Bayer AG (ADR) (OTCMKTS:BAYRY) is Pitching for a Big Win in Heart Failure

Heart failure is big business. The condition affects more than one in five humans, and accounts for as high as 50% of all deaths in the US, with about 5 million US individuals currently affected and more than 200,000 diagnosed each year. The FDA approved Novartis AG’s (NYSE:NVS) Entresto in July last year, and the EMA did the same for EU use a few months later, and analysts are putting a 2020 revenues estimate of close to $10 billion in the more optimistic projections.

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Of course, with projections this high, a host of other companies are scrambling to develop their own candidate. One of the most promising is Finerenone, Bayer AG (OTCMKTS:BAYRY). The drug is currently in phase III trials, and if Bayer can replicate the results demonstrated in a 2015 completion phase IIb, the company could get a real shot at competing with Novartis for a portion of the 2020 ten-times blockbuster revenues pot. An NDA submission is a few years down the line, with the trials not expected to complete before early 2019, but there’s the potential for plenty of interim releases over the coming 24-36 months, and in turn, some upside catalysts.

Here’s a look at the trial design, the drug in question, and what to look out for on any updates.

So, Finerenone is what’s called an antimineralocorticoid – similar to the more well known eplerenone, but different in one key element: it’s not steroidal. Why is this important? Well, the drug’s mechanism of action involves the blocking of the mineralocorticoid receptor, which is a receptor found in the heart (as well as other places in the body, but that’s not important for the purposes of this discussion) that is responsible for water and sodium travel, distribution and uptake. By blocking this receptor, these types of drugs treat chronic heart disease. However, they also block three other receptors: glucocorticoid, androgen and progesterone. The blocking of the mineralocorticoid receptor treats heart disease. Blocking of the other three cause unwanted side effects. Finerenone blocks the other three in far lower concentrations (we won’t go into the numbers here, but they are available at this link) than the currently available antimineralocorticoids, meaning it is (theoretically) an alternative, safer version of current SOCs.

It’s this distinction that Beyer is targeting with it’s potential NDA, so all the drug needs to do is demonstrate clinical equivalence and an improved safety profile.

Which brings us to the trial.

It’s a double blind trial that is designed to do exactly what we’ve just described – compare Finerenone to eplerenone. Enrollment is targeted at 3,600 patients, which would be a large number in another indication but should be easily achievable in CHF, and patients will receive varying doses (10-20mg for Finerenone and 25-50mg for eplerenone) across a three-year period. It’s a pretty blunt primary endpoint – time to CV death or or hospitalization. Both arms will take concurrent SOC, which an ACE inhibitor and a beta blocker, across the extent of the trial.

So what are we looking for in interim as insight into the chances of an agency green light? Well, from an efficacy perspective, we want to see comparable stats across the two drugs in hospitalization frequency, time to first hospitalization throughout the trial. Similar stats (combined with similar primary stats on completion) should be more than enough to meet the clinical equivalence requirements of the FDA. Safety and tolerability is (unusually) much more important in this one. If the drug can demonstrate a lower AE rate, which the phase IIb we mentioned a little earlier suggests it can, then it would be a real upside catalyst.

So there we go. As mentioned, it’s a three-year trial, so topline should come in the first or second quarter of 2019, which would allow for an NDA submission just in time to take a shot at some of the $10 billion revenues slated to become available at the turn of the next decade. One to watch.

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