One of the biggest movers early week this week in the biotechnology space was AnaptysBio, Inc. (NASDAQ:ANAB). The company, which is based out of San Diego, California, just put out data from a trial investigating one of its lead development assets, a drug called ANB020, which investigation as a potential therapy for adult patients with moderate-to-severe atopic dermatitis.
This is the most common form of eczema and up to 3% of adults in the US are reported to suffer from it. The current standard of care treatments, however, are insufficient as far as market need is concerned. Many involve corticosteroids, which bring with them some pretty strong side effects and, in a portion of the population, just don’t work, and markets are crying out for a fresh alternative to hit shelves in the US near term.
Latest trial data suggests that ANB020 could be that alternative.
The drug is what’s called an IL-33 inhibitor that is its name suggests, binds to interleukin 33 and, in doing so, and potentially inhibit the processes that lead to inflammation (i.e., cytokine release). Many of these dermatology indications are caused by autoimmune-mediated inflammation, so if ANB020 can be effective in this dermatitis indication then it has the potential to go on to pick up approval in a range of the sorts of targets.
Not that this one isn’t big enough to start with, of course. The drug has blockbuster potential in this indication alone in the US.
And that’s why AnaptysBio is moving in response to the news.
So what did the data show?
After a single dose of the drug, 75% of patients achieved an Eczema Area Severity Index (EASI) score, which is a gold standard severity scale in this space, improvement of 50% relative to enrollment baseline (EASI-50) at day 15. Beyond that, 83% of patients achieved EASI-50 at day 29 and 75% of patients achieved EASI-50 at day 57.
Further, all 12 patients achieved EASI-50 at one or more timepoints through Day 57 post-ANB020 administration.
As per the release detailing the numbers, there were no major safety concerns reported by any of the patients in the study meaning the adverse event profile looks clean to date.
There are ways to look at this.
Obviously, the data is incredibly strong as far as interim data in a small population goes. With 100% of patients responding in a predetermined timeframe, there is no argument that the drug seems to be effective to its aim of reducing condition severity. Throw in a clean safety profile and things get even stronger.
On the other side of the equation, however, this is a very small trial in what would eventually be a very large target population. In these sorts of dermatology indications, two phase 3 studies are often required in order to underpin a registration application (NDA, in this case) in the US, meaning there is a long way to go before AnaptysBio and its shareholders can start cheering.
With that said, as far as at-this-point is concerned, things couldn’t really be any better.
There are a couple of key events to watch over the coming 12 months as supportive of the data we have seen and, in turn, as potentially acting as catalysts to compound the current momentum.
The first is extension data based around the same patient population from which the above-discussed numbers were collected. This extension data is measuring the same endpoint (so, percentage improvement based on the EASI scale, but at 140 days as opposed to the 57-day maximum that has been collected so far. This will be topline for the study and, if it falls in line with the data we have already seen, it will be strongly supportive of future success.
Beyond that, a pivotal trial, or two, is likely to initiate at some point during the first half of 2018. This trial will probably involve 200 patients or more (likely more) and initiation, enrollment completion, interim results and top line all represent potential upside catalysts between now and the end of 2018.
At its close subsequent to data release, AnaptysBio went for $70.41 a share, up a little over 101% on its daily open. Premarket on Wednesday, we have seen an extra percentage point added to this and the AnaptysBio currently trades for $71 flat