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60 Degrees Pharma Announces IRB Approval of Phase IIA Study to Evaluate Tafenoquine for Babesiosis, an Emerging Tick-Borne Disease; Type C Meeting Re-Scheduled by FDA to January 17, 2024
Investigational Review Board (IRB) approval has been granted for 60 Degrees Pharma’s double-blind, placebo-controlled study to investigate tafenoquine for
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":" Investigational Review Board (IRB) approval has been granted for 60 Degrees Pharma’s double-blind, placebo-controlled study to investigate tafenoquine for treatment of hospitalized babesiosis patientsThe previously announced Type C meeting with FDA has been rescheduled by FDA from January 15 to January 17, 2024, due to a federal holiday WASHINGTON, Dec. 26, 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 today the approval of an Investigational Review Board (IRB) sanctioned Phase IIA clinical study. The study aims to investigate the efficacy and safety of the ARAKODA® regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse. Additionally, the U.S. Food and Drug Administration (FDA) rescheduled the Company’s previously announced January 15 Type C meeting to January 17, 2024, due to a federal holiday. The agenda and all material submitted by SXTP to FDA in support of the Type C meeting remain unchanged. Babesiosis is a potentially life-threatening, tick-borne illness steadily emerging in the United States. Total babesiosis patients in the U.S. may be approximately 47,000 per year based on the observation of 476,000 Lyme infections and an estimated babesiosis coinfection rate of 10 percent. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication. About the Phase IIA Tafenoquine for Babesiosis StudyThe Phase IIA study, titled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis,” is anticipated to enroll at least 24 patients in the U.S., beginning in Q2 2024. The primary endpoint of the study will be time to molecular cure as determined by an FDA-approved ...