Minerva Neurosciences Inc (NASDAQ:NERV) just served up an update as to the progress of its two lead programs, and the company has remained relatively flat on the insight. There’s an important element, however, that could serve to inject some upside momentum into Minerva’s market capitalization near term, however, and that wider markets seem to have missed.
With this in mind, here’s a look at the update in question, and what we are looking for as indicative of it boosting the company near term.
The information relates to its 24-week open-label extension period of a phase IIb clinical trial of a drug called MIN-101. The drug is targeting efficacy in patients with negative symptoms of schizophrenia. The company announced initial data from the study (top line) back in May, and the trial met both its primary and secondary endpoints.
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Specifically, the drug showed a stat sig benefit of over placebo in improving the above mentioned negative symptoms, as measured by what’s called the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS). This sounds pretty jargon-y, but it basically just refers to an industry standard method of establishing baseline, and in turn, improvement form baseline, in something that would otherwise be pretty difficult to measure. A secondary endpoint, again referencing the PANSS score but this time related to an alternative framework called the three factors negative symptoms subscale, also hit, by demonstrating superiority in the active arm (across two different doses) over a placebo arm. Safety came in with no issues, setting things up nicely for an extension.
It’s this extension that the company referred to in its latest release, and that we are watching closely as potentially acting as an upside catalyst when the numbers hit press.
Before we get into the extension, let’s quickly look at how MIN-101 works. In our brains, we’ve got a number of different types of serotonin receptors, each of which play a role in mood regulation by way of controlling the release, or lack thereof, of serotonin. MIN-101 targets (and blocks) a serotonin receptor called 5-HT2A. In doing so, it reduces the negative symptoms associated with over activity of 5-HT2A – hallucinations, delusions, agitation and thought and movement disorders. It also blocks something called a sigma receptor (specifically, the sigma2 receptor) which modulates dopamine release. This latter impact is designed to improve memory and waking cognitive function. Combine the blocking of 5-HT2A and sigma2, and you can control (or at least, mitigate, to some degree) the elements of schizophrenia that cause patients the most issues.
So that’s the science, and we know that the initial trial proved the hypothesis – what’s the aim of the extension trial and what are we looking for from it?
Well, to put it simply, Minerva Neurosciences Inc (NASDAQ:NERV) is trying to prove that its drug can have an extended benefit (that is, maintain its level of benefit) in patients beyond the scope of the initial study. 140 patients that were part of the initial study advanced in to the extension, comprising patients from both dose levels and the placebo arm. The dose level patients either maintained or switched dosing (without knowing which) while the placebo patients were randomized onto one of the two active doses.
The target endpoints are simple – will the drug maintain its impact based on the same frameworks mentioned above (pentagonal structure and three factors PANSS).
And here’s the exciting part.
The trial completed during the third quarter (the assumption here is that it was mid to late September, so only just completed) and the company is un-blinding and analyzing the data as we speak. Once the analysis is complete, Minerva will put out topline from the extension, with a target of mid fourth quarter.
Why is this exciting?
Because last time the company put out data supportive of an efficacy bias with MIN-101, the company jumped nearly 250%. If the extension data supports the initial hypothesis – that is, if it suggests the drug is effective beyond the initial trial period – then it will massively increase the potential market for the drug.
That’s why this is important, and that’s what markets seem to be overlooking right now.
