Phase III results in SOFIA study of NPL-2008
18 February 2009 - Neuropharm Group, a speciality pharmaceutical company focused on neurodevelopmental disorders, announces that the Phase III SOFIA study of NPL-2008 in Autistic Disorder did not achieve its primary endpoint. NPL-2008, a novel formulation of fluoxetine, was generally well tolerated by patients and no serious adverse events were reported.
A total of 158 patients, aged between 5 and 17, were enrolled into the SOFIA study in which patients received either NPL-2008 or placebo during a 14 week treatment period. The primary endpoint of the study was the reduction in the CYBOCS-PDD measure of repetitive behaviours as analysed at the end of treatment.
The SOFIA study showed that repetitive behaviours were reduced after both NPL-2008 and placebo treatment, but the study did not meet its primary endpoint of demonstrating a statistically significant difference between the two groups. The full analysis of the primary and secondary data from the study is ongoing.
The SOFIA study was intended to expand on a published study conducted at Mount Sinai School of Medicine in New York, in which fluoxetine produced positive results in a Phase II crossover, single site trial in children and adolescents with Autistic Disorder. The SOFIA study was carried out in association with Autism Speaks' Autism Clinical Trials Network and involved 19 specialist sites across the US.
Neuropharm, whose pipeline includes NPL-2008 and three further compounds for neurodevelopmental disorders, intends to release its half year results in early March.
Robert Mansfield, Neuropharm's CEO, commented: "These initial results are both unexpected and disappointing, and we await the results of the full analysis which is currently ongoing. We would like to thank Autism Speaks' Autism Clinical Trials Network who facilitated the timely completion of this study and to thank the teams at the sites involved in SOFIA."
For further information please contact:
Neuropharm + 44 (0) 1372 371 171
Robert Mansfield, Chief Executive Officer
Dr Mike Snape, Chief Scientific Officer
Piper Jaffray Limited + 44 (0) 203 142 8700
Neil Mackison, Rupert Winckler
Buchanan Communications + 44 (0) 207 466 5000
Mark Court, Mary-Jane Johnson, Catherine Breen
Notes to Editors:
About Neuropharm
Neuropharm is a speciality pharmaceutical company focused on improving patient lives by delivering medicines for high unmet needs in the treatment and management of neurodevelopmental disorders. Please visit www.neuropharm.co.uk for further information.
About the SOFIA study
SOFIA (Study Of Fluoxetine In Autism) is the largest study ever conducted in Autistic Disorder. SOFIA was designed to study the effect of low dose NPL-2008 on repetitive behaviours as measured using the CYBOCS-PDD scale in children and adolescents with Autistic Disorder.
The study was modelled on, and intended to expand upon, a previous positive study conducted at Mount Sinai School of Medicine in New York. The protocol was determined after review with FDA including Special Protocol Assessment and Fast Track designation was subsequently granted following FDA's review of the programme. The study was carried out in association with Autism Speaks' Autism Clinical Trials Network and involved 19 specialist sites across the US.
Fluoxetine is currently approved for a number of uses. SOFIA is a study of repetitive behaviours in Autistic Disorder. Parents and carers should talk to their physicians for specific questions related to treatment.