Why Is Infection Treatment Focused-60 Degrees Pharmaceuticals Stock Soaring Today?

60 Degrees Pharmaceuticals Inc SXTP announced the approval of an Investigational Review Board (IRB) sanctioned Phase 2A clinical study. 

The study aims to investigate the efficacy and safety of the Arakoda regimen of tafenoquine in combination with standard-of-care medications for hospitalized babesiosis patients at lower risk of relapse.

Additionally, due to a federal holiday, the FDA rescheduled the company's previously announced January 15 Type C meeting to January 17, 2024. 

The agenda and all material submitted by SXTP to FDA to support the Type C meeting remain unchanged.

Babesiosis is a tick-borne illness. The total number of babesiosis patients in the U.S. may be approximately 47,000 per year based on the observation of 476,000 Lyme infections and an estimated babesiosis coinfection rate of 10%.

Tafenoquine is approved for malaria prophylaxis in the U.S. under the product name Arakoda. 

The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months.

The Phase IIA study will assess the safety and efficacy of oral tafenoquine plus standard of care versus placebo plus standard of care.

The study is expected to enroll at least 24 patients in the U.S., beginning in Q2 2024. 

The study's primary endpoint will be time to molecular cure as determined by an FDA-approved nucleic acid test. 

Price Action: SXTP shares are up 46.30% at $1.32 on the last check Tuesday.