Vectura asthma drug-device combo fails in Phase 3 study

Dive Brief:

British drugmaker Vectura Group will give up on developing a drug-device combination after it failed to reach statistical significance in treating severe uncontrolled asthma in a Phase 3 study, the company said Monday.
While the pharma will abandon VR475, which delivered budesonide through Vectura's nebulizer inhalation system, company executives said they remain confident in carrying on with another candidate, VR647, and three early-stage nebulization programs announced earlier this year.
The company stated giving up on VR475 will result in a pre-tax loss of £40 million, or $51 million, for this financial year. Vectura's stock tumbled down on the London Stock Exchange throughout Monday, down roughly 8% by the end of the British trading day.

Dive Insight:

Vectura has seen its share price drop roughly 40% since January. Through the first half of 2018, the company posted an operating loss of £30.2 million ($38.7 million), with revenue up a little more than 1% from the same period in 2017.

While missing on a Phase 3 primary endpoint and ditching a late-stage therapeutic candidate adds to a troublesome year for Vectura, company executives said the results did "reinforce the differential characteristics" with its inhalation system.

One reason for failure could be the primary goal being to reduce clinically significant exacerbations, which the study's principal investigator, Tim Harrison, said "presented a high hurdle from the outset" for a difficult-to-treat population, in a Nov. 26 statement.

"Whether there is a specific severe asthma phenotype who could gain greater benefit remains a distinct possibility," Harrison, who is also a professor at the University of Nottingham, said. "I believe the technology behind VR475 has the potential to be beneficial in the treatment of a wide range of respiratory diseases including asthma."

VR647, another drug-device combo using the company's inhalation system, will continue to be developed. That therapy is set to begin a pivotal Phase 3 trial soon, following successful Phase 2 results posted in August.

In 2014, Vectura bought Activaero in a deal worth £130 million, or about $205 million, handing it VR475. The Phase 3 trial of the drug tested 713 patients in European countries with severe, uncontrolled asthma.

Earlier this month, the British pharma partnered with Hikma Pharmaceuticals to develop generic versions of GlaxoSmithKline's Ellipta respiratory medicines. Also in the trend of deal-making, Vectura stated in a Nov. 26 presentation it has ongoing partnering discussions about VR647 in the U.S.

The company stated it will publish the Phase 3 data after a full analysis in a peer-reviewed journal and present it at an unspecified medical conference.