Roche adds a slate of PhIII schizophrenia trial failures to bitopertin's obituary

Courtesy of Roche

A few months ago Roche ($RHHBY) put out the word that its schizophrenia drug bitopertin had flunked the first two Phase III studies in a lengthy lineup of clinical trials. And today the pharma giant almost completed its obituary for a drug program that had been touted as one of Roche's top blockbuster prospects, adding a long slate of trial flops to the record.

In its quarterly release out today, Roche said that a third Phase III study also failed its primary endpoint, adding that investigators decided to write off two more late-stage trials following a review of the outcomes they were seeing.

"Following these results, futility analyses were conducted on the three remaining Phase III bitopertin studies and Roche has decided to discontinue two of those studies and continue one study in sub-optimally controlled symptoms (NightLyte)," Roche reported.

Bitopertin--a glycine transporter-1 inhibitor--had tackled a tough set of endpoints. The initial studies were designed to test the treatment's ability to control negative symptoms of the disease, leaving investigators with the tricky task of tracking patients' improvement in areas like a lack of motivation and poor social skills. Roche has remained active in neurosciences even as rivals have cut back or exited the field in the face of repeated trial failures. 

Nevertheless analysts like Andrew Weiss at Switzerland's Bank Vontobel felt that the drug could earn more than $2 billion a year, targeting a large group of schizophrenic patients in need of additional help.

The failures mark a setback for Roche's pRED, the Basel-based operation that has been looking to mount a turnaround under John Reed. Reed in particular had highlighted bitopertin as one of Roche's top prospects in the neurosciences field. In addition to the failure in neuroscience, Roche also had to concede last month that its lung cancer drug MetMab flopped in Phase III, marking a setback for gRED, its big cancer drug R&D arm at Genentech.

Roche is switching its late-stage focus to oncoimmunotherapy. Its PD-L1 drug RG7446 moved into Phase III in the first quarter, trailing efforts by Bristol-Myers Squibb ($BMY) and Merck ($MRK) on the related PD-1 front. And Roche is also planning a Phase III trial for alectinib, another lung cancer drug for patients who are ALK-positive.

- here's the release (PDF)