60 Degrees Pharmaceuticals advances study on babesiosis treatment

WASHINGTON - 60 Degrees Pharmaceuticals, a NASDAQ-listed company specializing in infectious disease treatments, has received ethics approval for a study to explore the use of tafenoquine in treating babesiosis, an often serious tick-borne illness. The study aims to confirm an 80% cure rate observed in a previous case series by Yale School of Public Health.

Babesiosis is caused by Babesia parasites, which are transmitted through the bite of the black-legged tick, the same vector responsible for Lyme disease. The disease is particularly dangerous for the elderly and those with weakened immune systems, with symptoms ranging from fevers and chills to life-threatening complications.

The current study will involve immunosuppressed patients and will be part of a broader clinical program that includes trials for hospitalized patients with acute babesiosis and another for chronic cases of the disease. While tafenoquine is already approved in the United States for malaria prophylaxis under the name ARAKODA, it has not yet been approved by the U.S. Food and Drug Administration (FDA) for the treatment or prevention of babesiosis.

60 Degrees Pharmaceuticals' CEO, Geoffrey Dow, PhD, expressed urgency in advancing the clinical program due to rising babesiosis rates in the United States and the severe nature of the illness in vulnerable populations. The company's program for tafenoquine in babesiosis encompasses three studies targeting different patient populations, with a New Drug Application planned for submission to the FDA in the second quarter of 2026.

The company estimates the total accessible market for tafenoquine as a babesiosis treatment could reach over 375,000 patients with chronic babesiosis, in addition to 38,000 acute cases. This is apart from the potential use of ARAKODA for malaria prophylaxis among 1.7 million travelers.

The safety of tafenoquine for malaria prophylaxis has been established through several clinical trials, but its efficacy for babesiosis remains to be proven. 60 Degrees Pharmaceuticals, founded in 2010, continues to conduct research and collaborate with institutions to further develop treatments for infectious diseases.

This report is based on a press release statement.

In other recent news, 60 Degrees Pharmaceuticals received an orphan drug designation from the U.S. Food and Drug Administration for tafenoquine, an investigational drug aimed at treating acute babesiosis.

This designation offers market exclusivity, tax credits, and fee waivers, incentivizing the development of treatments for rare diseases. The company is set to conduct the world's first clinical trial, in collaboration with Tufts Medical Center, to assess tafenoquine's efficacy and safety in human patients with acute babesiosis.

Recent financial reports show 60 Degrees Pharmaceuticals surpassing expectations with a gross profit of $81,000 for the first quarter, as reported by Ascendiant Capital. Despite higher than anticipated operating expenses totaling $1.8 million, non-operating items offset the increase, resulting in a net profit of $309,000. Ascendiant Capital maintains its Buy rating on the company, adjusting future earnings estimates based on these results.

The company is also set to initiate a clinical trial for the use of tafenoquine in treating babesiosis, an emerging tick-borne illness in the United States. This trial, the first of its kind, will assess a triple combination therapy including tafenoquine and the standard of care, atovaquone-azithromycin, in hospitalized patients.

InvestingPro Insights

As 60 Degrees Pharmaceuticals forges ahead with its clinical program for tafenoquine, the company's financial metrics provide a backdrop to its operational strategies. According to InvestingPro data, the company's revenue in the last twelve months as of Q1 2024 stood at 0.38M USD, with a staggering quarterly revenue growth of 580.65%. Despite this growth, the company's gross profit margin was deeply negative at -262.72%, indicating costs significantly outstripping revenues.

Investors have taken note of these financial challenges, as reflected in the stock's performance. The 1-year price total return as of this year indicates a steep decline of -95.06%, underscoring market concerns. An InvestingPro Tip points out that the company holds more cash than debt, which could provide some financial flexibility in its operations. However, another tip suggests that analysts do not anticipate the company will be profitable this year, aligning with the observed negative net income and gross profit margins.

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