Investors see no end in sight to the misery of hayfever

Twin setbacks for grass pollen allergy projects in development by Asit Biotech and Allergy Therapeutics expose an existential crisis.

Trial Results

Is the short-course hayfever vaccine space investable any more? Investors in Asit Biotech and Allergy Therapeutics will rightly be asking themselves this question in a week that has seen both companies set back – yet again – in their quest to develop treatments for grass pollen allergy.

Asit flunked its second phase III study with gp-ASIT+ despite earlier claiming that the grass pollen season had been strong, mirroring the failure of Allergy’s birch pollen project earlier this year. And today Allergy turned its own pivotal plan for a grass pollen product upside-down, likely delaying launch to 2026.

The Allergy programme, Grass MATA MPL, had already been extensively delayed, and was to have started phase III imminently, but the failure of Birch MATA MPL in birch pollen allergy earlier this year has apparently prompted some soul-searching (Allergy’s lesson: don’t bet on studies that have been delayed, March 18, 2019).

At least Allergy can afford to run the new, extended pivotal programme. No such luck for Asit, which on Monday fell 82%, leaving it with a market cap of around €8m ($9m), €3.8m in cash and a €5m convertible debt coming due next year; even the normally bullish analysts at Edison said they did not see how Asit could continue to fund operations.

Why?

One problem is that it is still not entirely clear why these types of allergy studies keep failing. The collapse of Asit’s first phase III trial of gp-ASIT+ was blamed on subject variability and a poor pollen season, but the second study’s execution was “flawless”, the group said.

Despite this it yielded a result that was significant only in statistical terms, failing to meet a prespecified threshold for clinical relevance. Moreover, this trial took place during a strong allergy season.

Similarly, Allergy’s Birch MATA MPL flunked phase III despite having been run during one of the severest birch pollen seasons of recent years. Like Asit, Allergy has been unable to explain its failure.

Nevertheless, the setback resulted in Allergy deciding today to run a pivotal trial of Grass MATA MPL over not one but two allergy seasons, 2020/21 and 2021/22. This is intended to allow an interim look at the data before deciding whether to continue.

Confounding

Such a plan might make perfect sense where caution is called for, but it threatens to introduce a further confounding factor into an already complex dataset: where variability between patients and centres is already a problem, adding on top of that the variability of two separate allergy seasons could make this trial a write-off.

Even if this study reads out positively launch will be delayed by another 12 months, until 2026, Stifel analysts reckon. Such a timeframe, investors will note, would put launch nearly 20 years after Allergy’s clinical programme was first delayed by a US hold.

Such lack of progress builds on already poor precedent. Alk-Abelló and Stallergenes have developed promising sublingual vaccines, but these have failed to sell strongly, and the latter was recently merged with the private UK company Greer Laboratories.

True, at the acute end of the space the peanut allergy companies Aimmune and DBV have had a better time of it, but for those tackling chronic, seasonal disorders time is running out. Merck & Co, for instance, threw in the towel in 2016, and it is hard to see why many investors would bother having a hand in these technologies.

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