Top 5 Clinical Setbacks of 2014: Roche’s bitopertin.
Datamonitor Healthcare and SCRIP have paired up to select some of the biggest clinical study crashes to date this year. Today we will be focusing on the CNS space, where Roche was struck with a bit of bad luck when its first-in-class small-molecule GlyT1 inhibitor, bitopertin, failed in Phase III schizophrenia trials.
Roche released the results for two failed trials in January this year, both of which were testing bitopertin as a treatment for persistent, predominant negative symptoms of schizophrenia. Roche reported that adding bitopertin to antipsychotic therapy did not significantly reduce negative symptoms at 24 weeks compared with placebo, based on the negative symptoms factor score of the positive and negative symptom scale (PANSS).
Of all the CNS-focused late-stage failures this year – which include the Phase III failure of Shire’s Vyvanse as an adjunctive treatment for major depressive disorder in February – Datamonitor analyst Daniel Chancellor believes Roche’s product had the most potential. Mr Chancellor added that bitopertin “would have been unique in the market, both in terms of its mechanism and target patient population.”
Schizophrenia is characterized by three domains of symptoms: positive, negative and cognitive. The antipsychotics widely used for schizophrenia only really improve positive symptoms and they have little effect on negative symptoms and none on cognition. Despite the most common primary endpoint being the positive and negative symptom scale (PANSS) bitopertin was designed as a drug to improve negative symptoms, such as social withdrawal and lack of motivation. “As such, with no competition,” Mr Chancellor said, “Roche’s drug could have been used in all schizophrenia patients suffering negative symptoms, which is the vast majority.”
The Swiss drugmaker did release slightly more positive results in the second quarter, from the NIGHTLYTE study’s 10mg bitopertin arm, and said in July in its first half results presentation that further steps were under evaluation. . However, Roche is still testing the product in a Phase II obsessive-compulsive disorder trial.
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