WASHINGTON - The U.S. Food and Drug Administration (FDA) has awarded orphan drug designation to 60 Degrees Pharmaceuticals for its investigational drug tafenoquine, intended to treat acute babesiosis. This designation provides the company with market exclusivity, tax credits, and fee waivers, aiming to encourage the development of treatments for rare diseases.
Babesiosis is an infectious disease caused by the Babesia parasite, transmitted by the same ticks that spread Lyme disease. It poses a significant risk, especially to the elderly and those with weakened immune systems. With the prevalence of Lyme disease, up to 10 percent of patients may also be co-infected with Babesia, indicating a potential patient population for tafenoquine.
Recent animal studies suggest tafenoquine could be a promising treatment for acute babesiosis. Geoff Dow, PhD, CEO of 60 Degrees Pharmaceuticals, expressed optimism about the drug's potential following the FDA's recognition.
The company, in collaboration with Tufts Medical Center in Boston, is set to begin the world's first clinical trial to assess tafenoquine's efficacy and safety in human patients with acute babesiosis. The trial will start recruitment on Thursday, aiming to enroll at least 24 hospitalized patients. Additional recruitment at university hospitals in the Northeast U.S. is also anticipated.
Tafenoquine is currently approved in the United States for malaria prophylaxis under the brand name ARAKODA®. However, it has not yet been approved for the treatment or prevention of babesiosis. The upcoming clinical trial will be a randomized, double-blind, placebo-controlled study, with the primary endpoints being the time to sustained clinical resolution of symptoms and time to molecular cure.
The drug's efficacy and safety for malaria prevention have been established through several clinical trials. ARAKODA® is available by prescription for individuals traveling to malaria-endemic areas.
60 Degrees Pharmaceuticals, which specializes in infectious diseases treatment, has received support from the U.S. Department of Defense and private investors. The company's mission is to develop new medicines that address significant health concerns globally.
This news is based on a press release statement from 60 Degrees Pharmaceuticals.
In other recent news, 60 Degrees Pharmaceuticals has been a focal point of attention in the investment world due to its recent financial and research developments. Ascendiant Capital maintained its Buy rating on the company, citing a strong first-quarter performance that surpassed expectations. Gross profit for the quarter was reported at $81,000, signaling that 60 Degrees' ARAKODA for Malaria has reached a profitable scale. However, operating expenses were higher than anticipated, totaling $1.8 million, but non-operating items compensated for the increased expenses, leading to a net profit of $309,000.
In addition to its financial performance, 60 Degrees Pharmaceuticals is set to initiate a clinical trial to evaluate the safety and efficacy of tafenoquine, a medication currently approved for malaria prophylaxis, in treating babesiosis. The company has also announced sponsorship of a pilot study to investigate the use of tafenoquine for treating babesiosis in dogs.
Meanwhile, the U.S. Food and Drug Administration (FDA) is scheduled to provide comments on the company's babesiosis trial protocol in April 2024.
InvestingPro Insights
As 60 Degrees Pharmaceuticals (SXTP) advances with its clinical trials for the investigational drug tafenoquine, investors are closely monitoring the company's financial health and market performance. An important InvestingPro Tip for SXTP is that the company holds more cash than debt on its balance sheet, which could provide it with the necessary liquidity to fund ongoing research and operations without the immediate need for external financing.
Another notable InvestingPro Tip is that analysts anticipate sales growth in the current year for SXTP. This projection may be tied to the potential market exclusivity benefits awarded by the FDA's orphan drug designation, which could translate into a competitive advantage should tafenoquine become approved for the treatment of acute babesiosis.
Looking at the real-time data from InvestingPro, SXTP has experienced a significant return over the last week, with a 17.31% increase in price total return. Additionally, the company has seen a robust 55.11% return over the last month. These metrics suggest a positive market reaction to recent developments, although the company's stock has taken a considerable hit over the last six months, with a -54.89% return.
Investors interested in a deeper analysis of 60 Degrees Pharmaceuticals can uncover more InvestingPro Tips by visiting https://www.investing.com/pro/SXTP. There are currently 16 additional tips available, offering insights into the company's financial health and market outlook. For those considering an InvestingPro subscription, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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