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George Ronan
George Ronan
Articles (67) 

Aimmune Therapeutics Is Moving on Allergy Data

Here's a look at the latest data from Aimmune and what it means for the company

February 21, 2018 | About:

Aimmune Therapeutics Inc. (NASDAQ:AIMT) is moving this week on the back of some fresh news related to the company’s pipeline. 

The company announced on Tuesday some data from a phase III trial investigating its lead development asset. The trial in question is called PALISADE and it was put in place to investigate the safety and efficacy of an asset called AR101 in patients with peanut allergy.

Peanut allergy is a major issue in the U.S. and globally right now, with around 1% of people suffering from the condition. That doesn’t sound like a lot right off the bat but when you consider that 1% of the U.S. population amounts to more than 3.2 million individuals, the market seems far larger. And that’s not really the key point. The important thing here is that there are only responsive therapies available to these patients, in the sense that they only have treatment options after they have developed an allergic reaction.

This asset, AR101, is designed to be a preventative, meaning it’s designed as an asset that these patients can take in an attempt to essentially help them overcome their allergy, ahead of (and, importantly, as a preventative against) any attack.

For anyone not familiar with how these sorts of preventatives work, it’s essentially a tiny amount of peanut (measured and turned into flour) in a capsule. The patient takes the capsules on a daily basis, with the idea being that she can build up a resistance to peanuts over time.

It’s novel, but perfectly logical.

So what did the data show?

Per the data, 67% of patients ended up tolerating at least a 600-mg dose of peanut compared to 4% of placebo patients. That’s a pretty incredible result. Additionally, the data also showed that 50% of patients tolerated a 1000-mg dose compared to 2.4% of placebo patients.

There were some concerns, however.

Specifically, Aimmune noted a 20% dropout rate with around 12% withdrawing due to treatment-related adverse events.

That’s pretty high for a phase III study and, at a glance, could be concerning.

What does all this mean? Is it a concern?

Well, perhaps not. These are, after all, patients who are receiving the very thing that makes them unwell in the first place. That they respond to it badly in a small number of cases isn’t really surprising – especially given the fact that the severity of the allergy varies and, by proxy, the dosing isn’t an exact science.

What comes next?

The uncertainty surrounding the results is reflected in the market response to the news. The company initially ran to the tune of 20% premarket as the results hit press but dropped into the close by 6%.

Subsequent to the close, Aimmune also announced an underwritten public offering of up to $150 million of shares of its common stock, which pushed shares down further.

Next, it’s all about getting this asset in front of the FDA to see what the agency’s take is. There is a decent chance of approval, even given the concerns of the adverse event rate, based on the fact that this sort of thing can be reduced (from a risk standpoint) by close early stage monitoring post-approval.

Disclosure: The author has no positions in any of the stocks mentioned in this piece.

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