NeuroRx and Relief Therapeutics have announced that their investigational therapeutic RLF-100 produces rapid recovery from respiratory failure in critically-ill COVID-19 patients.
Currently, RLF-100 (aviptadil) is being tested in an ongoing phase 2/3 trial and is also being administered to patients on an emergency use basis.
The first report of rapid clinical recovery was observed by doctors from Houston Methodist Hospital in the US, after a 54-year-old man was given the treatment via the emergency use scheme.
According to the report, the patient had tested positive for COVID-19 while being treated for rejection of a double lung transplant. After treatment with RLF-100, the patient was able to come off a ventilator within four days.
NeuroRx and Relief have said that similar results were also observed in more than 15 patients treated on an emergency use basis and as part of the US Food and Drug Administration (FDA) expanded access protocol. This includes patients who are deemed too ill to be admitted to the ongoing phase 2/3 FDA trial.
Among these initial findings, patients treated with the experimental drug were seen to have a rapid clearing of classic pneumonitis findings on x-ray, as well as an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.
RLF-100 is a formulation of vasoactive intestinal polypeptide (VIP), which is known to be highly concentrated in the lungs and thought to inhibit a number of inflammatory cytokines.
VIP has been shown in over 100 peer-reviewed studies to have significant anti-inflammatory activity in animal models of respiratory distress, acute lung injury and inflammation.
COVID-related death is often linked to an over-active inflammatory response, known as cytokine storm, which causes the body’s reaction to the infection to go into overdrive. This hyper inflammation can seriously harm and cause death in patients with COVID-19.
“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” said Jonathan Javitt, chief executive officer and chairman of NeuroRx.
“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. Our independent data monitoring committee will be conducting an interim analysis of this data later this month,” he added.