Evoke Pharma Inc (NASDAQ:EVOK) is running up on news of a successful meeting with the FDA, during which the company got confirmation of what amounts to a streamlined path to commercialization for its lead gastrointestinal diseases asset, Gimoti.
The primary gains came before the close on Friday, when Evoke traded up to the tune of 44% on its session open. However, as we head into the start of the US session on Monday, the company is maintaining its momentum, and is up a further four percentage points, hinting at some early week strength.
That’s a 50% revaluation in a short period. Did the news warrant these gains? Additionally, is there more upside to be taken advantage of, or are things likely to settle near term? Let’s take a look.
So, the news relates to the above mentioned Gimoti. Evoke Pharma Inc (NASDAQ:EVOK) is developing the drug as a target for relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. It’s not an entirely new asset, it’s a reformulation of a currently widely used drug called metoclopramide. Metoclopramide is currently available in tablet form, and is used as SOC in many regions across the globe as a GI complication treatment. However, with the nature of the target indication being as it is, some patients have difficulty taking the drug in pill form. Further, it’s not particularly fast acting – as with any pill for drug it needs a systemic pass before it gets to work.
Gimoti is Evoke’s patented nasal delivery formulation of metoclopramide. It’s a nasal spray, and it’s designed for quick delivery and activation.
Before we get in to the latest news, there’s a bit of history worth looking at. Gimoti completed a phase III back in July, and failed to meet a primary endpoint of efficacy in that study. At that point, the company collapsed in value, falling from more than $10 a share to around $1 a share across a period of two or three days. Since then, Evoke has traded pretty much flat, this latest run up aside.
So why did the latest news have such an impact?
Well, when a drug misses a primary like this, the assumption is that it’s not going to get FDA approval. However, the miss was a surprise given the long standing efficacy reputation of the drug in pill form. As such, Evoke sat down with the agency to try and sort out a path forward. In the latest news, we learnt that the FDA has agreed to consider the drug for approval if Evoke can put together some data showing that Gimoti is bioequivalent, from a pharmacokinetic (PK) perspective, to a marketed version of metoclopramide called Reglan. If Evoke can demonstrate bioequivalence, the FDA has suggested it will allow the company to bundle this data with some previously collected safety and tolerability data, and use the sum as the basis of an NDA. It’s a 505(b)(2), which should speed up the process if Evoke gets that far, so basically the drug is back on track and has the endpoint miss in its rear view mirror.
So, what’s next?
Well, Evoke Pharma Inc (NASDAQ:EVOK) obviously now has to get this study underway. PK studies are generally pretty quick, and enrollment is easy because (in all likelihood) Evoke will run the trial in healthy volunteers. As such, we expect a first quarter initiation and completion for the study, with data hitting press at some point late first quarter (at the outside end – it could come a lot sooner). Once this data is in hand, and assuming it’s positive (i.e. it demonstrates that Gimoti has a similar PK profile to the oral formulation metoclopramide) then Evoke should be able to collect everything together and bundle it in to an application within a few weeks, a month at the outside.
With this in mind, we’re looking at a mid 2017 submission for the 505(b)(2) NDA for Gimoti, and a subsequent approval before the end of the year (based on its 505(b)(2) pathway status).
Now it’s all about getting this PK data in hand. That’s the crux of this pathway going forward.
Note: This article is written by Mark Collins and originally published at Market Exclusive.