So that’s another week pretty much complete in the biotechnology space and what a week we’ve had. Multiple companies have gained and lost strength on inputs of all shapes and sizes and we’ve tried put forward our expectations for each as they’ve happened. We’ve got a couple more to look at today before the week closes out.
Here’s a look at which companies are end of the week movers, what’s moving them and where we expect each to run next.
The two companies we have in our crosshairs today are Selecta Biosciences, Inc. (NASDAQ:SELB) and Adamis Pharmaceuticals Corporation (NASDAQ:ADMP).
First up, then, Selecta.
This one’s a data-driven move.
Select put out data from an ongoing phase II study of its lead development asset on Thursday and the company has picked up some strength on the back of the news. The asset in question is called SEL-212 and Selecta is trying to bring it to market across multiple indications, but with this specific program, in a target population of severe gout sufferers.
The idea behind this asset is that many of the currently available options for this condition have pretty nasty side effects, often rooted in unwanted immune responses. If Selecta can get its asset on shelves, there’s a good chance the company can snap up a decent portion of the market.
So what did the data show?
Well, there were two arms of the study, one looking at an SOC drug called pegsiticase and another looking at a combination of pegsiticase and the development drug in question, SEL-212. As per the release, 15% of patients that received a combination of SEL-212 and SCO reported a gout flare (defined as a sudden and severe attack of pain) in the first month of treatment, with reports declining further in subsequent months. This compares with 50% of patients treated with pegsiticase alone who reported a gout flare.
The safety profile, importantly, was relatively clean.
The point of this study was to set up a minimum effective monthly dose that can be used in a phase III study. Another study is going to have to be carried out to establish maximum tolerable dose, and the combination of the two outcomes will combine to set up the protocol for a pivotal study.
The key thing here is that this is a minimum tolerable dose study that still managed to put forward a strong efficacy result. When the maximum tolerable dose is established, the implication is that there should be an even higher discrepancy between active and control. If this is the case, and if the pivotal is able to replicate the early stage numbers, the drug should be a shoo-in for approval.
Of course, these are two big Ifs, and there are no guarantees at this end of the biotech space. Markets are taking an optimistic stance, however, and the company currently trades at a 10% premium on its pre-release capitalization. Chances are we’re going to see this one continue to gain strength as the week draws to a close, but not dramatically. All eyes are now on the forward steps (maximum tolerable dose establishment) and the pivotal trial that will follow.
Moving on, Adamis.
This one’s been a long time coming. The company has been trying to get what amounts to a generic version of Mylan’s EpiPen to market for the past couple of years (and that’s not including development, we’re just talking application to approval) and has suffered repeated setback along the way. The FDA in the US issued two Complete Response Letters (CRLs) to Adamis based on various concerns (primarily relating to the mechanism of injection, and whether it’s sufficiently usable so as not to confuse patients) and shareholders (and indeed, wider markets) were seemingly resigned to a failed program.
Yesterday, however, the agency gave the asset a regulatory green light.
The company is trading up more than 50% on the news and will likely gain further strength as the week closes and – beyond – into next week.
This is an important development because the Mylan version has been subject to scrutiny based on price hikes. This asset is going to be far cheaper (half the price, if estimated prove correct) and Adamis should be able to quickly attract a large portion of this billion-dollar emergency treatment market as a result.