WASHINGTON - The University of Kentucky is set to begin a Phase IIb clinical trial evaluating a novel treatment for vivax malaria, combining drug candidate SJ733 with the previously approved anti-malarial drug tafenoquine, 60 Degrees Pharmaceuticals announced Monday.
The study is a collaborative effort between the University of Kentucky and Eisai Co (OTC:ESAIY). Ltd., funded by the Global Health Innovative Technology Fund. The primary goal is to assess the safety, tolerability, and pharmacokinetics of a single-dose combination of SJ733 and tafenoquine, the active ingredient in 60 Degrees Pharma's ARAKODA.
SJ733, an oral ATP4 inhibitor of Plasmodium, has shown a favorable safety profile and rapid anti-parasitic effect in prior studies. The current treatment for vivax malaria, widely resisted by P. vivax in some regions, involves a three-day regimen of tafenoquine and chloroquine.
This trial aims to develop an effective single-dose treatment suitable for all patients with uncomplicated P. vivax malaria, potentially streamlining and improving the current therapeutic approach.
Dr. R. Kip Guy, the principal investigator of the study and Dean of the University of Kentucky College of Pharmacy, highlighted the limited advancements in treating P. vivax malaria, which affects an estimated 14 million people annually. He expressed optimism that this study could lead to significant improvements in global malaria treatment.
60 Degrees Pharmaceuticals is supplying tafenoquine and placebos for the trial. Tafenoquine was discovered by Walter Reed Army Institute of Research and approved by the U.S. Food and Drug Administration (FDA) in 2018 for malaria prophylaxis in adults.
The company has granted the University of Kentucky a right of reference to its regulatory file for ARAKODA to facilitate the FDA's review process for new study protocols and Investigational New Drug applications related to the trial.
The upcoming Phase IIb study will build upon the data collected from completed Phase I and IIa trials of SJ733, setting the stage for future pivotal Phase 3 studies.
60 Degrees Pharmaceuticals, founded in 2010, specializes in developing treatments for infectious diseases. The company achieved FDA approval for ARAKODA for malaria prevention in 2018 and has collaborated with research organizations in the U.S., Australia, and Singapore.
This news is based on a press release statement from 60 Degrees Pharmaceuticals.
InvestingPro Insights
As 60 Degrees Pharmaceuticals embarks on a Phase IIb clinical trial for a promising vivax malaria treatment, investors are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, the company holds more cash than debt on its balance sheet, which could provide a degree of financial stability as it continues to fund research and development activities.
Despite the challenges faced by the biotech sector, analysts anticipate sales growth for 60 Degrees Pharmaceuticals in the current year, signaling potential market confidence in the company's pipeline and strategic direction. This optimism is tempered by concerns over the company's cash burn rate, which InvestingPro Tips highlight as a critical factor to watch, as it could affect the company's ability to sustain long-term research projects without seeking additional funding.
InvestingPro Data reveals a snapshot of the company's financial metrics, which include a negative Price/Earnings (P/E) Ratio of -0.29 and a Price/Book (P/B) Ratio of -0.43, reflecting the company's current lack of profitability. Moreover, with a significant Revenue Growth (Quarterly) of 580.65%, the company demonstrates a potential for rapid expansion, albeit from a small base. These figures underscore the high-risk, high-reward nature of investing in biotech firms like 60 Degrees Pharmaceuticals.
For those interested in a deeper dive into the company's financials and future prospects, InvestingPro offers additional tips. Currently, there are 16 more InvestingPro Tips available for 60 Degrees Pharmaceuticals, which can be accessed to help investors make more informed decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.