LONDON (Alliance News) - Circassia Pharmaceuticals PLC on Monday said it was disappointed by results from its phase III cat allergy study, as there was a "dramatic" placebo effect, and said it will now be considering the implications of the results across its allergy portfolio.
Circassia said that in its study both treatment regimens and the placebo "greatly and equally" reduced subjects' combined allergy symptom and rescue medicated use score from the baseline, meaning the score in both the active treatment groups and the placebo groups were "not significantly different".
However, Circassia noted that the treatment was "well tolerated with a highly favourable safety profile".
The company said it will now review its full dataset to "understand the detailed results and assess whether any other confounding factors affected the outcome, as well as the implications for its allergy portfolio". Until then, Circassia said it will stop the recently initiated registration study of its grass allergy treatment and the preparatory work for a dose-ranging study of its ragweed allergy therapy.
Circassia said its phase IIIb study of its dust mite allergy product is well advanced, and it will assess the implications associated with continuing the trial, while its birch allergy product is nearing completion of a phase II study, which will "therefore continue".
"We are surprised and disappointed by these results. Such a dramatic placebo effect was not a feature of our earlier phase II studies. However, in this large-scale trial, it eliminated the ability to identify a treatment effect despite dramatic improvements in subjects' allergy symptoms and rescue medication use," said Chief Executive Steve Harris.
"We will now rapidly analyse the full dataset, address the implications for our wider allergy pipeline and provide an update on the development plans for our broader business at our interim results. At the same time, we will continue to focus resolutely on our wider portfolio, rapidly growing the sales of our market-leading NIOX asthma management products and advancing our pipeline of respiratory products," Harris added.
Imperial Innocations Group PLC holds a 9.3% stake in Circassia and said that, while the results are "disappointing", that it continues "to be supportive long-term shareholders in Circassia".
By Hannah Boland; hannahboland@alliancenews.com; @Hannaheboland
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