Circassia CEO Steve Harris has defended the running of the company’s allergy trials, stating nothing could have been done better. Harris made the comments after presenting annual results that mark another step in the transition of Circassia away from its original area of focus.
The British company halted investment in its allergy programs last week after a dust mite clinical trial became the latest to deliver subpar data. Like the earlier failures of ragweed and cat allergy trials, Circassia attributed the setback to the strength of the response to placebo, arguing the assets have biologic activity but were undone by the performance of the sham therapy. An alternative interpretation is that the allergy drugs are ineffective.
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As Harris sees it, the difficulty in overcoming the placebo effect stems from “the field study designs required by regulators.” And, faced with that, he argues Circassia did the best it could with the allergy R&D programs.
“Do I think we've done anything that we could have done better? Actually, I think we've done a very good job. I think we showed some very strong data in phase 2 studies. We've had all of the great and the good in the allergy world crawl all over [the phase 3 studies]. I think everybody agrees it was a well-designed, well-executed study. So I don't think there's anything I feel we could have done differently. I think this is the problem with pharmaceutical development,” Harris said.
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The rebooting of Circassia as a commercial-stage respiratory specialty pharma means there is less scope for the boom or bust nature of drug development to hurt the company now. Harris’ focus is on two assets that are already on the market—the Niox asthma management products and the Tudorza bronchodilator—and a third that is in phase 3 sponsored by AstraZeneca. Data on the third product, Duaklir, are due later this year.
If Duaklir can build on the data that enabled it to win approval in Europe by delivering positive results in its current trial, Circassia will be well on its way to having a small stable of commercial products in the U.S.
“We have three products that have peak sales potential of around $500 million. That's a fairly exciting place to be,” Harris said. What it isn’t is where Circassia and its investors hoped to be in 2017 when the company made a splash with its £200 million ($257 million) IPO.
The size of the IPO and subsequent financings mean Circassia has money to support its operation while the commercial business gets going. To make its cash go further and adapt to the clinical trial failures, Circassia has shuttered the Chicago office it opened to serve its allergy unit and a Swedish site it gained in the acquisition of Aerocrine.