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LYPDISO™ Overview

A clear difference.

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

LYPDISO

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 LYPDISO, rendering them potentially less effective as treatments.

LYPDISO

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 LYPDISO.

LYPDISO

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.

LYPDISO

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.

LYPDISO

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 LYPDISO, rendering them potentially less effective as treatments.

LYPDISO

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 LYPDISO.

LYPDISO

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.

LYPDISO

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.

LYPDISO 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 LYPDISO in a series of upcoming trials.

LYPDISO

Hypertriglyceridemia

Pipeline

Completed Studies

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

Objective

A randomized, open-label, active-controlled, pharmacokinetic (PK)/pharmacodynamic (PD) trial of LYPDISO 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

LYPDISO 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, LYPDISO 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 LYPDISO 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 LYPDISO 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, LYPDISO 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 LYPDISO.