Vectura has opted to ax its most advanced, wholly owned therapy after it failed a pivotal Phase III study for asthma.
Researchers used a nebulizer to deliver doses of budesonide to patients, but the positive trend line they cited for VR475 never hit statistical significance against a placebo. The failure marks a notable setback for Vectura (LSE: VEC), which saw shares slide 12% on the news.
Oral budesonide has been used to treat Crohn’s disease and ulcerative colitis, and the inhaled version is used with a bronchodilator to end symptoms of an asthma attack — so Vectura wasn’t make a leap into the unknown.
Vectura develops generics as well as novel drugs, but it’s been struggling to perform on plan since its $621 million Skyepharma buyout in early 2016. In a nasty setback last March, Vectura and their partners at Hikma were ordered to run another trial for their knockoff of GSK’s Advair before they would consider it for marketing approval.
“The study outcome is disappointing, however the primary endpoint in this difficult-to-treat patient population presented a high hurdle from the outset,” noted Tim Harrison, a professor at the University of Nottingham and the principal investigator in the trial. “Whether there is a specific severe asthma phenotype who could gain greater benefit remains a distinct possibility. I believe the technology behind VR475 has the potential to be beneficial in the treatment of a wide range of respiratory diseases including asthma.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,300+ biopharma pros who read Endpoints News by email every day.Free Subscription