Last Tuesday, on January 21st, 2014, the Swiss pharmaceutical company Roche published a press release on the first results of two Phase III studies with its glycine transporter inhibitor bitopertin (RG-1678) in patients with schizophrenia. I already published on the potential of the compound in my post from April 19th, 2013.
In the Media Release it is stated:
“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that two phase III studies of its investigational medicine bitopertin (RG1678) in adults with persistent, predominant negative symptoms of schizophrenia failed to meet their primary endpoints, based on the negative symptoms factor score of the positive and negative symptom scale (PANSS). Negative symptoms include social withdrawal and lack of motivation.
In the studies, adding bitopertin to antipsychotic therapy did not significantly reduce negative symptoms at 24 weeks compared to placebo. Bitopertin was generally well tolerated and its overall safety profile was similar to that seen in the previously reported phase II trial (NN20372).”
A third study is still in progress. In three other studies bitopertin is tested against inadequately controlled positive symptoms. Results of these studies are not yet available. Click here for the full press release.
These results are disappointing, not only for Roche. They represent a setback for the entire field of psychiatry, which desperately waits for genuinely new drugs with innovative mechanisms of action. Especially drugs with activity against the negative symptoms of schizophrenia are urgently needed to improve the long-term outcome of schizophrenic disorders. The expectations that are being set in bitopertin are accordingly enormous. The reaction in the science- and business press was also huge.
We will now have to await the results of the four other studies. Above all, the precise data analyses, e.g., with regard to the secondary endpoints, have to be awaited.
This post is also available in: German