60 Degrees Pharmaceuticals will proceed with a clinical study of tafenoquine in hospitalized babesiosis patients after a meeting with the FDA. The aim is to commence patient enrollment in the summer of 2024.
Shares of 60 Degrees Pharmaceuticals have risen 18% to 74 cents following the company's announcement that it will proceed with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S. This decision comes after a Type C meeting with the Food and Drug Administration (FDA).
Earlier, the stock had reached its 52-week low of 51 cents on Nov. 20 and experienced a 15% decline on Friday.
In preparation for the meeting, 60 Degrees Pharmaceuticals submitted an information package to the FDA. This package included a presentation highlighting the unmet medical need for a new therapeutic for hospitalized babesiosis patients, along with a detailed outline of the proposed study protocol.
During the meeting, the FDA expressed that the proposed study could potentially meet regulatory approval, as long as the company uses a clinical endpoint instead of a surrogate marker.
Based on this feedback, 60 Degrees Pharmaceuticals is currently revising its study protocol. The aim is to commence patient enrollment in the summer of 2024.
It's worth noting that while tafenoquine is approved for malaria prophylaxis in patients 18 years and older under the product name Arakoda, it has not been proven to be effective for treating or preventing babesiosis. As a result, it is not approved by the FDA for this indication.
Geoff Dow, the CEO of 60 Degrees Pharmaceuticals, stated, "Our recent Type C meeting with the FDA led to mutual alignment regarding the design of a development plan to evaluate the Arakoda regimen of tafenoquine for the treatment of people hospitalized with babesiosis."
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