Neuralstem, Inc. (NASDAQ:CUR) is a big runner at the end of this week, as the company puts out an update on its lead major depressive disorder (MDD) trial. The trial is investigating the safety and efficacy of an asset called NSI-189, and it’s a phase II study.
On the update, Neuralstem, Inc. (NASDAQ:CUR) gained gained close to 20%, and looks set to pick up further strength heading into the close of the week, as sentiment attracts speculative volume. So, in light of the recent action, and in an attempt to ascertain whether it is a) justified and b) indicative of longer term strength, here’s a look at the drug, the trial, and what we are watching for going forward.
As mentioned, its an MDD target and its called NSI-189. The drug is part of a family of drugs deigned as neural regenerators, using the company’s proprietary stem cell platform. It’s a pretty cool technology and by proxy, mechanism of action) for any science fan. Basically, the drug is an attempt to use the brain to repair itself. We’ve got something called the hippocampus in our brains, which is the part of the brain generally accepted as being responsible for things like emotions, memory and the autonomic nervous system. It also plays a key role in the generation of new neurons.
The theory is that certain degenerative effects on the hippocampus (and in turn, the destruction or disabling of neurons) are responsible for a range of different mental conditions – one of which is MDD. With NSI-189, Neuralstem, Inc. (NASDAQ:CUR) is trying to take stem cells from the hippocampus, then reintroduce them to a patient’s brain in an attempt to stimulate the production of neurons that replace those that have been degraded.
And it’s this theory that the trial we are looking at was set up to investigate.
The investigation, which is a double-blind, placebo-controlled study, randomized 220 subjects to one of three oral treatment groups: placebo, 40 mg once daily (QD), 40 mg twice daily (BID). The primary endpoint of the study is a reduction in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). For those not familiar with MADRS, it’s an industry standard depression rating scale and it’s used in a large number of these sorts of studies – especially those that relate to the specific type of MDD investigated here – MDD.
In order to qualify for the study, patients needed to have a MADRS score of 20 or greater at screening and baseline. To add a degree of context to this inclusion criterion, a total MADRS score of 20 to 34 is suggestive of moderate depression while a score of 35 or greater is suggestive of severe depression. So, in other words, these are moderate minimum severity patients.
There are also a number of secondary endpoints in place designed to compliment the primary, and as the company describes in its communication regarding the study, designed to encompass additional clinical outcomes including objective cognition improvement measures.
In other words, the primary is going after the improvement of the primary MDD, while the secondary endpoints are focusing on satellite benefits associated with the reduction in severity of the primary condition.
It’s a twelve week dosing study, with a follow up period of six months during which patients won’t receive any more of the drug, but across which they will be monitored in an attempt to assess the drug’s impact after dosing has stopped.
So, what did the latest announcement tell us, and why is the company running up on the back of it?
Well, to be honest, it didn’t tell us much.
Basically the company has let markets know that the study is now fully enrolled, and that this enrollment has come ahead of schedule. Enrollment can be tough in any trial, and so that the company has brought it home ahead of the planned date is a bit of good news. It also means that the topline from the study, which was initially planned for end year, or early 2018, will now be brought forward (from a release point of view) to the third quarter of 2017.
So that’s what’s driving the action – the data being brought forward.
Is it a long term growth driver? Probably not. Is it good news? Sure.
Note: This article is written by Mark Collins and originally published at Market Exclusive.