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60 Degrees Pharmaceuticals Receives FDA Comments on Tafenoquine-Babesiosis Clinical Trial Protocol; No Material Changes Required
Trial planning and execution to proceed as planned WASHINGTON, May 02, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"Trial planning and execution to proceed as planned WASHINGTON, May 02, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has provided comments on the protocol of a planned clinical trial that will study the use of tafenoquine in treating babesiosis. Babesiosis, a potentially life-threatening disease in immunosuppressed patients, is a tick-borne illness steadily emerging in the United States. The FDA had some questions and recommendations that will be addressed. Nothing in the comments requires the Company to change the trial design/protocol in a material way. The Company is continuing preparatory actions to facilitate initiation of patient enrollment later in 2024. The Company conducted a Type C regulatory meeting with the FDA on January 17, 2024, at which a synopsis of the current version of the tafenoquine for babesiosis study protocol was discussed. In February 2024, the Company submitted a full protocol to the FDA under its malaria Investigational New Drug (“IND”) application, incorporating FDA feedback from the January 17, 2024 meeting. Because the protocol was submitted under an existing (rather than a new) IND application per the FDA’s advice, no formal statutory response time was required by the FDA. The FDA informed the Company in March 2024, however, that comments on that protocol would be provided by April 30, 2024. The FDA provided this feedback on April 26, 2024. 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 Babesiosis and the Tafenoquine StudyThis study is a randomized double-blind placebo-controlled trial anticipated to enroll at least 24 patients in the U.S. in 2024. The two main study endpoints will be time to sustained clinical resolution of symptoms of babesiosis and molecular cure as determined by a...