Matinas BioPharma Holdings Inc. (NYSEAMERICAN:MTNB) has announced the End of Phase two meeting with the FDA regarding the registration pathway and development for MAT9001, a promising best-in-class Omega 3 prescription therapy.
Matinas to commence Phase 3 program in 1H 2021
According to the meeting’s official minutes, the company and the FDA have aligned on the nest steps in phase 3 MAT9001 development program and the enrolment pathway for an indication in the treatment of severe hypertriglyceridemia (SHTG). SHTG is a disorder that is related to major complications like atherosclerotic cardiovascular disease and pancreatitis. Matinas is on track to commence the third phase programs in 1H 2021.
Theresa Matkovits, the company’s Chief Development Officer, stated that they are excited about the outcome of the FDA meeting, and they are highly encouraged by the strategic and collaborative responses they received for the program. She indicated that they are proud of what they have achieved as a team and are looking forward to the commencement of Phase 3 study in SHTG to leverage clinical prospects for MAT9001.
Matinas BioPharma agreed with the FDA on the third phase program’s main aspects supporting the submission of the New Drug Application (NDA). This includes the requirement for the company to carry a single 12-week trail supporting SHTG’s efficacy. Most importantly, then FDA offered flexibility to the company in the totality of required safety data necessary for NDA submission.
Matinas BioPharma optimistic about MAT9001
Jerome D. Jabbour said that the company’s alignment with the FDA on the Phase 3 program offers clarity regarding MAT9001’s developmental pathway in SHTG. Jerome added that the regulatory agency’s positive feedback clears the way for the company to streamline its 505(b)2 MAT9001 registration.
He added that they are upbeat about the Omega-3 prescription therapy’s potential, and they are looking forward to the expected near-term data from the ENHANCE-IT MAT9001 trial against Vascepa. This study will show the differentiation between the therapies and the MAT9001’s clinical benefits for hypertriglyceridemia patients and those with cardiovascular disease.