The management team over at CytoDyn Inc (OTCMKTS:CYDY) are set to host a conference call later on today, aimed at discussing the progress of the company’s development pipeline and so called regulatory developments associated with the assets that comprise said pipeline.
Regular readers will know that this is one we covered quite a lot towards the end of last year, and we highlighted a number of catalysts to keep an eye on throughout 2017 as potentially serving up some upside momentum.
We expect that the upcoming call will focus both on these catalysts and (and this is likely the driver behind management setting it up) the FDA’s turning down of an application by CytoDyn for Orphan Drug Designation for its lead development asset – PRO 140.
This latter development hit press yesterday.
We’re going to sit in on the call to see how it plays out, and we’ll adjust our bias (and update our readers to that aim) based on what we hear. Ahead of it taking place, however, here’s what the latest news means, and what we’re looking for from the call.
For those new to the company, CytoDyn is trying to get the above mentioned PRO-140 approved as an HIV drug. For want of a softer way to put it, the HIV therapy space is in crisis. There’s a handful of antivirals on the market right now, of which HIV patients need to take a combination (generally three) to keep their viral load at safe levels. Some combinations work better for some patients than others, but all only last a certain amount of time, and resistance force patients to switch combinations regularly. When the combos run out, so do the treatment options.
PRO 140 uses a novel MOA designed to stop the virus from replicating. We won’t get into the science in too much detail here, but to simplify, the drug blocks one of the receptors that the virus needs to activate to enter T cells. If the virus can’t active the receptor (because it’s blocked by PRO 140, it can’t enter the cell, and when the cell replicates, it won’t be replicating with a virus inside it (which is how HIV spreads within the body).
So that’s the science. The key to this whole story is that CytoDyn is trying to get this drug approved in two distinct ways. First, as a combination treatment for use alongside the current antivirals, in patients that have become resistant to standard combinations. Second, as a standalone treatment (a monotherapy) in HIV patients.
The first is a small (relatively speaking) population, but it should be the easier approval. This is the population for which CytoDyn applied for Orphan Drug designation, as the total size is below the 200,000 threshold required for ODD qualification.
So why has the FDA declined the application? Well, because the agency thinks the drug might also be able to treat the entire population of HIV sufferers (so, that it might work as a monotherapy) and this expands the numbers way beyond the just mentioned threshold.
In this sense, then, the decline is a bit of a bump, but it actually bodes well for the development pathway longer term. The monotherapy is the real blockbuster indication here, and any indication of potential efficacy in this group is a great bit of news.
So what are we looking for on the call?
We expect management to clarify the point we just made, first of all. After that, we’re looking for some insight into the data release timeline from the drug’s pivotal in the combination regimen.
If clarification comes (and there’s the potential for a mid year release) then we expect this one to run post-call.
As we say, we’ll sit in and update when we know more.
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Disclosure: We have no position in CYDY and have not been compensated for this article.