WASHINGTON - 60 Degrees Pharmaceuticals Inc. (NASDAQ: SXTP; SXTPW), a company specializing in the development of treatments for infectious diseases, has initiated a clinical trial in collaboration with Brigham and Women’s Hospital (BWH) to evaluate the safety and efficacy of tafenoquine, a drug currently approved for malaria prophylaxis, combined with standard treatments for babesiosis in hospitalized patients.
The study is a randomized, double-blind, placebo-controlled trial that also includes research sites at Tufts Medical (TASE:PMCN) Center, Yale University, and Rhode Island Hospital. The trial will focus on two primary endpoints: the time to sustained clinical resolution of symptoms and the time to molecular cure as determined by a nucleic acid test approved by the U.S. Food and Drug Administration (FDA). Recruitment for the trial is set to begin in the summer of 2025, aiming to enroll between 24 and 33 patients, with an interim analysis expected in early 2026. While the company maintains a healthy current ratio of 5.26 and holds more cash than debt, InvestingPro analysis indicates a rapid cash burn rate that investors should monitor.
Babesiosis is a tick-borne illness caused by the Babesia parasite, which is often found as a co-infection with Lyme disease. The disease can be life-threatening, particularly in the elderly and immunocompromised individuals. The Northeast U.S. has seen a rise in babesiosis cases.
Geoffrey Dow, Ph.D., CEO and President of 60 Degrees Pharmaceuticals, expressed optimism about the collaboration with BWH, which aims to address the unmet medical need for effective babesiosis treatments and potentially improve the clinical trial enrollment process during the tick season of 2025.
Tafenoquine, marketed under the name ARAKODA®, was approved by the FDA for malaria prevention in 2018. The drug has been evaluated in several randomized trials for up to six months of use. However, it has not been approved for the treatment or prevention of babesiosis.
The company estimates that the total cumulative accessible market for tafenoquine for babesiosis could exceed 400,000 patients through the end of U.S. patent protection in December 2035. Despite this potential, financial metrics from InvestingPro show significant challenges, including negative gross profit margins and projected earnings decline for the current year. Subscribers to InvestingPro can access 12 additional key insights about SXTP's financial health and growth prospects. It is important to note that while a case study series suggested a high cure rate for tafenoquine in immunosuppressed patients with relapsing babesiosis, the drug's effectiveness for babesiosis has yet to be proven and is not currently an FDA-approved indication.
This article is based on a press release statement issued by 60 Degrees Pharmaceuticals.
In other recent news, 60 Degrees Pharmaceuticals has seen significant developments. The pharmaceutical company received shareholder approval for several key proposals at its Special Stockholders Meeting. These include the exercise of warrants, an amendment to its equity incentive plan, and a reverse stock split.
In addition, 60 Degrees Pharmaceuticals launched a pilot program to promote its antimalarial medication, ARAKODA. The company's Q2 revenue doubled, largely due to a 288% increase in pharmacy deliveries of ARAKODA, despite a net loss due to increased operating expenses.
Furthermore, the company disclosed a private placement sale of shares and warrants, with H.C. Wainwright & Co. as the exclusive placement agent. The company also initiated a clinical trial for the treatment of babesiosis and received FDA Orphan Drug Designation for the same. Ascendiant Capital maintains its Buy rating on 60 Degrees Pharmaceuticals. These are some of the recent developments within the company.
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