk of disease progression, is now listed on ClinicalTrials.gov. The trial will be conducted by 60P’s majority-owned subsidiary, 60P Australia Pty Ltd, which opened a new IND on August 14, 2023. The primary endpoint of ACLR8-LR is time to sustained clinical recovery from COVID-19 symptoms. 60P plans to enroll patients in ACLR8-LR, recruited in up to 30 out-patient clinics across the U.S., beginning in the fourth quarter of 2023. 60P is also planning a second, larger COVID-19 study that is anticipated to commence in 2024. “Publicly registering ACLR8-LR represents an important milestone in 60P’s clinical research strategy,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow. “We remain optimistic that results of ACLR8–LR will play an important role in public health efforts to address gaps in the standard of care for COVID-19.” Public health interest in combating COVID-19 remains high. Currently marketed orally administered COVID-19 therapeutics are not appropriate for use...