A Phase 3 Registration Trial of MAT9001 in Patients with Severe Hypertriglyceridemia
Latest Information Update: 31 Mar 2020
At a glance
- Drugs Ethyl eicosapentaenoic acid (Primary)
- Indications Hypertriglyceridaemia
- Focus Registrational; Therapeutic Use
- Sponsors Matinas BioPharma
- 31 Mar 2020 According to a Matinas BioPharma media release, the company's ongoing preparations for an End-of-Phase 2 meeting for MAT9001 with the FDA to date have not been impacted by the COVID-19 pandemic. Those studies necessary to support a planned 505(b)(2) registration pathway have been completed and final study reports are in the process of being prepared.
- 09 Mar 2020 According to a Matinas BioPharma media release, the company has completed the clinical dosing for a comparative clinical bridging bioavailability study and the in-life portion of a 90-day comparative toxicology study in the 1Q2020. Each of these studies was conducted in support of a planned 505(b)(2) registration pathwayThe Company anticipates holding an End-of-Phase 2 meeting with the U.S. FDA in the 3Q2020 to discuss these data as well as the protocol for this study.
- 29 Nov 2013 New trial record