60 Degrees Pharmaceuticals will initiate B-FREE, a Phase 2 open-label study of tafenoquine (marketed as Arakoda for malaria prophylaxis) in chronic babesiosis in early November, with a planned 12-month run. Positioned as the first clinical trial to evaluate a potential new therapeutic for chronic babesiosis, the study will enroll up to 100 patients and test a 90-day tafenoquine regimen. The primary endpoint centers on the resolution of severe fatigue at day 90 using the Multi-Dimensional Fatigue Inventory general fatigue subscale, with parasite eradication assessed through serial testing. A subset of participants will be confirmed using the FDA-approved RNA amplification assay employed by the American Red Cross for blood screening, alongside two broadly available CLIA-validated RT-PCR assays.
The strategic signal is clear: a small-cap sponsor is attempting to define—and pharmacologically treat—a controversial, poorly described condition where no FDA-approved options exist. By anchoring the trial in a patient-reported outcome and supplementing with high-sensitivity molecular testing, the company is probing whether regulators and payers will accept a blended evidence model for a disease state that sits at the intersection of infectious persistence and immune dysregulation. The open-label design telegraphs that this is a hypothesis-generating step rather than a registrational shot, but it is a deliberate move to shape the clinical and diagnostic groundwork for a future program.
This matters now because the epidemiology is moving faster than the evidence base. Babesiosis incidence is rising in endemic regions, and elderly and immunocompromised patients remain at the highest risk. And transfusion safety concerns have already driven blood-screening innovation that is not yet widely accessible in clinical care. Patients report prolonged fatigue and relapsing symptoms, while frontline HCPs face unclear diagnostic criteria and inconsistent test performance. For payers, any future coverage decision will hinge on objective confirmation of infection, a reproducible definition of “chronic” disease, and clinically meaningful changes in function beyond subjective fatigue scores. For patients and physicians, if tafenoquine shows a signal, G6PD testing and risk management will be essential prerequisites to any broader use.
Commercially, B-FREE exemplifies a 505(b)(2)-style repurposing play aimed at an orphan-leaning, underserved niche. If the study can correlate improvement in fatigue with reductions in parasite detection—particularly via stringent assays—it strengthens the case for a randomized, controlled follow-up and opens an orphan and rare-infectious disease pathway that could attract partnerships or non-dilutive funding. The company’s decision to crowdsource the study name and donate to patient organizations may help build advocacy momentum and accelerate recruitment—an increasingly common tactic as sponsors seek to convert patient voice into operational leverage.
The broader industry context is a convergence of three trends: the reallocation of antimicrobial R&D into targeted, higher-value niches; the rise of long-disease programs where PROs and RWE are central to evidentiary strategy; and the persistent diagnostic gap that can make or break development in infectious conditions. Success will depend on harmonizing endpoints, validators, and assays across research and real-world practice so that any signal translates to payer-ready narratives and prescriber confidence.
The next critical readouts will be feasibility metrics—recruitment pace, the proportion of objectively confirmed infections, and the alignment between parasitemia dynamics and functional recovery. The pivotal question for Commercial and Medical leaders is whether a PRO-led, diagnostics-anchored evidence package can advance a regulatory dialogue on chronic babesiosis—or whether the field will demand a parasite-clearance primary endpoint in a randomized design before unlocking meaningful market access.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
