60 Degrees Pharmaceuticals, Inc. Warrant - SXTPW STOCK NEWS

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has signed clinical trial agreements with Yale University, Rhode Island Hospital, and Tufts Medical Center for its Tafenoquine Babesiosis Study. This marks the world's first randomized, double-blind, placebo-controlled trial evaluating tafenoquine's efficacy and safety in treating relapsing babesiosis. The study aims to enroll 24-33 hospitalized patients, with interim results expected by September 2025.

Babesiosis, a tick-borne illness, is becoming increasingly prevalent in the Northeast U.S. Recent case studies suggest tafenoquine combined with standard treatment shows high cure rates in immunosuppressed patients with relapsing babesiosis. The total accessible market for ARAKODA® (tafenoquine) for babesiosis in the U.S. is estimated at 400,000 patients through December 2035.

60 Degrees Pharmaceuticals announced IRB approval for an open-label study of the ARAKODA® regimen of tafenoquine to treat persistent babesiosis in immunocompromised patients. The study aims to replicate the 80% cure rate observed in an earlier Yale School of Public Health case series. Tafenoquine, approved for malaria prophylaxis in the U.S., has not been proven effective for babesiosis treatment or prevention. The increasing incidence of babesiosis, a tick-borne illness, particularly affects the elderly and immunosuppressed. This clinical program is now enrolling at Tufts Medical Center.

60 Degrees Pharmaceuticals (SXTP) has enrolled the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine in treating human babesiosis. The randomized, double-blind, placebo-controlled study aims to enroll 24-33 participants to assess time to sustained clinical resolution and molecular cure using an FDA-approved nucleic acid test. Tafenoquine, already approved for malaria prophylaxis under the name ARAKODA, has been designated as an orphan drug by the FDA for this new indication. Babesiosis, a tick-borne disease, poses significant health risks, particularly for the elderly and immunosuppressed.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has received FDA orphan drug designation for its tafenoquine candidate, aimed at treating acute babesiosis. This designation offers benefits such as market exclusivity, tax credits, and exemption from certain FDA fees.

The company has partnered with Tufts Medical Center to conduct the first clinical trial evaluating tafenoquine's efficacy and safety in humans, starting June 13, 2024. The trial will involve at least 24 hospitalized patients and may expand to additional sites in the Northeast U.S.

Babesiosis, a disease transmitted by ticks, can be life-threatening, especially in elderly or immunosuppressed individuals. Up to 47,600 of the estimated 476,000 Lyme disease patients in the U.S. each year may be co-infected with Babesia.

CEO Geoff Dow emphasized the need for new therapeutic options, highlighting promising animal study results for tafenoquine.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has partnered with Tufts Medical Center to conduct the first clinical trial evaluating the safety and efficacy of tafenoquine for treating babesiosis in humans. Enrollment will begin after a site initiation visit on June 13, 2024, in Boston. The study will recruit at least 24 hospitalized patients. Babesiosis, a tick-borne disease, is becoming a significant health concern, especially among elderly and immunosuppressed patients. The company is also negotiating with other university hospitals in the Northeast U.S. to expand recruitment. Tafenoquine, known under the brand name ARAKODA®, is approved for malaria prophylaxis but not for babesiosis.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) will fund a study at North Carolina State College of Veterinary Medicine to test for Babesia spp in chronic fatigue syndrome (CFS) patient samples. The study will use PCR testing to detect the presence of the Babesia spp parasites in patients with chronic fatigue and neurologic symptoms. This 12-month study commences in May 2024.

Babesia spp is known to cause babesiosis, a potentially life-threatening disease in immunocompromised individuals. With an estimated 47,000 cases of babesiosis annually in the U.S, the CDC estimates CFS affects 3.3 million Americans. CEO Geoff Dow emphasized that the study aligns with the company's mission to understand the link between infectious diseases and chronic symptoms.

60 Degrees Pharmaceuticals (NASDAQ: SXTP; SXTPW) reported a significant increase in its financial performance for Q1 2024. The company saw net product revenues surge by 515% year-over-year to $105.7 thousand, driven by domestic sales of ARAKODA®. Gross profit improved from a loss of $55.9 thousand in Q1 2023 to a profit of $51.0 thousand in Q1 2024. However, operating expenses rose to $1.41 million, up from $0.899 million, due to higher R&D costs, commercial promotional costs, and other expenses.

Net income for common shareholders stood at $0.309 million, or $0.03 per share, a marked improvement from a net loss of $2.601 million, or ($1.13) per share, in Q1 2023. This turnaround is attributed to a change in the fair value of liabilities and reduced interest expenses. Business highlights include the initiation of planning for a clinical study for tafenoquine for babesiosis treatment following an FDA meeting, and the appointment of Kristen Landon as Chief Commercial Officer in February 2024.

60 Degrees Pharmaceuticals, a pharmaceutical company focusing on infectious diseases, announced a planned clinical trial of tafenoquine in treating babesiosis. This will be the first study of its kind in the U.S., aiming to address the unmet medical need for new treatment methods for babesiosis. The trial will assess the safety and efficacy of tafenoquine in combination with atovaquone-azithromycin. The Company's CEO, Dr. Geoff Dow, outlined the study protocol in response to the medical community's call for more research on babesiosis treatment.

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) has received comments from the FDA on the protocol for a clinical trial studying tafenoquine in treating babesiosis, a life-threatening tick-borne disease. The comments do not require material changes to the trial design. The Company is moving forward with trial planning and patient enrollment is expected to begin later in 2024.