Matinas BioPharma Holdings Inc (NYSEAMERICAN:MTNB) announced Tuesday a positive result of its End of Phase 2 meeting with the US Food and Drug Administration (FDA) on the development and registration pathway for MAT9001, a potential best-in-class prescription omega-3 therapy.
The company said the official minutes of the meeting confirmed that it and the FDA 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), a clinical disorder associated with major complications such as pancreatitis and atherosclerotic cardiovascular disease.
Matinas, based in Bedminster, New Jersey, said it remains on track to initiate its Phase 3 program in the first half of 2021.
“We are extremely pleased with the outcome of our meeting with FDA and are encouraged by the highly collaborative and strategic input we received for our program,” said Theresa Matkovits, Matinas’ chief development officer, in a statement.
“I am very proud of what we have accomplished as a team and look forward to initiating the Phase 3 trial in SHTG and maximize the clinical opportunities for MAT9001.”
The company said it 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.
Moreover, Matinas said the FDA provided it flexibility in the totality of patient safety data needed to meet regulatory requirements for NDA submission. 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.
“Alignment with the FDA on our Phase 3 development program provides clarity about our development pathway for MAT9001 in SHTG,” said Matinas CEO Jerome Jabbour.
“With this important feedback from FDA, we can confidently move forward with our streamlined 505(b)2 registration for MAT9001. Our level of enthusiasm for this potential best-in-class omega-3 therapy remains high, and we look forward to forthcoming near-term data from our ongoing ENHANCE-IT head to head trial of MAT9001 vs. Vascepa to once again highlight the differentiation between these two products and the potential significant clinical benefits of MAT9001 for patients with hypertriglyceridemia and cardiovascular disease.”
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