Woodford23 Jun 2016 17:07
Interesting statement by Neil Woodford
"We want you to know about an update we have received from one of our portfolio companies this morning, Circassia. It has this morning announced the failure of its high-profile phase III study into its cat allergy vaccine. We have just met with the company and would like to share our latest thoughts with you following this announcement.
Neil Woodford
20 June 2016, 16:33
4 min read
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This is undoubtedly a disappointing development. We had high hopes for this trial and are therefore surprised at its failure, particularly when you consider some of the positive aspects of the trial data. The drug has demonstrated a very positive effect, with patients on all doses of the treatment showing a 60% improvement in their symptoms with a very good safety profile. This is better than we had expected – in fact, it’s better than anyone had expected.
The problem is, the trial results also showed a dramatic placebo effect. The trial was being conducted on people with a severe allergic reaction to cats – whether these people had been administered the drug or a placebo, the trial results showed broadly the same impact on symptoms.
This is unprecedented – such a placebo effect hadn’t been seen before in earlier studies on Circassia’s cat allergy product, any of its other potential allergy treatments, or indeed in competitor’s studies in allergy. It is highly unusual to see such a high placebo effect in a clinical study and it is difficult to explain how and why such an effect has been seen.
We had a meeting with Circassia’s management team earlier today to get a full and comprehensive update on this trial disappointment and on the company’s wider performance. The company is in the process of analysing the full dataset to try to better understand this placebo riddle and what it means for its wider allergy pipeline as soon as it can. It has already announced that it is halting investment in its earlier-stage allergy trials until it better understands these results. There are two mature trials which will continue to completion: a phase IIb study in house dust mite allergy and a phase II trial in birch allergy. We would be pleased if these trials demonstrate such a strong effect on patients as the cat allergy phase III study, but at this stage, it is impossible to know if the unusual placebo effect will be evident in these trials also."