On 25 September, Matinas BioPharma announced that it had begun pre-screening patients to determine eligibility for its upcoming Phase II ENHANCE-IT trial, which will be a pharmacodynamic (PD) assessment of its free fatty acid formulation omega-3, MAT9001, against Amarin’s Vascepa (icosapent ethyl) in patients with elevated triglycerides (150–499mg/dL).
MAT9001 is being developed for therapeutic applications in the dyslipidemia field and is targeting severe hypertriglyceridemia (TG >500mg/dL) as its primary indication. The trial will follow a previous head-to-head comparative pharmacokinetic (PK) and PD study, in which MAT9001 was shown to be superior against Vascepa in triglyceride, very-low-density lipoprotein (VLDL)-cholesterol, non-high density lipoprotein (HDL)-cholesterol, total cholesterol levels, and fasting triglycerides reductions.
GlobalData believes that with Matinas focusing its development efforts on further evaluation against Vascepa, the company has the potential to carve out a meaningful position in the omega-3 hypertriglyceridemia space.
Among differentiating features, MAT9001 is composed of a free fatty acid formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), while Vascepa is a high-purity formulation containing only icosapent ethyl, the ethyl ester of EPA. Due to its ethyl ester formulation, Vascepa’s absorption is augmented under very low-fat meal conditions.
However, MAT9001 could be absorbed without any significant food condition restrictions, which may prove more convenient and be preferred by patients. The upcoming head-to-head trial evaluating PK and PD markers in patients with elevated triglycerides under normal meal conditions should provide more clarity on this front.
Nonetheless, detailed efficacy, including potential adverse effects on lipid profiles, need to be further characterised to determine each drug’s position in the evolving omega-3 landscape.
ENHANCE-IT is on track to initiate in Q1 2020 with data expected in Q4 2020. This will be one of the several catalysts in the omega-3 space expected during 2019 and 2020. A highly anticipated advisory committee meeting relating to Amarin’s supplementary New Drug Application for expansion of Vascepa’s label, based on the REDUCE-IT cardiovascular outcomes study, is scheduled for 14 November, with the possibility of a US Prescription Drug User Fee Act priority review following in December.
GlobalData (2019). Heart Failure: Global Drug Forecast and Market Analysis to 2028, to be published