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60 Degrees Pharma Announces IRB Approval of Clinical Study of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients with Persistent Babesia microti Despite Prior Treatment
WASHINGTON, July 09, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"WASHINGTON, July 09, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced ethics approval of an open label, expanded access study of the ARAKODA® regimen of tafenoquine in combination with standard of care regimens in immunosuppressed patients with persistent/relapsing babesiosis. The goal of the study is to confirm the findings of an 80 percent babesiosis cure rate in humans observed in a similar population in an earlier case series of tafenoquine completed by Yale School of Public Health (YSPH) in April 2024 and published in the journal, Clinical Infectious Diseases. The YSPH case series showed a cure rate (with a 95 percent confidence interval) of 80 percent (30-100 percent) in a series of five immunosuppressed patients who were administered weekly tafenoquine following a loading dose in combination with standard of care medications. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration (FDA) for such an indication. Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease. It may be life-threatening in elderly and immunosuppressed patients. “Tafenoquine is showing exciting promise in addressing babesiosis within various human patient populations,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow, PhD. “With babesiosis rates now rising in key regions of the United States and given the very serious nature of this tick-borne illness, especially in the elderly and immunocompromised people, we are moving quickly in an effort to confirm Yale’s observations while advancing the clinical program for hospitalized babesiosis patients which is now enrolling at Tufts Medical Center. Ultimat...