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A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial
A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial
Status:Planning
Phase of Trial:
Phase III
Latest Information Update:04 Jan 2021
Price :
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At a glance
Drugs
Ethyl eicosapentaenoic acid (Primary)
Indications
Hypertriglyceridaemia
Focus
Registrational; Therapeutic Use
Acronyms
AMPLIFY
Sponsors
Matinas BioPharma
Most Recent Events
04 Jan 2021
According to Matinas BioPharma media release, the company expect to initiate this study in the second half of 2021.
15 Sep 2020
According to Matinas BioPharma media release, the company is evaluating several ways to both meet these requirements and to potentially provide additional data differentiating MAT9001 from other prescription omega-3 drugs.
15 Sep 2020
According to Matinas BioPharma media release, the company and FDA The Company and the FDA agreed on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including the requirement for a single 12-week study to support efficacy in SHTG and FDA provided flexibility to Matinas in the totality of patient safety data needed to meet regulatory requirements for NDA submission.
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