Roche Holdings Ltd. (OTCQX:RHHBY) recently announced positive results from a mid-stage trial of its schizophrenia candidate, RG1678. The trial demonstrated that the candidate led to a reduction in the negative symptoms of schizophrenia, along with bringing about changes in patients’ personal and social functioning.
In the phase II trial, patients with predominantly negative symptoms of schizophrenia were given either RG1678 in combination with second-generation antipsychotics or placebo. The efficacy and safety profile of three dosage regimens of RG1678 (10 mg, 30 mg and 60 mg) were assessed in the study. The candidate as such was well tolerated with a favorable safety profile.
The candidate is currently in a phase III program for schizophrenia.
RG1678, once approved, will face competition from Johnson & Johnson’s (JNJ) Risperdal and Invega and Merck & Co. Inc.’s (MRK) Saphris. Forest Laboratories Inc. (FRX) also has a pipeline candidate for the treatment of schizophrenia in cariprazine.
Schizophrenia is a psychological disorder, characterized by disruptions in thinking and behavior, leading to hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, accompanied with social or occupational dysfunction. According to the World Health Organization (WHO), schizophrenia affects about 24 million people worldwide, particularly adults aged between 15 and 35 years.
The positive trial results of RG1678 come as a respite for Roche, which had been trying to cope with a number of pipeline debacles. These include the negative results on Avastin in gastric and prostate cancer patients, discontinuation of development of ocrelizumab for rheumatoid arthritis due to an unfavorable risk-benefit profile and a delay in the development of type II diabetes treatment, taspoglutide, due to a higher incidence of hypersensitivity reactions in late-stage trials.