Lundbeck's experimental drug Lu AF35700 for treatment-resistant schizophrenia has failed a phase III trial.
The DAYBREAK trial was a multinational, double-blind, randomised, active-controlled phase III study that evaluated the antipsychotic efficacy, safety and tolerability of Lu AF35700 compared to an active-controlled arm over ten weeks in 964 patients with TRS. The trial did not meet the primary endpoint of statistical superiority vs conventional therapy.
Shares in the company fell 30% on the back of the news.
The drug was one of the company's few original experimental drugs close to reaching the market, and its failure could be a heavy blow as the company prepares to face generic competition for its best-selling treatment, the seizure medicine Onfi.
“TRS constitutes the highest burden of disease within schizophrenia for patients, their families and society and we had with Lu AF35700 hoped to show superiority against conventional therapy," said Anders Gersel Pedersen, Executive Vice President, Research and Development at Lundbeck. “This is a setback for patients with schizophrenia, but we will continue to advance our pipeline of innovative therapies to meet the needs of patients suffering from psychiatric and neurological diseases.”