Please login to the form below

Not currently logged in

Setback for Roche as schizophrenia candidate fails studies

 Bitopertin misses primary endpoints in two phase III trials


Prospects for Roche's candidate schizophrenia treatment bitopertin are looking shaky after the drug failed the first two of six planned phase III trials.

Bitopertin is the first in a new class of medicines known as glycine reuptake inhibitors and is being developed primarily to treat the negative symptoms of schizophrenia, such as social withdrawal and lack of motivation.

While so-called positive symptoms of schizophrenia such as hallucinations and delusions are fairly well-managed with existing anti-psychotic medicines, negative symptoms have proved a tougher challenge.  

Approximately two-thirds of schizophrenia patients experience significant negative symptoms, and it has been suggested that a drug able to control them could become a blockbuster product. Roche has also highlighted the drug as an important pipeline product.

The first two phase III studies to report focused on bitopertin's ability to treat adults with persistent, predominant negative symptoms of schizophrenia, but unfortunately giving bitopertin as an add-on to background antipsychotic therapy failed to meet the primary endpoint of a significant improvement on the positive and negative symptom scale (PANSS), said Roche.

A third phase III trial in patients with persistent negative symptoms is ongoing, with three more looking at the drug's role in patients who continue to have positive symptoms despite antipsychotic therapy.

Roche's chief medical officer Sandra Horning said the company would wait for the results of the remaining studies before taking a decision on the future of bitopertin, but acknowledged that the data is hugely disappointing for schizophrenia patients grappling with these debilitating symptoms.

The schizophrenia market has been shrinking in recent years as massively successful antipsychotic medicines such as Lilly's Zyprexa (olanzapine), AstraZeneca/Astellas' Seroquel (quetiapine) and Bristol-Myers Squibb/Otsuka Pharmaceutical's Abilify (aripiprazole) lost patent protection and succumbed to generic competition.

Meanwhile, pharma companies have struggled to bring novel antipsychotics to market, with Lilly dropping pomaglumetad methionil in 2012 and Targacept giving up on TC-5619 towards the end of last year. Like bitopertin both of these were being tested as add-on drugs to tackle negative symptoms, but had different mechanisms of action.

Analysts have suggested in the past that bitopertin could achieve sales of $3bn or more if it proves effective in managing withdrawal and lack of motivation in schizophrenia.

Article by
Phil Taylor

21st January 2014

From: Research



COVID-19 Updates and Daily News

Featured jobs


Add my company
Hanover Communications

Healthcare is evolving rapidly. To stand out from the crowd requires a potent combination of rich insight, innovative ideas and...

Latest intelligence

How innovating study sites can improve patient recruitment efficiency
There are so many ways that clinical trials have innovated over the last few years. There is now a larger focus on making trials more patient-centric, more virtualised, and more...
Avoiding A Series of Unfortunate Events: launch lessons from lockdown
Chris Ross takes a novel look at launch excellence through the lens of COVID-19 and explores how pharma’s launch leaders are rewriting the story...
6 reasons patients drop out of clinical trials and 6 ways to fix it
If you’ve successfully recruited patients for your clinical trial, but one by one, they begin to drop out, then this information could be for you....