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A Phase 3 Registration Trial of MAT9001 in Patients with Severe Hypertriglyceridemia
A Phase 3 Registration Trial of MAT9001 in Patients with Severe Hypertriglyceridemia
Status:Planning
Phase of Trial:
Phase III
Latest Information Update:31 Mar 2020
Price :
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At a glance
Drugs
Ethyl eicosapentaenoic acid (Primary)
Indications
Hypertriglyceridaemia
Focus
Registrational; Therapeutic Use
Sponsors
Matinas BioPharma
Most Recent Events
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
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