Matinas BioPharma Holdings Inc. (NYSEAMERICAN:MTNB) has announced the results of the End of the second phase meeting with the FDA regarding the development and registration pathway of its best in class omega-3 therapy MAT9001.
Results of the FDA meeting gives a clear pathway for Matina on MAT9001 development
According to the official minutes of the meeting, the company and the FDA are aligned on the next key steps for MAT9001’s third phase development programs and registration pathway for an indication f treating severe hypertriglyceridemia (SHTG). SHTG is a disorder related to complications like atherosclerotic cardiovascular disease and pancreatitis. Matinas is still on track to commence the third phase program in 1H 2021.
Chief Development Office of Matinas Theresa Matkovits stated that they were delighted with the FDA meeting’s positive outcome. She added that they are greatly encouraged by the strategic and collaborative input they received on the program. Matkovits said that they are pleased with what they have achieved as a team and were looking forward to commencing the third phase SHTG trial to optimize opportunities for MAT98001.
Matinas looking forward to NDA submission for MAT9001
The FDA and Matinas agreed on the third phase program’s main components supporting New Drug application filing that include a requirement for a 12-week single study supporting efficacy in SHTG. Interestingly, the agency offered some flexibility to the company in the totality of safety data required to meet the NDA requirements. Matinas assesses different ways to meet the needs and provides more data setting MAT9001 out from other omega-3 drugs.
Jerome Jabbour, the CEO of Matinas, said that the FDA’s alignment in the third phase development program offers a clear development pathway for MAT9001 in treating SHTG. He added that the agency’s important feedback gives the company confidence to move forward with a streamlined 505(b)2 registration for the therapy. Jerome said that they are looking forward to data from the current ENHANCE-IT data for MAT9001 relative to Vascepa to show the difference between the products and the possible criminal benefits of MAT9001.