Memory Pharmaceuticals is currently conducting a Phase II trial of R3487/MEM 3454 in cognitive impairment associated with schizophrenia (CIAS), and the companies have agreed to expand the study to allow for an increase in the target number of patients enrolled in the trial to up to approximately 212 patients, which will provide for a more robust data set and increase the potential for the study to facilitate advancing the compound into a pivotal trial.
Under the terms of the amendment, Roche will provide funding to Memory Pharmaceuticals, in advance, for all costs associated with the increase in enrollment and will accelerate a portion of the $17 million payment associated with the completion of the Phase II CIAS trial as follows – $3.5 million in connection with entering into this amendment and $5 million upon the completion of enrollment for the CIAS trial.
The payment of the remaining $8.5 million will become due 30 days following the availability of top-line data from the Phase II CIAS trial, which is now expected in the second quarter of 2009.
The Phase II trial is in patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects in the study are randomized to receive 5mg, 15mg or 50mg of R3487/MEM 3454 or placebo once daily for a period of eight weeks.
The primary objective of the trial is to assess the effectiveness of R3487/MEM 3454 in CIAS using the Matrics consensus cognitive battery. Secondary objectives include measures of other symptoms of schizophrenia and functional capacity.
In addition, Roche has notified Memory Pharmaceuticals that it intends to initiate a Phase II trial of R3487/MEM 3454 in Alzheimer’s disease starting either at the end of this year or at the beginning of 2009.