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A Comparative Clinical Bridging Bioavailability Study of MAT9001

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Trial Profile

A Comparative Clinical Bridging Bioavailability Study of MAT9001

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2020

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At a glance

  • Drugs Ethyl eicosapentaenoic acid (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Matinas BioPharma

Most Recent Events

  • 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.
  • 15 Sep 2020 According to Matinas BioPharma media release, the company announced the positive results from the End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and onfirmed that the FDA and Matinas are aligned on key next steps for MAT9001's Phase 3 development program and registration pathway for an initial indication to treat severe hypertriglyceridemia (SHTG).

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