60 Degrees Pharmaceuticals to Initiate Clinical Trial for Tick-Borne Disease Treatment
60 Degrees Pharmaceuticals (Nasdaq: SXTP) will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S. following a Type C meeting with the FDA. The company expects to initiate patient enrollment in the summer of 2024.
Babesiosis is a tick-borne illness affecting an estimated 47,000 Americans each year. Clinical complications include severe anemia, renal failure, cardiorespiratory failure and death.
Geoff Dow, Chief Executive Officer of 60 Degrees Pharmaceuticals, said, “Our recent Type C meeting with the FDA led to mutual alignment with respect to the design of a development plan to evaluate the ARAKODA® regimen of tafenoquine for treating people who are hospitalized with babesiosis.
“We are excited to advance this important study, as tick-borne illnesses such as babesiosis are emerging rapidly in the U.S. and can be life-threatening. Our aim is to bring a new treatment option to healthcare providers seeking a safe, effective solution to address the needs of their hospitalized patients diagnosed with this very serious condition.”
Highlights
Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®.
An estimated 47,000 cases of babesiosis occur in the United States each year and the incidence rate is steadily increasing. 10% of Lyme disease patients are co-infected with babesiosis.
Babesiosis is spread by the bite of an infected blacklegged tick. It can also be spread by transfusion of contaminated blood.
Most cases of babesiosis occur in coastal areas in the Northeast and upper Midwest, particularly in parts of New England, New York State, New Jersey, Wisconsin, Minnesota and in some European countries.
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60P successfully achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60P also collaborates with prominent research organizations in the U.S., Australia and Singapore. 60P’s mission has been supported through in-kind funding from the DOD and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60P is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.
