By Tova Cohen; Reuters
TEL AVIV (Reuters) – Critically ill COVID-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said on Sunday.
Geneva-based Relief Therapeutics Holdings AG RFLB.S has a patent for RLF-100, or aviptadil, a synthetic form of a natural peptide that protects the lung. U.S.-Israeli NeuroRx Inc partnered with Relief to develop the drug in the United States.
In June the U.S. Food and Drug Administration granted fast-track designation to RLF-100 for treatment of respiratory distress in COVID-19.
While a Phase 2/3 clinical trial with 70 patients is ongoing, RLF-100 is being administered on an emergency basis to some patients who are too ill to be admitted to the trial.
The first report of rapid recovery under emergency use was posted by doctors from Houston Methodist Hospital, the companies said in a joint statement.
It said a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant came off a ventilator within four days of treatment with RLF-100.
Similar results were subsequently seen in more than 15
patients treated under emergency use, the companies said.
The two companies also said independent researchers in a biocontainment laboratory in Brazil reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and immune cells.
“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” NeuroRx CEO Jonathan Javitt said.
The clinical trials are looking at whether similar observations will be confirmed for less ill patients with COVID-19-related respiratory failure.
An independent data monitoring committee will be conducting an interim analysis of these data later this month, Javitt told Reuters.