FDA Grants Orphan Drug Status to 60 Degrees Pharmaceuticals' Tafenoquine for Acute Babesiosis

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW), a company specializing in infectious disease treatments, has recently been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its investigational drug, tafenoquine, aimed at treating acute babesiosis. This designation is awarded to therapies that target rare diseases and offers several benefits including market exclusivity, tax credits, and exemption from certain FDA fees.

Babesiosis is an infectious disease transmitted through the bite of the black-legged tick, the same vector responsible for Lyme disease. It can be life-threatening, particularly for the elderly and immunocompromised individuals. Approximately 10% of Lyme disease patients might concurrently suffer from babesiosis, translating to roughly 47,600 people annually in the U.S. alone.

Geoff Dow, PhD, CEO of 60 Degrees Pharmaceuticals, emphasized the significance of this FDA designation, stating that recent animal studies of tafenoquine have shown promising results. This recognition underscores the demand for additional therapeutic options for combating acute babesiosis, a potentially fatal condition. The company is optimistic about the outcomes of its upcoming clinical trials and aims to secure approval for using tafenoquine to treat babesiosis.

The company also announced a collaboration with Tufts Medical Center in Boston to conduct the first clinical trial to assess the efficacy and safety of tafenoquine in treating human babesiosis. The study is set to begin on June 13, 2024, will involve at least 24 hospitalized patients, and additional recruitment sites will be established at notable university hospitals in the Northeastern U.S.

Tafenoquine is already approved in the U.S. under the brand name ARAKODA® for malaria prophylaxis. Its safety has been evaluated in multiple randomized, controlled trials lasting up to six months. While not yet proven for babesiosis treatment, several case reports indicate its off-label use for the condition in the U.S.

The forthcoming trial will be a randomized, double-blind, placebo-controlled study. It aims to evaluate the safety and efficacy of tafenoquine versus placebo in patients hospitalized with babesiosis. Participants will also receive standard antimicrobial treatments. Primary outcomes will include the duration for the clinical resolution of symptoms and the time to molecular cure as determined by FDA-approved tests. The study plans to recruit between 24 and 33 patients, with an interim analysis to assess the significance and decide if further recruitment is necessary.

60 Degrees Pharmaceuticals, founded in 2010, has a mission centered on developing treatments for infectious diseases. The company's flagship product, ARAKODA® (tafenoquine), received FDA approval in 2018 for malaria prevention. The company collaborates with research organizations globally and has received support from the U.S. Department of Defense and private investors like Knight Therapeutics Inc. Headquartered in Washington D.C., the company also operates a subsidiary in Australia.

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