Basel, 10 November 2009
Roche reports positive Phase II results with potential first-in-class treatment for the negative symptoms of schizophrenia
Roche (SIX: RO, ROG; OTCQX: RHHBY) today reports results from a 320 patient phase II proof-of-concept study with it’s investigational glycine transporter-1 inhibitor RG1678. The study showed that the compound improved both the negative symptoms and the personal and social functioning of patients with schizophrenia reaching statistical significance on primary and secondary endpoints.
There are currently no effective therapies available for the treatment of negative symptoms, a core clinical feature of schizophrenia. These symptoms include apathy, lack of pleasure, lack of emotion and poor social functioning. Clinically disabling in more than 50% of all patients with schizophrenia, negative symptoms represent an important unmet medical need, and are associated with a substantial socio-economic burden.
"We are greatly encouraged by these clinical data with the novel glycine transporter-1 inhibitor RG1678" said Eugene Tierney, Head of the Central Nervous System Disease Biology Area at Roche. "Today’s therapeutic options fail to address these symptoms and also have many adverse side-effects. New treatment options harnessing novel modes of action such as RG1678 could offer relief to patients with this devastating disease and ease economic burden to society".
The analysis of this double blind phase II study showed that RG1678 has a robust and clinically meaningful effect in patients with schizophrenia. Improvements were observed on negative symptoms, overall physician’s assessment (clinical global impression) and patient’s personal and social performance in a prospectively defined intent to treat population. RG1678 was given as an add-on treatment to patients who were stable on antipsychotic therapy and suffered mainly from negative or disorganized thought symptoms. The compound was well tolerated at all doses tested.
Schizophrenia is a severe mental disorder, characterised by profound disruptions in thinking, affecting language, perception, and the sense of self1. According to World Health Organisation (WHO) estimates, the disorder affects approximately 24 million people worldwide and is most common in adults aged between 15 and 35 years. The symptoms of schizophrenia are broadly categorised as positive, negative, and cognitive symptoms. Positive symptoms are psychotic behaviours not seen in healthy people, such as hallucinations and delusions. Negative symptoms are associated with disruption to normal behaviour and emotion, such as a lack of ability to sustain planned activity or a lack of pleasure in everyday life. Cognitive symptoms include problems with working memory and trouble focusing or paying attention2. There is currently no marketed product available to treat the negative symptoms of the disease.
About RG1678 in schizophrenia
RG1678 is derived from Roche internal Research and is being co-developed globally with Chugai. The compound is a glycine transporter 1 inhibitor in development for the treatment of schizophrenia. RG1678 has the potential to enable patients to better establish social relationships and participate in functional activities, reducing the burden for caregivers and patients alike. It has been well-tolerated in studies to date, and combines efficacy with a benign safety and tolerability profile.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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1) Schizophrenia, World Health Organisation, http://www.who.int/topics/schizophrenia/en/
2) What are the symptoms of schizophrenia? National Institute of Mental Health, http://www.nimh.nih.gov/health/publications/schizophrenia/what-are-the-symptoms-of-schizophrenia.shtm