MAT9001

Set to become the most effective omega-3 therapy.

Leveraging nearly 40 years of research in omega-3 therapy, we have developed MAT9001 – a proprietary prescription drug. It is comprised of a unique mix of potent omega-3 free fatty acids, most notably eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA). Throughout our development program, MAT9001 has demonstrated, among other benefits, absorption and triglyceride-lowering abilities that exceed those of existing omega-3 therapies. 

It is the only omega-3 pharmaceutical product specifically designed to treat dyslipidemia – conditions related to elevated lipids in the blood (cholesterol and triglycerides). The initial targeted indication for MAT9001 is in patients with triglycerides over 500mg/dl.

As elevated triglycerides, especially very high levels, can lead to deadly cardiac events like heart attacks and strokes, MAT9001 is positioned to become a foundational tool for improving heart health.

A clear difference.

MAT9001 incorporates highly differentiating mechanistic features, intended to overcome shortcomings of existing therapies in the omega-3 class. 

MAT9001

Comprised of a novel and highly potent combination of omega-3 free fatty acids. Our proprietary formulation contains a sizable dose of EPA, low amounts of docosahexaenoic acid (DHA), and the addition of a third important omega-3 fatty acid – DPA.

Existing Therapies

Contain mixtures of more readily available marine omega-3 fatty acids, including EPA, either alone or in combination with DHA. They generally include lower total amounts of omega-3s than MAT9001, rendering them potentially less effective as treatments.

MAT9001

Offers a particularly robust therapeutic profile, due to its delivery of increased blood levels of potent omega-3s, with additional beneficial biological effects.

Existing Therapies

While somewhat effective at reducing TGs and well-tolerated by patients, prior omega-3 products have shown less potency, less bioavailability, and less overall impact on lipids than MAT9001.

MAT9001

The only prescription omega-3 drug purposefully designed to treat dyslipidemia and help avert cardiovascular complications, with a composition that has been optimized for bioavailability and efficacy.

Existing Therapies

Originally designed for other applications beyond cardiovascular prevention. They were repurposed following clinical failures in other therapeutic areas and the incidental observation that they lowered TGs.

MAT9001

Demonstrates enhanced bioavailability as a free fatty acid formulation that has been optimized with a proprietary gelatin capsule technology, designed to improve tolerability and absorption.  

Existing Therapies

Comprised of ethyl esters, which are less bioavailable than free fatty acids and must be broken down in the digestive tract before they can be absorbed. Patients are thus required to take ethyl esters with a meal (which enhances this breakdown) – and ideally one higher in fat.

MAT9001

Comprised of a novel and highly potent combination of omega-3 free fatty acids. Our proprietary formulation contains a sizable dose of EPA, low amounts of docosahexaenoic acid (DHA), and the addition of a third important omega-3 fatty acid – DPA.

Existing Therapies

Contain mixtures of more readily available marine omega-3 fatty acids, including EPA, either alone or in combination with DHA. They generally include lower total amounts of omega-3s than MAT9001, rendering them potentially less effective as treatments.

MAT9001

Offers a particularly robust therapeutic profile, due to its delivery of increased blood levels of potent omega-3s, with additional beneficial biological effects.

Existing Therapies

While somewhat effective at reducing TGs and well-tolerated by patients, prior omega-3 products have shown less potency, less bioavailability, and less overall impact on lipids than MAT9001.

MAT9001

The only prescription omega-3 drug purposefully designed to treat dyslipidemia and help avert cardiovascular complications, with a composition that has been optimized for bioavailability and efficacy.

Existing Therapies

Originally designed for other applications beyond cardiovascular prevention. They were repurposed following clinical failures in other therapeutic areas and the incidental observation that they lowered TGs.

MAT9001

Demonstrates enhanced bioavailability as a free fatty acid formulation that has been optimized with a proprietary gelatin capsule technology, designed to improve tolerability and absorption.  

