Amarex executes five rush COVID-19-related submissions to FDA

3 April 2020

In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab.

The product is currently being tested for HIV infection, and oncology indications, and has the potential to modulate the “cytokine storm” sometimes seen in COVID-19 patients. A “cytokine storm” is an overproduction of immune cells and their activating compounds, which can contribute to life-threatening respiratory distress.

CytoDyn received rapid approval from the FDA for the emergency treatment of extremely ill COVID-19 patients. On 27 March, CytoDyn released initial positive results in the first four patients treated, having seen a reduction of the hyper-immune response three days following treatment initiation.

As of 1 April, CytoDyn reported that a total of 10 patients have received treatment under emergency use. On 30 March, FDA cleared a second IND for a Phase II randomised trial to treat mildly to moderately ill coronavirus patients with Leronlimab, with enrollment to begin immediately. Amarex is currently managing the trial. On 1 April, CytoDyn reported that it filed an IND amendment with the FDA for a protocol to treat severely ill COVID-19 patients with Leronlimab where the primary endpoint is mortality rate at two weeks. Amarex also prepared this submission.

On 25 March, Amarex also executed a rush submission to the US FDA for a Compassionate Use Approval (CUA) for treatment of COVID-19 patients with a device that is currently in testing under an existing Investigational Device Exemption (IDE) for a different medical condition. Based on the mechanism of action there is reason to believe that the device may be an effective treatment for COVID-19 patients displaying serious symptoms. Amarex prepared the submission in a matter of days, which included writing a new clinical trial protocol; the typical submission process can take five weeks or more.

On 27 March, Amarex executed a rush submission to the US FDA of an Emergency Use Authorisation (EUA) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea, and Amarex and its client are therefore hopeful for a rapid FDA approval result.

“I count myself lucky to work with our Amarex team,” said Amarex president and CEO Dr. Kazem Kazempour. “They’re incredibly caring, dedicated people as well as skilled experts who have been quick to adapt to this rapidly-changing situation.”



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