NeuroRx, Relief Therapeutics have announced initial successful results from expanded access use of RLF-100 (aviptadil) in patients suffering with critical Covid-19 and severe comobordities, with 72% of them admitted into ICU surviving.
RLF-100 is a formulation of Vasoactive Intestinal Polypeptide (VIP), which is present in high concentrations in the lungs and is known to block various inflammatory cytokines.
The companies said that more than 175 such patients have now entered into an Expanded Access Protocol (EAP) with RLF-100 in the US.
All of them had severe comorbidities such as organ transplant, recent heart attack, and cancer that made them ineligible for the ongoing Phase IIb/III trial.
This randomised, controlled trial is evaluating the safety and efficacy of RLF-100.
These patients were deteriorating even after providing approved therapies for Covid-19.
Data showed that of the 90 patients who have so far reached 28 days of follow-up, 72% survived to day 28.
Twenty-one patients who received RLF-100 under the EAP were compared to 24 patients in the control group treated in the same setting at the Houston Methodist Hospital.
Data showed that only 17% of these control patients even after providing the best available intensive care unit (ICU) Standard of Care, survived to day 28.
According to the companies, the survival rate with RLF-100 was comparable to that seen by the hospital among the open-label patients treated with RLF-100.
In the EAP, so far, no drug-related Serious Adverse Events were recorded among these patients or those in the ongoing phase IIb/III trial in the US involving 160 patients.
NeuroRx CEO and founder Prof Jonathan Javitt said: “We are reassured that emerging real-world data on the use of RLF-100 in improving survival in patients with critical Covid-19 are comparable to results seen in the hands of major academic teaching centres.
“We look forward to completing enrolment and reporting the results of our pivotal US clinical trial.”
Earlier this month, NeuroRx and Relief announced that the independent Data Monitoring Committee voted for the continuation of the Phase IIb/III trial of RLF-100 to treat respiratory failure in critically ill patients with Covid-19.