LYPDISO™ (MAT9001)
Set to become the most effective omega-3 therapy.
Leveraging nearly 40 years of research in omega-3 therapy, we have developed LYPDISO – 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, LYPDISO 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 LYPDISO 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, LYPDISO is positioned to become a foundational tool for improving heart health.
A clear difference.
LYPDISO incorporates highly differentiating mechanistic features, intended to overcome shortcomings of existing therapies in the omega-3 class.
Unique Formulation
UNIQUE FORMULATION
High Potency
HIGH POTENCY
Specially Engineered
SPECIALLY ENGINEERED
Enhanced Absorption
ENHANCED ABSORPTION
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
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
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.
Matinas BioPharma Holdings, Inc.
SCIENCE
LNC PLATFORM
MAT2203
MAT2501
LYPDISO™ (MAT9001)
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