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60 Degrees Pharmaceuticals Suspends Phase IIB Study of Tafenoquine for COVID-19, Pivots to Refocus on Commercialization of Treatments for Malaria and Tick-Borne Diseases
FDA advice to Company suggested execution of ACLR8-LR, a placebo-controlled Phase IIB study of tafenoquine in COVID-19 patients, may not be feasible in the
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"FDA advice to Company suggested execution of ACLR8-LR, a placebo-controlled Phase IIB study of tafenoquine in COVID-19 patients, may not be feasible in the U.S. Company will therefore focus efforts on further commercialization related to ARAKODA® (tafenoquine) for prophylaxis of malaria, and prepare for a Phase IIA study of tafenoquine in hospitalized babesiosis patients Company is preparing for submission of a pre-IND meeting request with FDA for babesiosis in the current fourth quarter of 2023, and plans to appoint a chief commercial officer to lead ARAKODA commercialization WASHINGTON, Oct. 12, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that its subsidiary, 60P Australia Pty Ltd, will not re-submit its investigational new drug application (“IND”) for ACLR8-LR, a Phase IIB study of tafenoquine compared to placebo in patients with mild to moderate COVID-19 disease and low risk of disease progression. Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention. The Company’s Board of Directors decided on October 6, 2023, that recent advice from the FDA made moving forward with the ACLR8-LR clinical development plan unfeasible. The FDA has approved or authorized two marketed oral products, Lagrevio™ and Paxlovid™, for use in cases of mild-to-moderate COVID-19 disease to reduce the rate of hospitalizations and deaths in patients with high risk of disease progression. However, the FDA has explicitly not authorized the use of those products in patients with low risk of COVID-19 disease progression. Accordingly, Lagrevio and Paxlovid are not recommended by public health agencies for that purpose. Current literature on COVID-19 shows that low risk patients have a very low risk of hospitalization. However, patients may wish to make a risk-based decision together with their physician to use a therapeutic that accelerates clinical recovery from COVID-19 symptoms if such a therapeutic were available. FDA guidance for industry implies that a regulatory pathway does exist for approval of new therapeutics that produce “sustained clinical recovery” in COVID-19 patients. FDA-approved or authorized oral ther...