Circassia Pharmaceuticals’s study of house dust mite allergy immunotherapy phase IIb field study failed to meed its primary endpoint, the company said Tuesday.
Circassia said that both the active treatment and placebo greatly reduced subjects’ allergy symptoms and rescue medication use. As a result, the treatment did not show a significant effect compared with placebo and the study did not meet its primary endpoint. The results show the immunotherapy was well tolerated with a highly favourable safety profile.
Steve Harris, Circassia’s Chief Executive, was disappointed by the outcome. “Although subjects receiving the immunotherapies in both these studies had greatly improved allergy symptoms, the strong placebo effect made it highly challenging to achieve the studies’ endpoints,” he said.
“We remain convinced that the technology has biologic activity, but we also believe the difficulty in overcoming the placebo effect using the field study designs required by regulators represents a significant hurdle, and consequently we will make no further investment in our allergy portfolio,” Harris said.
He added that the company would put focus on its other respiratory business, in particular its new US commercial collaboration with AstraZeneca for Tudorza and Duaklir, its asthma management NIOX franchise and the development of its broader respiratory portfolio.
Following the receipt of disappointing cat allergy phase III results in June last year, Circassia halted significant new investment in its allergy portfolio while awaiting the outcome of its house dust mite field study.