-- MHRA grants permission for UK clinical trials for AI-discovered drug combination that reduces length and severity of symptoms and could lower hospitalizations --
-- Approval expands Skymount Medical's global reach --
CALGARY, Alberta and BATON ROGUE, La., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Skymount Medical, a drug discovery company using an artificial intelligence (AI) platform developed by Louisiana State University (LSU) researchers to repurpose and build new drugs, announced today that it has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a human clinical trial of its novel oral therapeutic for patients with mild to moderate COVID-19. The study will be a double-blind intervention comparing a two-drug combination and a single antiviral drug to a placebo. It will determine the impact these therapies will have on the length and severity of COVID-19 symptoms.
The two-drug combination was discovered using the DeepDrugTM AI platform and is comprised of a cancer medication already approved by the United States Food and Drug Administration (FDA) and an FDA-approved anti-parasitic agent. Designed to address both the viral load and the inflammatory aspects of COVID-19, the treatment has shown up to 97% efficacy in reducing the amount of SARS-CoV-2 in cell and animal studies, without negative side effects.
"This is a significant milestone for Skymount Medical, the LSU DeepDrugTM AI platform, and patients suffering from mild to moderate COVID-19. There are currently limited approved oral medication options to alleviate COVID-19 symptoms in adult patients who are not hospitalized, and the drug combination or single drug would be administered at the first sign of infection, reducing the amount and duration of symptoms, and allowing patients to avoid hospitalization," said Dr. Kishor Wasan, PLC (Harvard Kennedy School), R.PH., PH.D., FAAPS, FCAHS, FCSPS, Chief Medical and Scientific Officer of Skymount Medical & Distinguished University Scholar Adjunct Professor at the University of British Columbia. "With our drug combination already in a human pilot study in the United States, we are pleased to expand the reach of this combination therapy internationally."
"Receiving MHRA approval for UK clinical trials is very exciting," said Dr. Supratik Mukhopadhyay, DeepDrugTM team leader and professor in the LSU Department of Environmental Sciences. "Getting to this point this quickly demonstrates the power of AI and our DeepDrugTM platform. Our AI was trained to recognize similarities between existing drugs and antiviral peptides, which target coronaviruses, and was then tested on unseen pairs where it achieved an accuracy of 97.28%-unrelated to the efficacy of the drugs themselves. Next, we asked the AI to predict which FDA-approved drugs could act in a similar way, and found several good candidates, with one of the most promising combinations now entering human trials in the UK."
As a next step prior to initiating the clinical study, Skymount Medical will obtain the appropriate UK Ethics Committee approval and identify suitable clinical sites. It is expected that 150 patients will participate in the UK study.
About DeepDrug
The DeepDrug artificial intelligence platform was developed by an interdisciplinary team of Louisiana State University (LSU) researchers led by Dr. Supratik Mukhopadhyay, professor in the LSU Department of Environmental Sciences, and Dr. Michal Brylinski, associate professor in the LSU Department of Biological Sciences with a joint appointment in the LSU Center for Computation & Technology. The DeepDrug platform uses several key components to deliver a state-of-the-art compound and formula generation capability that greatly reduces the time and cost associated with traditional drug discovery.
About Skymount Medical
Skymount Medical is a technology company that uses DeepDrug?, a patent-pending artificial intelligence platform, to drastically reduce drug discovery time. Alongside Louisiana State University, the company is currently developing combination therapies to fight COVID-19 and all coronavirus strains, including SARS, MERS, SARS-CoV-2 and future SARS-CoV variants. In addition, Skymount Medical is planning to develop therapeutics for other infectious diseases as well as new antibiotics that target antibiotic-resistant bacteria and rare diseases, such as amyotrophic lateral sclerosisto learn more.
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