60 Degrees Pharmaceuticals Launches Babesiosis Drug Trial. Investing.com

WASHINGTON – 60 Degrees Pharmaceuticals Inc. (NASDAQ: SKSTP; SKSTPV), a company specializing in the development of treatments for infectious diseases, has initiated a clinical trial in collaboration with Brigham and Women’s Hospital (BVH) to evaluate the safety and efficacy of tafenoquine, a drug currently approved for malaria prophylaxis, in combination 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 Medically (TASE:) Center, Yale University and Rhode Island Hospital. The trial will focus on two primary endpoints: time to sustained clinical resolution of symptoms and time to molecular cure as determined by a US Food and Drug Administration (FDA)-approved nucleic acid assay. Recruitment for the trial is set to begin in the summer of 2025, with a goal of enrolling 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 disease caused by the Babesia parasite, which is often found as a co-infection with Lyme disease. The disease can be life-threatening, especially in the elderly and immunocompromised. An increase in babesiosis cases has been reported in the northeastern United States.

Geoffrey Dove, Ph.D., CEO and President of 60 Degrees Pharmaceuticals, expressed optimism about the collaboration with BVH, which aims to address the unmet medical need for effective treatments for babesiosis and potentially improve the clinical trial enrollment process during the 2025 tick season.

Tafenoquine, sold under the name ARAKODA®, was approved by the FDA for the prevention of malaria in 2018. The drug has been evaluated in several randomized trials for up to six months of use. However, it is not approved for the treatment or prevention of babesiosis.

The company estimates that the total cumulative available market for tafenoquine for babesiosis could exceed 400,000 patients by the end of US patent protection in December 2035. Despite this potential, financial metrics from InvestingPro show significant challenges, including negative gross margins and projected earnings declines for the current year. InvestingPro subscribers can access 12 additional key insights on SKSTP’s financial health and growth prospects. It is important to note that although a series of case studies suggested a high cure rate for tafenoquine in immunosuppressed patients with relapsing babesiosis, the drug’s efficacy in babesiosis has yet to be proven and is not currently an FDA-approved indication.

This article is based on a press release issued by 60 Degrees Pharmaceuticals.

In other recent news, 60 Degrees Pharmaceuticals has seen significant progress. The pharmaceutical company received shareholder approval for several key proposals at the Special Shareholders’ Meeting. This includes the exercise of warrants, an amendment to the equity incentive plan and a reverse stock split.

Additionally, 60 Degrees Pharmaceuticals has launched a pilot program to promote its anti-malaria drug, ARAKODA. The company’s second-quarter revenue doubled, largely due to a 288% increase in ARAKODA drugstore shipments, despite a net loss due to increased operating expenses.

Furthermore, the company disclosed the sale of shares and warrants in a private placement, with HC Wainwright & Co. as an exclusive placement agent. The company has also initiated a clinical trial for the treatment of babesiosis and received orphan drug designation from the FDA 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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