60 Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine After Jan 17 FDA Meeting

 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.

https://www.globenewswire.com/news-release/2024/01/22/2812966/0/en/60-Degrees-Pharma-Plans-Pivotal-Babesiosis-Study-with-Tafenoquine-Following-Jan-17-FDA-Meeting.html