60 Degrees Pharmaceuticals Inc SXTP announced that, following a Type C meeting held on January 17, 2024, with the FDA, the company will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S.
An estimated 47,000 cases of babesiosis (i.e., infections caused by red blood cell parasites similar to malaria transmitted by deer tick bites) occur in the U.S. yearly.
An estimated 10% of Lyme disease patients are co-infected with babesiosis. The mortality rate of babesiosis patients who have cardiac complications approaches 10%.
Babesiosis is spread by the bite of an infected black-legged tick, Ixodes scapularis. It can also be spread by transfusion of contaminated blood.
In advance of the meeting, 60P provided the FDA with 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 to initiate patient enrollment in the summer of 2024.
Tafenoquine is approved for malaria prophylaxis in patients aged 18 years and older in the U.S. under the product name Arakoda.
Tafenoquine has not been proven effective for treating or preventing babesiosis.
The study is anticipated to enroll patients in the U.S. beginning in the summer of 2024. The study will be conducted at three hospitals in the northeastern U.S.
Price Action: SXTP shares are up 16% at $0.75 on the last check Monday.
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