The News

Neuro3d Reports Positive Results from Phase II Trials of Ocaperidone in Schizophrenia

12/04/2005

Mulhouse, April 12, 2005 - Neuro3d, a drug discovery and development company for psychiatric disorders, announced today preliminary positive results from two international, double-blind, randomized studies showing that ocaperidone exhibits a robust antipsychotic activity in schizophrenia patients. The effects were found to be significantly better than placebo and comparable to that of an approved atypical antipsychotic agent. No serious adverse events attributable to ocaperidone were seen and patients experienced significantly less weight gain with ocaperidone than with the reference compound. Weight gain is a risk for some of the new antipsychotic medications.

“We are extremely encouraged by the consistent improvement in all efficacy measures (PANSS, BPRS and CGI) in both Phase II studies with ocaperidone. By demonstrating superior efficacy over placebo and comparable efficacy to a well established antipsychotic, but with a good side effect profile, in particular less weight gain, ocaperidone fulfilled our expectations based on our earlier results,” noted Charles Woler, CEO of Neuro3d. “These data will form the basis of larger scale, Phase III trials, where the effects of ocaperidone can be evaluated further. We believe that ocaperidone has the potential to provide an effective and well tolerated treatment option for schizophrenia patients.”

The Phase II studies consisted of two international randomized clinical trials.  OCA-05 was an eight week,  double-blind, placebo-controlled study with 127 patients to demonstrate therapeutic efficacy of ocaperidone at 0.1 – 0.6 mg per day  vs. placebo. The main objective of the second study, OCA-06, with 105 patients and 12 weeks treatment duration, was to compare ocaperidone at doses of 0.1 - 0.6 mg per day against a standard atypical antipsychotic compound, with particular emphasis on safety and tolerability, especially weight gain. The schizophrenic patients had a mean total PANSS of higher than 100 at baseline after washout of preceding antipsychotic medication. Efficacy was measured using standard indicators, including PANSS and composite score, BPRS and CGI scores that determine the severity of disease with regards to the positive (e.g. hallucinations) or negative symptoms (e.g. social withdrawal, emotional flatness).

In both studies, large improvements from baseline were seen in all primary efficacy measures. Significant improvements were observed in all PANSS subscores, (negative, positive and general) in the ocaperidone treated group compared to placebo. Similarly, a large improvement in BPRS and CGI scores vs. baseline was observed.

No change in mean weight gain was seen in patients receiving ocaperidone in the placebo-controlled trial, OCA-05. In the OCA-6 study weight gain was statistically significant higher in patients treated with the reference compound. There were no serious adverse effects and no cardiovascular events observed with ocaperidone. Some incidence of common adverse events for atypical antipsychotics such as extrapyramidal side effects were observed.

About Ocaperidone
Ocaperidone is an atypical antipsychotic drug. Studies with healthy volunteers showed that the repeated administration of low doses of ocaperidone quickly led to strong and long-lasting CNS effects as reflected by changes in the EEG. Data collated so far indicate that ocaperidone is a promising potent antipsychotic without cardiovascular or weight gain problems. Neuro3d in-licensed ocaperidone from Janssen Pharmaceuticals in 2002.

About Schizophrenia
Schizophrenia, a seriously debilitating, chronic mental illness, affects approximately one in every 100 individuals or about 40 to 60 million people worldwide. It is characterized by distortions of reality and disturbances in perception, mood, cognition, motivation, social function and motor behavior. The cause of schizophrenia is unknown, but it usually strikes in early adulthood and often continues for the rest of the person’s life. Schizophrenia also causes changes in cognition that affect memory and general motivation. Often individuals become depressed and socially withdrawn. Although global sales of antipsychotics were over billion in 2003 and growing strongly, there is still a large unmet need for effective drugs with less side effects such as weight gain or sedation. 

About Neuro3d
Neuro3d SA is a biopharmaceutical company focused on discovery and development of innovative treatments for psychiatric disorders such as schizophrenia, depression and anxiety. Besides ocaperidone, Neuro3d’s clinical drug portfolio consists of ND1251, a PDE-4 inhibitor for the treatment of depression and ND7001, a new type psychoactive drug with antidepressant-like and anxiolytic effects in animals. Neuro3d also has additional compounds with new mechanisms of action that have the potential to overcome the limitations of current drug therapies at various stages or preclinical research. The company was founded in November 2000 and currently has 32 employees. Neuro3d is located in Mulhouse, France. 

Contacts

Neuro3d                 
Lubor Gaal         
Head of Business Development and Licensing     
Tel:     +33 (0)3 89 36 91 77       
Fax:     +33 (0)3 89 36 91 78       
Mobile: +33 (0)6 71 37 82 99       
lgaal@neuro3d.fr

Halsin Partners
Mike Sinclair
Director
Tel:     +44 (0)870 747 0880
Mobile: +44 (0)7968 022075
msinclair@halsin.com