Matinas BioPharma Inc. (OTCQB: MTNB) focuses on the development of prescription medications for the treatment of cardiovascular and metabolic diseases.
1. Please explain the differentiating factors of your scientific approach.
Fats or fatty acids are not just a source of energy, they are also a source for important signaling molecules or are signaling/regulatory molecules unto themselves. Nature has created more than hundred different fatty acids and each of these fatty acids has their own unique function. Some fatty acids are very abundant (such as palmitate, stearate or oleate), while other fatty acids are very rare.
Matinas BioPharma (MTNB) has developed a unique capability to manufacture and isolate rare omega-3 fatty acids, such as DocosaPentaenoic Acid (DPA), and obtain them in pure form. Such rare omega-3 fatty acids are very hard to isolate at any meaningful commercial scale from natural sources. These rare omega-3 fatty acids have unique functionalities and allow the Company to develop products that go beyond simple fish-oil extracts. With this capability, MTNB has engaged in the development of highly differentiating omega-3 compositions for the treatment of cardiovascular/metabolic diseases.
Our capability to manufacture and isolate rare omega-3 fatty acids distinguishes us from other companies in the dyslipidemia and metabolic disease space, and we believe unique capability provides us with a sustainable competitive advantage.
2. Who are the developers of your technology?
The MTNB team has a significant track record of developing and commercializing cardiovascular and dyslipidemia medications. We gained much of our dyslipidemia experience at Reliant Pharmaceuticals, where we developed/launched Lescol XL (a statin), Antara (a fenofibrate formulation), and Lovaza (an omega-3 fatty acid composition and first-ever approved prescription omega-3). Following its launch in late 2005, Lovaza saw significant prescription growth and in 2007 GlaxoSmithKline acquired Reliant for $1.65 billion. Lovaza continued to rise to blockbuster status with peak sales over $1 billion/year.
The technology to manufacture and isolate rare omega-3 fatty acids was developed in-house by the founding members of the MTNB team (¾ of us are scientists). We recognized early on that this approach would likely provide us with significant differentiation and therefore focused, in close collaboration with a few select third parties, on manufacturing DPA on a scale that is supportive of pre-clinical and clinical development. Our data with DPA (see the “Our Science” page on www.matinasbiopharma.com) are indicative of a differentiating therapeutic profile.
3. What made the company choose to develop the next generation of omega-3-fatty-acid-based-phamaceutical products?
The clinical need in the cardiovascular/metabolic disease remains high and growing due to the growing obesity epidemic and increasing human life-span (both in the US and globally). High cholesterol and triglyceride levels remain at concerning levels (about 65 million US adults have above normal triglyceride levels and about 30 million have a form of fatty liver disease). While statins have reduced the risk of cardiovascular events in high risk individuals by more than 25%, because of the growing obesity/lifestyle problem a significant adverse cardiovascular event rate remains and causes a need to further treat dyslipidemic and metabolic conditions. Our lead product MAT9001 is in development for dyslipidemia (severe hypertriglyceridemia as primary indication; TG≥500 mg/dL) and the MAT8800 discovery program is aiming to identify promising product candidates for the treatment of fatty liver disease.
4. What is the size of this market both in both patients and healthcare costs?
In the US, about 65 million adults have above normal triglycerides and about 4 million adults have severe hypertriglyceridemia or Very High TriGlycerides (VHTG: TG≥500 mg/dL. Worldwide, more than 20 million patients have VHTG. At the Lovaza/Vascepa price level of about $2,000 annually, the US VHTG market potential is about $8 billion. This is the indication we have targeted initially. A market share of 3%-4% would already result in $250-$300 million annual revenues.
About 30 million US adults have fatty liver disease, a condition that may lead to cirrhosis and liver failure and for which no pharmaceutical treatment has been approved to date.
5. What specific products are currently in development?
We are developing MAT9001 for dyslipidemia and cardiovascular disease, with severe hypertriglyceridemia or VHTG as primary indication. We also have initiated a discovery program in fatty liver disease (MAT8800).
6. At what stage of development are the products?
We are currently preparing the MAT9001 IND for filing with the FDA and also expect to initiate our first human study in the fourth quarter of 2014 with results within half a year of commencement. We aim to commence Phase 3 for MAT9001 during the first half of 2015, with results expected in late 2016. MAT8800 is in the preclinical stage and we should identify a candidate for clinical development during 2015.
7. Where is the company regarding FDA clinical trials?
One of the key challenges in pharmaceutical development is the significant time requirement for development and approval of new medications, which sometimes requires up to a decade of investment and research. Our goal is to minimize development time and therefore Matinas BioPharma is pursuing a 505(b)(2) NDA development strategy, which typically results in a much shorter development timeline. Our goal is to start the Phase 3 clinical trial for severe hypertriglyceridemia during the first half of 2015 with the key data from this trial and NDA submission expected in late 2016 and FDA approval in late 2017.
8. How do you compare to both current treatments and other potential new treatments for cardiovascular and metabolic diseases?
We have yet to generate clinical data for MAT9001. In our animal studies, DPA, the key differentiating component of MAT9001, demonstrated to be a very potent reducer of fasting triglycerides and down-regulated the mRNA expression for the HMG-CoA-reductase and PCSK9 genes in conjunction with statin treatment, indicating the potential for significant beneficial cholesterol effects. We believe MAT9001 will be the most potent medication for the treatment of patients with elevated triglycerides while also demonstrating unique effects on cholesterol.
© 2017 Stock News Now
Supported by Superior Web Solutions