FDA lets NeuroRx, Relief Therapeutics test RLF-100 in Covid-19 patients

06 August 2020 - 10:01 By Reuters
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As part of NeuroRx’s enrollment in the Fast Track program, the FDA has requested NeuroRx to submit a publicly-available expanded access policy, so that physicians may request RLF-100 for their patients who are being treated in hospitals not participating in the ongoing Phase 2/3 clinical trials.
As part of NeuroRx’s enrollment in the Fast Track program, the FDA has requested NeuroRx to submit a publicly-available expanded access policy, so that physicians may request RLF-100 for their patients who are being treated in hospitals not participating in the ongoing Phase 2/3 clinical trials.
Image: 123RF/Wassana Sakulrattanapornchai

The U.S. Food and Drug Administration has granted NeuroRx Inc Investigational New Drug (IND) permission to test RLF-100 (aviptadil) for inhaled use in patients with moderate and severe Covid-19 to prevent progression to respiratory failure, it and partner Relief Therapeutics Holdings said on Thursday.

The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before Sept. 1, a joint statement said.

They said aviptadil is shown as the first Covid therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung.

It is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.

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