A phase 3 trial of Vectura’s VR475 in patients with severe uncontrolled asthma has missed its primary endpoint. The blow prompted Vectura to halt work on the nebulized formulation of budesonide.
Vectura acquired the rights to VR475, then known as Favolir, in 2014 through its €130 million ($148 million) takeover of Germany’s Activaero. Back then, Vectura talked up the prospect of filing for EMA approval in 2017. That target got pushed back to 2018 the year after the acquisition when Vectura decided to go after a broader patient population, and slipped further as the phase 3 trial progressed.
Now, the prospect of a filing for approval of VR475 has disappeared entirely. Neither dose of VR475 tested in the 52-week trial reduced the annualized rate of significant exacerbations by statistically more than placebo. Vectura reported numerical improvements in both arms.
Some of the secondary endpoints achieved statistical significance, but those hints of efficacy failed to persuade Vectura that VR475 has a future. Vectura is continuing to analyze the data in preparation for publication but has scrapped plans to further develop and partner the drug. At one stage, the company planned to initiate a pivotal U.S. trial after wrapping up the European study.
The failure of VR475 had an immediate effect on Vectura’s finances. With Vectura fully impairing the value of the intangible asset, the company will take a £40 million hit before tax in the current fiscal year. News of the setback sent Vectura’s stock down 8% in early trading in London.
Vectura’s sliding stock reflects the loss of a near-term commercial opportunity from a candidate the company had placed a relatively large bet on. Despite that, Vectura sought to play up the positives, notably by emphasizing points that suggest the delivery system used by VR475 still has potential. A follow-up candidate, VR647, uses the same nebulized delivery system.
With an open label arm that delivered budesonide via a conventional nebulizer also failing to beat the placebo, Vectura thinks the fault lies with the drug, not the device used to deliver it. That idea will be put to the test when VR647 moves into a planned phase 3 trial.