Could this malaria drug become a breakthrough babesiosis cure? Yale and 60 Degrees aim to find out

60 Degrees Pharmaceuticals, Inc. has announced a significant new collaboration with the Yale School of Medicine and the Yale School of Public Health, marking a step forward in the development of tafenoquine for the treatment and prevention of babesiosis. This announcement follows the formal signing of a Patent License Agreement, which gives 60 Degrees the rights to co-develop and commercialise tafenoquine for this purpose. While tafenoquine has existing U.S. Food and Drug Administration (FDA) approval for malaria prophylaxis, its use in babesiosis remains investigational.

This new agreement formalises ongoing research collaborations between the company and Yale-affiliated researchers, who have been studying the potential of tafenoquine to combat babesiosis—a growing tick-borne disease that remains an orphan indication in the United States. The agreement is intended to facilitate further clinical investigation and, potentially, regulatory approval for an alternative treatment in a therapeutic area with limited options.

What is babesiosis and why is new treatment research critical?

Babesiosis is an infectious disease caused by Babesia, a genus of protozoan parasites that invade and destroy red blood cells. Transmitted through the bite of the black-legged tick (also known as the deer tick), babesiosis has garnered increased attention due to its expanding geographic range and its tendency to co-occur with Lyme disease. The condition is of particular concern to older adults and individuals with compromised immune systems, in whom it can become life-threatening. According to public health data, up to 10% of Lyme disease patients may also be infected with Babesia, translating into nearly 47,600 potential coinfections per year in the U.S. based on an estimated annual Lyme case count of 476,000.

Despite its severity and rising prevalence, babesiosis remains an orphan disease with few treatment options. Current therapies are often based on antimicrobial combinations such as atovaquone and azithromycin or clindamycin and quinine. These treatments can be lengthy, have variable efficacy, and present challenges in terms of tolerability and relapse rates. There is an unmet clinical need for new, more effective, and better-tolerated drugs, particularly for severe cases.

What makes tafenoquine a promising candidate for babesiosis treatment?

Tafenoquine is an 8-aminoquinoline compound that was initially developed by the Walter Reed Army Institute of Research and approved in 2018 for the prevention of malaria under the brand name ARAKODA in the United States and KODATEF in Australia. The drug has a notably long terminal half-life of around 16 days, allowing for less frequent dosing compared to other antimalarial agents. This extended duration in the body could provide a therapeutic advantage in managing relapsing or persistent parasitic infections like babesiosis.

Although tafenoquine is not yet FDA-approved for treating babesiosis, clinical and preclinical data have pointed to its potential efficacy against the Babesia parasite. Published case studies and research literature have observed promising responses in patients with relapsing babesiosis who had failed standard treatments but responded to tafenoquine-based regimens. These preliminary findings have paved the way for more rigorous scientific evaluation.

What does the current clinical trial aim to prove?

The development push is currently anchored by an ongoing clinical trial (NCT06207370), sponsored by 60 Degrees Pharmaceuticals. This randomized, double-blind, placebo-controlled study is designed to assess the efficacy and safety of tafenoquine in patients hospitalised for babesiosis. The trial is being conducted across multiple academic medical centres in the United States, including Tufts Medical Center, Rhode Island Hospital, Yale University, and Brigham and Women’s Hospital.

Participants in the study will be treated with the current standard of care for babesiosis, with a subset receiving tafenoquine or a placebo in addition. The trial is structured to monitor two key outcomes: the time to sustained resolution of clinical symptoms and the time to molecular cure, as determined through an FDA-approved nucleic acid testing method. At least 24 patients—and up to 33—will be enrolled before the first interim analysis, which will assess statistical significance and allow for size re-estimation if necessary. This staged design gives researchers flexibility to adapt the study based on early results.

What does market performance reveal about 60 Degrees Pharmaceuticals?

60 Degrees Pharmaceuticals, listed on NASDAQ under the ticker SXTP, has demonstrated a volatile trading pattern over the past year. As of April 9, 2025, the stock is trading at $2.50 per share, reflecting a sharp 12.89% drop from the prior session. The day’s trading range spanned from a low of $2.26 to a high of $2.92, with trading volume reaching over 770,000 shares.

The company’s 52-week range paints a broader picture of volatility, with the stock fluctuating between $1.41 and an earlier high of $36.00. This dramatic shift underscores investor uncertainty tied to its early-stage pipeline and ongoing research expenditures. In its 2024 earnings report, 60 Degrees posted revenue of $681,345—marking a 168.7% increase from 2023. However, it also recorded a net loss of $8.43 million, widening from the previous year’s loss of $3.98 million. These figures indicate the company’s heavy investment in clinical research and development, particularly its push to advance tafenoquine as a treatment for babesiosis.

Market sentiment around the stock is currently mixed. While some analysts maintain a positive outlook, projecting a 12-month price target average of $17.34, this optimism remains tempered by the early clinical stage of its assets and lack of commercialised revenue-generating products. The target range, spanning from $17.17 to $17.85, suggests substantial potential upside—but only if the tafenoquine programme yields positive results and advances through regulatory channels.

Given the stock’s low trading price relative to projected targets, investors with a higher risk appetite may view SXTP as a speculative “buy,” contingent on successful trial outcomes. Others may opt for a cautious “hold” stance until further clinical data is released. Conservative investors are likely to remain on the sidelines due to uncertainty in both the regulatory and revenue outlook.

How does this initiative reflect broader pharmaceutical innovation trends?

The partnership between 60 Degrees Pharmaceuticals and Yale exemplifies a growing trend in drug repurposing—leveraging existing compounds with proven safety records for new disease indications. This approach can dramatically shorten development timelines while addressing urgent public health needs. In the case of tafenoquine, its established efficacy for malaria, coupled with a unique pharmacological profile, makes it a strong candidate for treating other parasitic infections like babesiosis.

Such initiatives also highlight the role of academic institutions in accelerating translational medicine. Yale’s participation not only adds scientific rigour to the tafenoquine programme but also enhances its credibility in regulatory and investor circles. If successful, this partnership could set a precedent for similar collaborations focused on under-addressed infectious diseases.

As tick-borne illnesses continue to rise, particularly in North America, the need for robust therapeutics is becoming increasingly urgent. Tafenoquine’s development for babesiosis could fill a critical treatment gap and pave the way for broader deployment of antimalarial compounds against emerging parasitic threats.

For 60 Degrees Pharmaceuticals, the path ahead hinges on clinical success, regulatory engagement, and market confidence. If it can demonstrate meaningful clinical outcomes in its ongoing trials, the company may not only transform patient care in a niche disease space but also regain investor momentum and reestablish its standing in the biopharmaceutical market.