Amarin (AMRN, Financial) isn’t the only company celebrating Vascepa’s win with a Food and Drug Administration advisory committee last week. Matinas BioPharma (MTNB, Financial) is riding Vascepa’s wave, too. In fact, over the last month, the two stocks have moved up almost identically. If the FDA decides to follow the advice of its panel and approve Vascepa for use on top of statins to reduce the risk of cardiovascular events, Matinas could keep chugging higher along with Amarin. Here’s why.
Vascepa is a prescription-only omega-3 fatty acid (EPA) drug that proved last year in a successful phase III cardiovascular outcomes trial that it could reduce the risk of cardiovascular events by 25% as an add-on to statins. The only question was whether the mineral oil placebo used in that trial inadvertently interfered with statin absorption, which may have skewed results in favor of the Vascepa arm. The FDA itself had decided that the evidence was inconclusive, and so the committee did not hesitate to unanimously recommend Vascepa as an add-on therapy to statins in these patients.
Now let’s rewind four years. Back in 2015, Matinas was conducting a phase I trial of its own omega 3 drug MAT9001, comparing it directly with Vascepa. The trial had an unusual setup in that only 42 people were enrolled, but the trial was actually powered as if double that number were being tested. First, all 42 were randomized to either receive MAT9001 or Vascepa, four capsules per day for 14 days. This was followed by a five-week washout period, and then the drugs were switched on all subjects.
There are three data points from the trial that are worth mentioning specifically. First, MAT9001 was much more effective than Vascepa at reducing triglycerides and VLDL-C. MAT9001 saw a 33.2% reduction from baseline versus 10.5% for Vascepa, and VLDL-C reduction was at 32.5% versus 8.1% for Vascepa. Second, MAT9001 was able to reduce PCSK9 levels by 12.3% whereas Vascepa showed PCSK9 levels actually rising 8.8%.
The significance of that last point is that PCSK9 is the target for cholesterol drugs like Regeneron’s (REGN) Praluent and Amgen’s (AMGN) Repatha, so a reduction in this number could be especially significant. Third, the amount of active omega 3 fatty acid drug measured in blood plasma was about 6.5 times higher for MAT9001 than for Vascepa.
Despite that trial’s success, Matinas put MAT9001 on the backburner while it used its resources to develop its lead antifungal candidate. The company has since revived MAT9001, and a 100-patient Phase II crossover head-to-head trial (again powered as if 200 are enrolled) against Vascepa on patients with high triglycerides will begin dosing next quarter, with results expected by the end of 2020.
None of this of course proves that MAT9001 will succeed, and ultimately for the stock that is what matters. Still, what is interesting is that Amarin has been down this rocky path already, so Matinas now has the benefit of hindsight looking back at Amarin’s battles, including a lawsuit against the FDA itself (which it won). It seems Amarin is now finally on the verge of winning its long fight, so the path is better paved for Matinas to follow. As MAT9001 continues down the road that Vascepa has already traveled, investors will be comparing the two every step of the way.
One note of concern in terms of timing is that this could take a while, just as it did with Vascepa. A look at the Matinas investor presentation shows no specific plan in place for a clinical outcomes study such as the one that led to Vascepa’s latest victory. That could mean that MAT9001 is hoping one may not be necessary, but it is more likely that Matinas will eventually have to go through the same process with MAT9001 that Amarin did with Vascepa in order to have a chance of reaching potential blockbuster status. Basically, we are likely years off from Matinas having a blockbuster drug here, but nonetheless the stock could continue moving in tandem with Amarin for a while as Vascepa moves forward.
Disclosure: No positions
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