26th Nov 2018 09:05
LONDON (Alliance News) - Respiratory disease-focused pharmaceutical firm Vectura Group PLC said on Monday its phase three study of VR375 in adult and adolescent patients with severe uncontrolled asthma failed to meet its primary endpoint.
The results indicated a trend in the reduction of the rate of clinically significant exacerbations among patients receiving either 1 milligram or 0.5 milligrams doses, taken twice daily during a 52-week period.
However, the results did not reach statistical significance, and the open label arm study - meaning with full transparency with the patient - using a conventional nebuliser, a drug delivery device, failed to reach statistical significance against the placebo.
Financially, VR375 will be fully impaired for 2018, making a negative impact on Vectura's pretax line of GBP40 million. In 2017, Vectura reported a pretax loss of GBP102.2 million.
For 2019, the net impact to earnings before interest, taxes, deprecation and amortisation of revenue is expected to be broadly neutral, it said.
Due to these test results, Vectura said it will not pursue further development or partnering of VR375, and will focus on its ongoing VR647 programme, as well as three additional early stage nebulisation programmes using non-budesonide molecules.
"Although we are disappointed that these results missed statistical significance, I remain confident in our proprietary technology and development capabilities. Vectura remains fully committed to enhancing respiratory medications by developing better formulations and superior inhalation systems for patients," said Chief Medical Officer Gonzalo de Miquel.
Shares in Vectura Group were down 8.4% at 71.05 pence on Monday.
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