News & Events zu 60 Degrees Pharmaceuticals Inc (SXTP)SXTP60 Degrees Pharmaceuticals Inc

60 Degrees Pharmaceuticals Expands Research with USM on Vector-Borne Diseases

60 Degrees Pharmaceuticals announced expansion of its vector-borne disease research portfolio through a sponsored research agreement with The University of Southern Mississippi, or USM, to assess the therapeutic potential of castanospermine-a naturally occurring iminosugar derived from the Australian Chestnut-in nonclinical models of alpha-gal syndrome.

60 Degrees Pharmaceuticals Reports Tafenoquine Treatment Results

60 Degrees Pharmaceuticals announced clinical and molecular results from the first five patients to complete treatment with tafenoquine-containing combination regimens in its expanded access study of relapsing babesiosis in immunosuppressed patients. All five patients reported being much improved or very much improved, and each had negative conventional polymerase chain reaction test results for Babesia documented during treatment or subsequent follow-up. Four of the five patients, or 80%, were also nonreactive on a highly sensitive blood-donor nucleic acid amplification test for Babesia performed on blood collected after treatment. Two additional patients remain on treatment, bringing total enrollment to seven. The study remains open pending potential discussions with the FDA. The company expects to unblind its separate randomized, placebo-controlled study of tafenoquine or placebo added to standard-of-care therapy in patients hospitalized for babesiosis in January 2027.

60 Degrees Pharmaceuticals Plans to Conclude Enrollment in Severe Babesiosis Study

60 Degrees Pharmaceuticals 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, or sNDA, meeting with the 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", 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, 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, in the first three patients enrolled in its expanded access study of tafenoquine combined with atovaquone-containing regimens in relapsing, treatment-refractory babesiosis. Final screening data from two additional patients are expected in early November. 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. No FDA-approved treatment or vaccine exists for human babesiosis. While tafenoquine is approved for the prevention of malaria, it is not currently approved by FDA for the treatment or prevention of babesiosis.