Existing Therapies

Comprised of ethyl esters, which are less bioavailable than free fatty acids and must be broken down in the digestive tract before they can be absorbed. Patients are thus required to take ethyl esters with a meal (which enhances this breakdown) – and ideally one higher in fat.

Recognizing the dangers of triglycerides.

Elevated triglycerides have been strongly linked to cardiovascular risk in multiple longitudinal studies. However, the notion that lowering triglycerides can potentially be a significant factor in reducing risk has only been acknowledged by the scientific community in the last decade or so.

Omega-3 fatty acids are a foundational part of the treatment of elevated triglycerides. As new studies emerge, it’s becoming increasingly clear that prescription omega-3s (unlike lower-dose, less pure supplements) are associated with meaningful clinical benefits. The higher the dose, the greater the potential benefit. High-dose omega-3s may also have beneficial effects beyond triglyceride reduction

About Omega-3s

Based on promising early data, Matinas filed an Investigational New Drug Application (IND) with the FDA in 2014.

The path to clinical success.

MAT9001 is currently in Phase 2 clinical development, but we have already completed one important study with compelling results, showing the drug to have greater bioavailability and potency than Vascepa®, one of the leading prescription omega-3 agents. We intend to further test and develop MAT9001 in a series of upcoming trials.

MAT9001

Hypertriglyceridemia

Pipeline

Completed Studies

Head-to-Head Study of MAT9001 (4g) vs. Vascepa® (4g)

Objective

A randomized, open-label, active-controlled, pharmacokinetic (PK)/pharmacodynamic (PD) trial of MAT9001 against marketing leading drug, Vascepa® (icosapent ethyl).

Overview

Study Population: 42 patients

Inclusion Criteria: Patients with triglyceride levels between 200-400 mg/dL (without lipid-altering Rx) and between 200-350 mg/dL (with stable–dose statin monoRx); men and women,18-70 years of age.

Trial Design: Patients were given a daily 4g dose of one drug 30 minutes after a meal. This occurred for the course of 14 days, with drug levels measured at days 1 and 14. Triglycerides and other blood lipid protein levels were measured throughout. After a 5-week washout period, patients returned to baseline and received the same treatment with the other drug for another 14 days.

Results

MAT9001 demonstrated superiority in lowering TGs, total- and non-HDL-cholesterol, VLDL cholesterol, apolipoproteins CIII and PCSK9 levels. It achieved a 33% reduction in triglycerides from the baseline, compared to Vascepa® at 10.5%. In these patients on a low-fat diet, MAT9001 was found to be six times more bioavailable than Vascepa®.

Median Changes


Median Changes Two

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Development Plan

Registration Studies

PK Bridging Study with Lovaza®:
As part of our regulatory program, in 2020, we have conducted a comparative crossover study to assess the bioavailability of MAT9001 and Lovaza® in 36 healthy volunteers. Patients were randomized to receive a single daily 4g dose of a study drug, have blood levels measured, undergo a 14-day wash-out period to return to baseline, be treated with a single dose of the other drug, and have final blood samples drawn.

Phase 3:
Pending discussions with the FDA, we plan to conduct at least one placebo controlled Phase 3 clinical study. The initial Phase 3 trial will assess the efficacy of MAT9001 in patients with severe  hypertriglyceridemia (TGs > 500 mg/dL). Approximately 390 patients will be treated over the course of 12 weeks.

Differentiation Studies

ENHANCE-IT:
In 2020, MAT9001 will also be evaluated in a second, confirmatory head-to-head pharmacodynamic trial versus Vascepa®. This crossover trial is similar to the previous study, but will involve 100 patients with elevated TGs (150-499 mg/dL), on a standard TLC diet, randomized and treated for 28 days with study drug, washed out for 28 days, and then treated for another 28 days with the other drug. The primary endpoint will be the percent of TG reduction compared to baseline for that treatment period, and additional blood levels of Omega-3s will be obtained. We expect this study will confirm the previously observed superiority of MAT9001.