Editor’s note: This story is taken from a Louisiana State University (LSU) press release.
Skymount Medical has partnered with Riverside University Health System (RUHS) Medical Center to hold the first U.S. clinical trial on the efficacy of COVID-19 oral therapeutics LSU researchers discovered using artificial intelligence (AI). The testing will be conducted through RUHS Medical Center’s Comparative Effectiveness and Clinical Outcomes Research Center (CECORC) in Moreno Valley.
It will evaluate the combined effects of an already Federal Drug Administration (FDA)-approved cancer medication and an already FDA-approved anti-parasitic agent used on human adults and children in patients with mild to moderate COVID-19 symptoms who do not need hospitalization.
Similar studies are already underway in Europe. Although the outcomes for patients have yet to be revealed, predictive studies leveraged by LSU’s AI technology and early cell and animal studies conducted by Illinois Institute of Technology have already shown the new drug combination up to 97% effective in reducing the amount of SARS-CoV-2, the virus that causes COVID-19.
“We’re excited to partner with RUHS and Dr. Bruce Weng’s team to facilitate a human clinical investigation to try to demonstrate the safety of the drug combination and efficacy in adult patients who have tested positive for COVID-19 and exhibit mild to moderate symptoms,” said Dr. Kishor Wasan, Skymount Medical’s chief medical and scientific officer, Distinguished University Scholar adjunct professor in the Faculty of Medicine at the University of British Columbia and co-inventor of the therapeutic combination.
The study will be a double-blind intervention conducted in an outpatient setting, comparing the two-drug combination to a placebo. The goal of the study is to determine the impact this combination therapy will have on decreasing the length and severity of symptoms without negative side effects. The study also will evaluate if the combination drug can help decrease the need for hospitalizations.
Weng, an infectious disease physician at RUHS Medical Center, will inform patients diagnosed with COVID-19 about the study, and invite them to participate. Patients will be screened, enrolled and have subsequent follow up visits in the RUHS Emergency Department.
“Unfortunately, California has its fair share of COVID-19 cases,” Weng said. “The one silver lining in this is that the sample size at our hospital is substantial enough to produce valuable data when evaluating the safety and efficacy of this drug combination. This is a pilot study and 100% voluntary. The safety of our patients is paramount, and we will stay in constant contact with those choosing to participate to ensure their health and well-being.”
The researchers are hopeful the new therapeutic also will prevent lingering symptoms, which some people experience following COVID-19.
“The drug combination may reduce long-haul syndrome, the long-term consequences some patients report even after recovering from COVID-19, such as mental health issues and damage to organs,” Wasan said.
DeepDrug™, the AI platform that helped discover the oral therapeutic, was created by an interdisciplinary team of LSU researchers led by Dr. Supratik Mukhopadhyay, associate professor in the LSU Department of Computer Science. DeepDrug™ uses a next-generation AI capability that reduces the time and cost of drug discovery by up to 90%.
“It’s very gratifying to see this medication enter into the human study phase,” Mukhopadhyay said. “The fact that we are at this stage so quickly is due to Skymount Medical’s vast professional medical network and our DeepDrug™ platform, which was able to identify this particular combination of medications in a fraction of the time that traditional research takes.”
If Skymount Medical’s oral therapeutic for COVID-19 receives final approval, the company intends to make the treatment widely available and cost-effective.