Home https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Health https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Matinas rides Amarin coat as Vascepa wins FDA voting panel

Matinas rides Amarin coat as Vascepa wins FDA voting panel

Amarin (NASDAQ: AMRN) is not the only company to celebrate Vaseppa's victory with the FDA Advisory Committee last week. Matinas BioPharma (MTNB) also drives the Vaseppa wave. In fact, in the last month the two stocks have been moving almost equally. If the FDA decides to follow the advice on its panel and approve Vascepa for using statins to reduce the risk of cardiovascular events, Matinas may continue to fuck higher with Amarin. That's why.

Vascepa is a prescription-only omega-3 fatty acid (EPA) medicine, proven last year in a successful Phase III cardiovascular test that it can reduce the risk of cardiovascular events by 25% in addition to statins. The only question was whether the placebo with the mineral oil used in this trial inadvertently impeded the absorption of statins, which could distort the results in favor of the Vascepa arm. The FDA itself had decided that the evidence was inconclusive and therefore the committee did not hesitate to recommend Vascepa as an additional statin therapy in these patients.

Now let's rewrite 4 years. In 2015, Matinas conducted a phase I trial of its own omega 3 MAT9001 drug, comparing it directly with Vascepa. The trial had an unusual setting, with only 42 people enrolled, but the trial was actually powered, as if double that number being tested. First, all 42 were randomly assigned to receive MAT9001 or Vascepa, 4 capsules per day for 14 days. This is followed by a 5-week washout period and then the medication is changed in all persons.

There are three test data that are worth mentioning specifically. First, MAT9001 was much more effective than Vascepa in reducing triglycerides and VLDL-C. MAT9001 observed a decrease of 33.2% from baseline compared to 10.5% for Vascepa and the VLDL-C decrease of 32.5% against 8.1% for Vascepa. Second, MAT9001 managed to reduce PCSK9 levels by 12.3%, while Vascepa showed PCSK9 levels actually increase by 8.8%.

The significance of the latter point is that PCSK9 is a target for cholesterol drugs such as Regeneron (REGN) Praluent and Amgen (AMGN)) turnips, so reducing this number can be particularly significant. Third, the amount of active drug with omega 3 fatty acids measured in blood plasma is about 6.5 times higher for MAT9001 than for Vascepa.

Despite the success of this test, Matinas placed MAT9001 on his back while using his resources to develop his lead antifungal candidate. Since then, the company has revived MAT9001, and a 100-patient Phase II crossover trial (re-energized as if 200 were enrolled) against high triglyceride patients on Vascepa will begin dosing in the next quarter, with results expected by the end of 2020.

Nothing of this, of course, does not prove that MAT9001 will succeed and in the end, what is important is stocks. Still, the interesting thing is that Amarin has already embarked on this rocky path, so Matinas now benefits from the background by looking back at Amarin's battles, including the case against the FDA (which won). It seems that Amarin is now finally on the verge of winning his long battle, so the path is better suited for Matinas to follow. As MAT9001 continues down the road already traversed by Vazepa, investors will compare the two at each step.

One note of concern from a time perspective is that it may take some time, just as you did with Vascepa. A review of the investor presentation at Matinas does not indicate a specific plan for a clinical outcome study like the one that led to Vazepa's last victory. This may mean that MAT9001 hopes one is not needed, but Matinas is more likely to eventually have to go through the same process as MAT9001, which Amarin did with Vascepa, in order to have a chance to reach potential blockbuster status. We are generally away from Matinas, who has drugs for a blockbuster here, but the stock can still move in tandem with Amarin for some time as Vasepa moves forward.

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