Schizophrenia (RG1678), Multiple Sclerosis (Ocrelizumab) Drugs By Roche Enter Phase III Of Clinical Trials.I

Roche Holding AG (ROG.VX) Thursday announced that drugs slated to treat diseases like schizophrenia, and multiple sclerosis will enter phase III of clinical trails and may submit applications for as many as 10 new drugs by the end of 2013. Roche is the world's biggest cancer drug maker and is seeking new paths outside the oncology arena to mitigate the effects of recent development setbacks. Avastin, the company’s top seller, failed in studies in prostate, stomach and early colorectal cancer.

Start of phase III programs for potential breakthrough therapies in schizophrenia and multiple sclerosis

Schizophrenia

Positive phase II proof-of-concept data with RG1678 in patients with predominantly negative symptoms of schizophrenia were recently presented at an international medical meeting³. Based on these promising results, a global phase III program has been initiated which includes a total of six studies investigating RG1678 in combination with standard of care antipsychotic drugs in patients with either negative symptoms⁴ or residual positive symptoms of schizophrenia⁵. Running the studies for both indications in parallel will allow a better understanding of the effect of RG1678 on a broad spectrum of symptoms and its value in the management of patients at different phases of their disease. The first patient was randomized into the phase III program in November 2010.

RG1678 is an investigational first-in-class glycine reuptake inhibitor that normalizes glutamate neurotransmission, thereby targeting an important pathway in the treatment of psychiatric disorders. By normalising glutamate neurotransmission in the brain, RG1678’s unique mode of action could also have valuable therapeutic applications in other psychiatric indications beyond schizophrenia.

Multiple sclerosis

Ocrelizumab, a humanized anti-CD20 antibody administered as a six-monthly infusion, demonstrated a highly significant reduction in disease activity as measured by brain lesions (96% for 2000mg and 89% for 600mg ocrelizumab dosing regimens) and relapse rate (73% for 2000mg and 80% for 600mg ocrelizumab at week 24) compared to placebo in a phase II study in relapsing-remitting multiple sclerosis (RRMS). The efficacy data, amongst the highest seen in a phase II RRMS study, were recently reported at the ECTRIMS conference. Based on these results, ocrelizumab will move into phase III studies in multiple sclerosis. Two studies will explore ocrelizumab’s efficacy in RRMS head-to-head versus interferon, the current standard of care, and one study will investigate the potential of ocrelizumab in patients with primary-progressive multiple sclerosis (PPMS).  Phase III studies for ocrelizumab will commence in the first quarter of 2011.

 Press Release by Roche