The week is now well underway and there are a couple of major developments in the biotechnology space, both of which are related to the release of clinical trial data and both of which have translated to some real volatility in the market capitalization of the companies to which they relate.
The two companies in focus for our analysis today are AnaptysBio, Inc. (NASDAQ:ANAB) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN).
First up, then, AnaptysBio.
This one is rooted in the release of some topline proof of concept data from an interim analysis of a phase 2 trial. At a glance, that sounds pretty convoluted – how can topline data be drawn from an interim analysis – but, in reality, it’s relatively simple. The patients are recorded as completed subsequent to dosing and feedback, meaning topline data can be recorded as these completions come in, even before the full population is dosed.
So, back to the trial, the study was set up to investigate the safety and efficacy of a drug called ANB020, which AnaptysBio wants to show can be an effective treatment for patients with peanut allergy.
This is actually a pretty novel treatment and it is one that has drawn a substantial amount of media attention outside of the biotechnology space, purely rooted in the way that it is supposed to work. Essentially, it’s designed to block the activity of what is called IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, including atopic dermatitis, food allergies and asthma.
The idea, then, is that through the blocking the cytokine responsible for inflammation, the physical response to the introduction of an allergen is mediated.
So, what did the data tell us? Can this be an effective treatment in this space?
Well, based on these numbers alone, yes.
Six of 13 (46%) patients administered a single dose of ANB020 improved peanut tolerance compared to none of the three placebo dosed patients. Additionally, the company noted that of the two ANB020 dosed and two placebo dosed patients that were excluded, both patients on placebo experienced an improved peanut tolerance.
So, what is next?
Well, now, the focus turns to the remainder of the patients still to be dosed on the trial and the question will be asked as to whether these patients will continue to show a positive response to a single-dose treatment.
If so, there is a good chance we will see a continuation of the shift to positive sentiment that we have seen in this company over the last 24 hours or so.
Premarket on Tuesday, AnaptysBio is trading for close to 9% premium to the price at which the company closed out the session on Monday.
Next up, Biohaven.
As mentioned in the introduction to this piece, this company is also moving on the release of some data but, unlike the situation with AnaptysBio, this one is somewhat complicated.
The trial was a phase 3 study set up to investigate the potential for using rimegepant (BHV-3000) for the treatment of migraines and, as per the latest results, the trial has hit its co-primary endpoints to secure what, at a glance, looks like a successful completion.
As mentioned, however, this one’s not particularly cut and dry.
The data that hit press does seem to fall short, at first glance, of other drugs that have recently read out in a similar indication and that employ a similar mechanism of action to counter this condition.
As such, all eyes are now on a second trial of the same drug which is set to read out before the end of the first half of this year.
This uncertainty is reflected in the company’s current share price, which currently sits at an around 8% discount to its level at the start of the session on Monday.
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