60 Degrees Reports 100% Clinical Improvement, Negative PCR in Completed Babesiosis Patients

summarizeSummary

On Oct. 27, 2026, 60 Degrees reported that all five patients completing its expanded access babesiosis study improved clinically and tested negative on conventional PCR, with four of five negative on a highly sensitive NAT assay 66–120 days after tafenoquine. Six of seven patients (85.7%) treated with tafenoquine–atovaquone combinations remained retreatment-free for at least 12 weeks, against a model-estimated 23.5% expected retreatment-free rate with conventional treatment, approximately 3.6 times that rate. Next on the regulatory path is the January 2027 unblinding of the company's randomized hospitalized-babesiosis trial.

check_boxKey Events · Product Development and Regulatory · SXTP

• New · Oct 27 · GlobeNewswire

  Retreatment-Free Durability Reported

  Six of seven patients (85.7%) treated with tafenoquine–atovaquone combinations remained retreatment-free for at least 12 weeks after treatment, against a model-estimated 23.5% expected retreatment-free rate with conventional treatment, approximately 3.6 times that rate. An exploratory Cox comparison (approximate patient-clustered score test) was statistically significant, two-sided p = 0.019.

• Updated · Oct 27 · GlobeNewswire

  All Five Completed Patients Improved, Reported Oct. 27, 2026

  On Oct. 27, 2026, 60 Degrees reported that all five completed expanded access patients (100%) reported much or very much improved clinical outcomes and tested negative for Babesia on conventional PCR.

• Updated · Oct 27 · GlobeNewswire

  80% Negative on Sensitive NAT at 66–120 Days

  Four of five completed patients (80%) were nonreactive on the highly sensitive blood-donor NAT assay, which the company describes as 500-fold more sensitive than conventional PCR, tested 66–120 days after tafenoquine; the fifth had a reactive NAT despite a negative Mayo Clinic PCR.

• Enrollment at Seven Patients

  Two additional patients remain on treatment, bringing total enrollment to seven, and the study stays open pending potential FDA discussions.

• Accelerated Approval Strategy Outlined

  The company plans to pursue accelerated approval with post-treatment NAT nonreactivity as a surrogate endpoint plus a postmarketing confirmatory study, if the efficacy section rests primarily on immunosuppressed relapsing-babesiosis data.

auto_awesomeAnalysis · SXTP · Life Sciences

For a tiny company whose lead asset, tafenoquine, is approved only for malaria prevention, these results are encouraging: all five patients who finished the expanded access babesiosis study improved clinically and cleared Babesia on conventional PCR, and four of five were also negative on a blood-donor NAT assay roughly 500-fold more sensitive than PCR, tested 66–120 days after tafenoquine. The durability signal is the more striking part: six of seven patients (85.7%) on tafenoquine–atovaquone combinations stayed retreatment-free for at least 12 weeks, against a model-estimated 23.5% expected retreatment-free rate with conventional treatment, approximately 3.6 times that rate, with an exploratory Cox comparison (approximate patient-clustered score test) statistically significant at two-sided p = 0.019. The caveats are substantial, however. The sample is five patients in an uncontrolled study, and the company itself flags that regulators may not accept NAT nonreactivity as a surrogate for cure. The real test is the separate randomized hospitalized-babesiosis trial, which unblinds in January 2027 and would precede any pre-sNDA meeting. Against a going-concern backdrop, with cash previously disclosed as sufficient only into early October 2026, positive data help the story but do not by themselves fund the regulatory path.