Drug candidate RFL-100 (aviptadil) may have two-fold benefit in patients with coronavirus 2019 (COVID-19).
Producing companies NeuroRx, Inc. and Relief Therapeutics announced this weekend results showing the antiviral Vasoactive Intestinal Polypeptide (VIP) therapy provided rapid respiratory failure reduction in most clinically ill patients with COVID-19—at a time when independent research also showed it blocked replication of SARS-CoV-2 in human lung cells and monocytes.
Further research of RLF-100, which is being developed as a Material Threat Medical Countermeasure in coordination with federal agencies including the National Institutes of Health (NIH), is planned to bolster these findings.
That said, it has already received Fast Track Designation from the US Food and Drug Administration (FDA).
A first report of rapid respiratory failure recovery under the therapy’s emergency use indication came from Houston Methodist Hospital, wherein a COVID-positive 54-year-old man being treated for rejection of a double lung transplant was able to come off ventilator-assisted breathing within 4 four days of care.
Similar benefits were reported in 15-plus other patients treated with RLF-100 under emergency use, according to NeuroRx and Relief, which indicates open access to the therapy for patients too ill to be admitted for the ongoing phase 2/3 clinical trial for patients.
X-ray results of patients with critical COVID-19 treated with RLF-100 also showed a quick clearing of classic pneumonitis findings on X-ray, as well as improved blood oxygen and a 50% or greater mean decrease in laboratory markers of COVID-19 inflammation.
Previous research from Brazilian investigators working in a level-4 biocontainment laboratory showed VIP is capable of inhibiting SARS-CoV-2 virus replication in human lung cells and monocytes. The South American team reported a case-control study showing patients who survived while on ventilators for COVID-19 had significantly greater VIP count in their blood than those who died from respiratory failure.
"No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," Professor Jonathan Javitt, chief executive officer and chairman of NeuroRx, said in a statement. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure.”
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