Therapy Areas: Inflammatory Diseases
NeuroRx and Relief Conclude Enrollment in their Phase 2b/3 Trial of RLF-100 for Critical COVID-19 with Respiratory Failure
30 December 2020 - - US-based NeuroRx, Inc. and Switzerland-based Relief Therapeutics Holding AG (SIX: RLF) (OTCQB: RLFTF) have concluded enrollment in the phase 2b/3 trial of Zyesami (previously RLF-100: aviptadil) for the treatment of Respiratory Failure in patients with Critical COVID-19, the companies said.

No drug-related serious adverse events have been reported as of TODAY. Enrollment was increased from 165 patients in order to amass as large a safety database as possible.

Top line data are expected in late January - early February 2021.

Vasoactive Intestinal Polypeptide was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs.

VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation.

Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type II cell, that is critical to transmission of oxygen to the body.

COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. They are vulnerable because of their surface receptors, which serve as the route of entry for the virus.

These specialized cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Loss of surfactant causes collapse of the air sacs (alveolae) in the lung and results in respiratory failure.

VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production.

Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable Type II cells.

Zyesami (RLF-100TM: Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide that was developed based on Prof. Sami Said's original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001.

VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant.

FDA has now granted IND authorization for intravenous and inhaled delivery of aviptadil for the treatment of COVID-19 and awarded Fast Track designation.

Zyesami is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19.

Since July 2020, more than 300 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100 between the two FDA-cleared protocols (randomized and expanded access).