Designed Platform Experiment Finds Fluoxamine COVID Advantages
Pharma Tech Outlook

Designed Platform Experiment Finds Fluoxamine COVID Advantages

Pharma Tech Outlook | Tuesday, September 21, 2021

Cytel has participated in a large platform trial evaluating repurposed medicines as COVID-19 treatments (the TOGETHER Trial).

FREMONT, CA: Fluvoxamine, an antidepressant approved for treating depression related to COVID-19, has shown other benefits according to a platform research study conducted by the TOGETHER Trial, which featured significant design and implementation contributions from Cytel researchers. Fluvoxamine was found to significantly lower the number of COVID-19 patients admitted to the hospital by around 30 percent.

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While the findings have not been peer-reviewed, they are recently submitted to the US National Institutes of Health and the World Health Organization by Professor Edward Mills of McMaster University, Cytel's Principal Scientist and co-Principal Investigator of the TOGETHER Trial.

Speaking of the fluvoxamine results, Mills says, “This is a massive finding of benefit to public health. There is no other treatment for early COVID that has been shown to prevent the need for hospitalization.”

Mills has been committed to developing COVID-19 medicines that are widely and equitably accessible to all, especially those living in low- and middle-income countries since the outbreak began. Vaccines and many proposed cures are only available in wealthy countries, leaving less developed governments scurrying to protect their populations. Mills collaborates with a global network of health specialists to address this issue, and platform trials have been a critical component of this effort.

Platform studies, such as those used to evaluate fluvoxamine enable evaluating medicines using a single research design and a common control arm. This decreases costs and expedites the entire process of establishing efficacy by several years while also ensuring that more patients are enrolled in arms using newer medications. Although they are challenging to conduct, platform trials are excellent for use during public health emergencies when immediately identifying cost-effective novel medicines is a priority.

The TOGETHER Trial is evaluating the efficacy of well-known medicines in the treatment of COVID-19. Along with fluvoxamine, hydroxychloroquine, lopinavir/ritonavir, metformin, ivermectin, Peg-interferon-Lambda, and doxazosin have been used. Each medication is well-known in the medical world, has well-defined safety profiles for physicians to follow, is readily available, and is very inexpensive to manufacture. Before the promising findings concerning fluvoxamine were revealed, the trial excluded hydroxychloroquine, lopinavir/ritonavir, and metformin after early results failed to demonstrate a significant benefit. Ivermectin's initial testing revealed no beneficial effects; however, a second test using a different dosage is currently pending findings.

According to Dr. Kyle Wathen, VP of Scientific Strategy and Innovation at Cytel, “Platform trials are not only efficient at identifying therapies that work, but they also tend to quickly eliminate poorly performing therapies, making it a double win.”

Additionally, the TOGETHER TRIAL may pave the way for platform trials to become a more standard research study design. This milestone illustrates that, because of Cytels' contributions, this global health tool is now accessible to institutions and governments that previously lacked the means to conduct platform trials independently.

Cytel CEO Joshua Schultz says, “For thirty years, Cytel has been at the forefront of innovation in clinical research.  We are proud to have successfully designed and implemented a platform trial with the potential to help people around the world struggling with the lingering COVID-19 pandemic. We are hopeful that the TOGETHER Trial will continue to identify beneficial therapies and that the use of sophisticated approaches to designing and executing research studies will continue to expand.”

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