DBV Technologies S.A. (NASDAQ:DBVT) is attracting a lot of attention right now. The company just put out some data from what could prove to be a game changing mid-stage trial and has picked up some strength on the back of the release. Exactly what the data means, however, is subject to some uncertainty.
Why?
Well, it’s a bit mixed.
Here’s what happened and what it means going forward.
So, the asset in question is called Viaskin Milk and it’s designed to be a milk patch that patients wear across a twelve-month period. A milk patch, that is, that delivers a small dose of milk (in the form of a dry milk protein) to the patient through his or her skin over the above mentioned twelve month period. This is a novel approach to this sort of condition but it’s one that has shown to work in certain conditions and with certain other allergy patients. Perhaps most famously, at least right now, the concept is being applied to peanut allergy patients through the use of a pill that delivers a small amount of peanut powder in a capsule to the patient over time, with resistance building up towards (and, ideally, to) the level of an individual that’s not allergic to various allergens.
So, what did the latest news tell us?
The study enrolled 198 patients (all of which were children between the ages of 2 to 17 and each of these children randomized them to receive one of three doses of Viaskin Milk or placebo. The endpoint revolved around proving whether the increasing dose could improve patients’ response (in terms of their reaction to an exposure to milk protein) over time.
Now, let’s get to the data.
Here’s the headline snippet:
“Positive preliminary results support Viaskin Milk`s potential as the first treatment for patients suffering from IgE-mediated cow`s milk protein allergy (CMPA), an unmet medical need for which there are no approved therapies.”
That’s a clearly positive statement, but do the numbers support it?
Well, as mentioned in the introduction to this piece, things are a little mixed. It’s positive, sure, but there’s an addendum – one we’ll get to in a moment. First, let’s address the good news.
As per the results, the 300 µg dose was identified as the most effective tested dose for children (intent-to-treat (ITT), p=0.042). This isnt overly suprising, since it’s the middle dose and we would expect the middle dose of a range to serve up a nice balance between safety and efficacy, but it’s also a great (for the company and its shareholders) result because it shows that the clinical trial was designed to perfection and, in turn, that the company has a strong idea of its optimum dose with which to move into the later stages of the development program.
Overall, 98.9% of patients completing month-12 of MILES opted to enroll in the open-label portion of the study and are currently being treated with Viaskin Milk 500 µg for up to 48 months, meaning tolerability isn’t a major concern as things move forward which, again, for a trial like this, is a real boon heading into the later stages of the investigation.
So we saw a clear sign of efficacy on a medium dose, a pretty clean safety and tolerability profile across all patients tested – why are we saying the data was mixed?
It’s all about trial size.
This investigation was limited in size to the above mentioned 198 patients, all of which were children. This wouldn’t normally be an issue, but when you are breaking this small group up into for even smaller groups (three doses and a placebo arm) it reduces the significance of the data as and when it hits press.
To put this another way, the data was positive but not necessarily strong, based on the fact that it’s supported by such a small sample size.
So what’s next?
Well it’s now all about expanding into a pivotal and following up on the data from the patients that have crossed over from the trial that just read out.
Despite the mixed nature of the news, DBV is picking up strength on the development and currently trades for around $21.36 a share.
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