NRx Pharmaceuticals has reported that a US National Institutes of Health (NIH) trial analysing Zyesami (aviptadil) to treat critical Covid-19 patients will progress to conclude full subject enrolment.
The latest move to continue the trial comes after the Therapeutics and Prevention Data Safety and Monitoring Board (DSMB) of the NIH unit National Institute of Allergy and Infectious Diseases (NIAID) carried out an assessment of data from the trial.
The DSMB analysed data obtained from 448 subjects admitted to the ICU with respiratory failure due to critical Covid-19 in the ACTIV-3b (TESICO) trial.
No new safety concerns were found and the DSMB recommended progressing subject enrolment to 640 patients.
Subjects in TESICO are critically-ill ICU patients who have exhausted all other approved treatments and need high-flow nasal oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
NRx noted that the NIH filed and obtained clearance from the US Food and Drug Administration (FDA) for the TESICO protocol as a Phase III trial.
On obtaining positive data from the trial, it could be utilised for submitting a New Drug Application for Zyesami.
The randomised, placebo-controlled ACTIV-3b trial is analysing Zyesami and Gilead Sciences’ Veklury (remdesivir), as a single agent or in combination, in Covid-19 patients admitted to the hospital with acute respiratory failure.
The ACTIV-3b trial enrolled 448 subjects with critical Covid-19 and will be expanded to Brazil, the European Union, the UK and Scandinavia soon.
NRx Pharmaceuticals chairman and CEO professor Jonathan Javitt said: “With more than 80% of the trial enrolled, we are highly encouraged that the Data Safety and Monitoring Board has continued enrolment and that trial investigators have continued to express enthusiasm for enrolling patients into the Zyesami arm of the trial at some of the nation’s most advanced hospitals.
“So far, we have received no reports of drug-related Serious Adverse Events in Zyesami-treated patients and are sharing those data with the FDA.”
In January this year, NRx submitted an application seeking Emergency Use Authorization from the US Food and Drug Administration (FDA) for Zyesami for critical Covid-19 treatment.