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Sixty 160 Degrees Pharma 60 Degrees Pharmaceuticals Plans January 2027 Hospitalized Babesiosis Data Readout ; Will Seek Pre - SNDA Meeting with FDA October 6 , 2026 12:10 PM EDT • After a scheduled interim analysis of the severe babesiosis study on October 1 , 2026 , the DSMB recommended completing the study with the originally planned number of patients ( N = 33 ) ; the study remains blinded • As of the same date , the Company had enrolled 30 patients • Given the limited incremental statistical power from enrolling three additional patients and the seasonal nature of babesiosis , which would otherwise delay unblinding until fall 2027 , the Company has decided to conclude enrollment and proceed with unblinding . Primary and secondary endpoint results are expected in January 2027 • No safety signals were identified in the study • Published case reports and the Company's prospective expanded access study support the potential of tafenoquine - containing regimens in treatment - refractory , relapsing babesiosis , and additional data will be disclosed from this study in early November 2026 • Company sees a viable regulatory pathway for severe and / or treatment - refractory disease and will request a pre - sNDA meeting with FDA in January 2027 to discuss data requirements , patient population , regulatory pathway , and post - marketing requirements WASHINGTON , Oct. 06 , 2026 ( GLOBE NEWSWIRE ) -- 60 Degrees Pharmaceuticals , Inc. ( NASDAQ : SXTP ; SXTPW ) ( " 60 Degrees " or the " Company " ) , a pharmaceutical company that develops and commercializes new medicines for vector - borne disease , today announced that it intends to conclude enrollment in its randomized clinical study of tafenoquine in patients hospitalized with severe babesiosis at 30 subjects . The Company plans to unblind the study and report its primary and secondary endpoint results in January 2027 , and to submit a request for a pre- supplemental New Drug Application ( SNDA ) meeting with the U.S. Food and Drug Administration ( FDA ) that same month . 60 Degrees is the sponsor of the double - blind , randomized , multisite , placebo - controlled clinical trial entitled " Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis " ( NCT06207370 ) , which is evaluating the efficacy and safety of tafenoquine in treating severe babesiosis in humans . Patients were enrolled at multiple sites in the U.S. , including Tufts Medical Center , Rhode Island Hospital , Yale University , Brigham and Women's Hospital , and Westchester Medical Center . The DSMB conducted an interim analysis of time to sustained clinical resolution of babesiosis , the study's primary endpoint , and time to molecular clearance of Babesia parasites , a key secondary endpoint . Following its review , the DSMB recommended completing the initially planned enrollment of 33 patients . As of October 1 , 2026 , the Company had enrolled 30 subjects . Due to the marginal impact an additional three subjects would have on power to detect a difference on the study endpoints and the seasonality of babesiosis and its potential to delay unblinding by a year if additional subjects were to be recruited , the Company intends to proceed with final analysis of the enrolled population . The DSMB's recommendation does not establish whether the study met its endpoints ; those results will be determined following unblinding and final analysis . The DSMB analysis did not identify any safety issues . A growing body of published case reports suggests that tafenoquine , administered in combination with atovaquone - containing regimens for at least eight weeks , may achieve a high cure rate in high - risk patients with treatment - refractory , relapsing babesiosis . Consistent with these reports , the Company has confirmed molecular cure , using a highly sensitive nucleic acid amplification test ( NAT ) , in the first three patients enrolled in its expanded access study of tafenoquine combined with atovaquone - containing regimens in relapsing , treatment - refractory babesiosis ( " Expanded Use in Persistent B. Microti Babesiosis " - NCT06478641 ) . Final screening data from two additional patients are expected in early November 2026 . Irrespective of the ultimate results of the severe babesiosis study to be reported in January , the Company believes an approval pathway based on case reports in the treatment - refractory population is possible . The Company intends to request a pre - sNDA meeting with FDA to discuss the clinical evidence and data requirements for an SNDA submission for tafenoquine treatment of babesiosis . Should the data package be supported by literature and expanded access cases only , the Company plans to ask FDA to consider NAT - based molecular clearance as a surrogate endpoint reasonably likely to predict clinical benefit , potentially supporting an accelerated approval pathway . The Company would also propose a post - approval confirmatory study in an appropriate patient population . The availability of an accelerated approval pathway and the adequacy of the submission will be subject to FDA review .