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60 Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine Following Jan 17 FDA Meeting
Following a Type C meeting with FDA on January 17, 2024, 60 Degrees Pharma (60P) now plans to conduct a pivotal clinical study in support of a future
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"Following a Type C meeting with FDA on January 17, 2024, 60 Degrees Pharma (60P) now plans to conduct a pivotal clinical study in support of a future indication for tafenoquine for treatment of hospitalized babesiosis patientsPatient enrollment to begin in summer of 2024 WASHINGTON, Jan. 22, 2024 (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 that, following a Type C meeting held on January 17, 2024 with the US Food and Drug Administration (FDA), the Company will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S. In advance of the meeting, 60P provided to the FDA an information package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients. It also included a detailed outline of the proposed study protocol. The FDA indicated in remarks during the meeting that the proposed study could be sufficient for regulatory approval, provided the Company uses a clinical endpoint rather than a surrogate marker. 60P is now revising the study protocol in light of that feedback, with the goal of initiating patient enrollment in the summer of 2024. “Our recent Type C meeting with the FDA led to mutual alignment with respect to the design of a development plan to evaluate the ARAKODA® regimen of tafenoquine for treating people who are hospitalized with babesiosis,” said Geoff Dow, Chief Executive Officer of 60 Degrees Pharmaceuticals. “We are excited to advance this important study, as tick-borne illnesses such as babesiosis are emerging rapidly in the U.S. and can be life-threatening. Our aim is to bring a new treatment option to healthcare providers seeking a safe, effective solution to address the needs of their hospitalized patients diagnosed with this very serious condition.” 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 co-infection rate of 10 percent. Tafenoquine is approved for malaria prophylaxis in patients aged 18 years and older in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been...