- In the US, RLF-100 has been granted fast track designation by FDA for treatment of respiratory distress in COVID-19
Critically ill covid 19 patients recovered rapidly from respiratory distress after treatment with RLF-100, two drug companies said. In the US, RLF-100 has been granted fast track designation by FDA for treatment of respiratory distress in COVID-19.
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 US.
“Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) was seen in patients with severe medical comorbidities after three days of treatment with RLF-100 under FDA Emergency Use IND authorization at multiple clinical sites,” the companies said, adding that Aviptadil is being developed as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes.
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 IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial,” it said.
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.
“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” said Prof. Jonathan Javitt, CEO 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 these data later this month.”
Courtesy LiveMint
