New Drug for COVID-19 Treatment is Developed in St. Louis with Clinical Trial in Kansas

    By Kathleen Berger, Executive Producer for Science and Technology

    A novel drug developed in St. Louis for the treatment of rheumatoid arthritis is being investigated as a possible treatment for COVID-19.

    Joseph Monahan, PhD, is the executive vice president of research and development for Confluence Discovery Technologies, an Aclaris Therapeutics company.

    “We did a lot of preclinical work in cells and animals to make sure this drug did work, particularly as an anti-inflammatory drug,” said Monahan. “We first put it into people, volunteers, in 2019.”

    The first human clinical trial involving rheumatoid arthritis patients successfully tested the safety and efficacy of ATI-450. The anti-inflammatory drug is informally named after the company with the assigned number until a formal name is chosen.

    In 2020, ATI-450 will be used in a larger clinical for patients with rheumatoid arthritis.

    The research and development arm of Aclaris Therapeutics operates out of the BioGenerator Labs space, as a BioSTL partner. Its labs are in the Cortex Innovation Community of St. Louis, which is known as one of the fastest growing biotechnology districts in the country.

    Aclaris Therapeutics, Inc., a clinical-stage biopharmaceutical company, is developing a pipeline of novel drug candidates for immunoinflammatory diseases. The FDA has allowed the company’s investigational new drug application to evaluate ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.

    Aclaris is supporting an investigator-initiated trial of ATI-450 in 36 hospitalized patients with COVID-19, and will provide funding and the clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial located in Kansas City, Kansas.

    The clinical trial is underway to treat patients with the novel coronavirus because COVID-19 can cause acute respiratory distress syndrome, ARDS.

    “Literature that’s come out over the last four or five months suggests one of the causes of ARDS is a hyperactive immune response, so the immune system is triggered when you get the viral infection, but for some reason the immune system goes a little haywire and this results in an inflammatory state,” explained Monahan. “The data suggests that this inflammatory state, this hyperinflammation, is associated with an upregulation of certain proteins that come from both diseased tissue and immune cells, called cytokines. And these cytokines could be the culprit in driving this ARDS and the inflammation seen in the lung in COVID-19 patients.”

    Monahan explained the reason it’s believed ATI-450 will work as a rheumatoid arthritis treatment is because the drug downregulates cytokines, inhibiting their production.

    “Many of the same cytokines involved in the inflammation of an arthritic joint are also involved in the inflammation in the lung of a COVID patient,” said Monahan. “We had that preclinical data that suggested that we could block a number of these cytokines. And in blocking these cytokines, the hypothesis would be that we would stop the progression of the infection, we would stop the hyperinflammation and we would stop the progression of ARDS in these patients.”

    Success with the placebo-controlled study involving 36 patients at the University of Kansas Medical Center would lead to a large-scale clinical trial enrolling hundreds of patients.

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