A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Intravenous MR11A8 in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome
Phase of Trial: Phase III
Latest Information Update: 16 Oct 2017
At a glance
- Drugs Interferon beta-1a (Primary)
- Indications Adult respiratory distress syndrome
- Focus Registrational; Therapeutic Use
- Sponsors Maruishi Pharmaceutical
- 06 Sep 2017 According to a Faron Pharmaceuticals media release, company anticipates completion of patient recruitment during H1 2018.
- 04 Sep 2017 According to a Faron Pharmaceuticals media release, the FDA has proposed that Faron can proceed directly to Biologics License Application (BLA) submission pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) with the Traumakine for the treatment of Acute Respiratory Distress Syndrome (ARDS).
- 29 Mar 2017 Status changed from not yet recruiting to recruiting, according to a Faron Pharmaceuticals media release.