BioArctic, a Company in Karolinska Development's Portfolio, Announces That the Phase IIb Study of BAN2401 in Early Alzheimer's Disease Continues Toward 18-Month Endpoint
STOCKHOLM, December 21, 2017. Karolinska Development announces today that BioArctic's drug candidate BAN2401 did not meet the criteria for success at a 12-month interim analysis of a Phase IIb study in patients with early Alzheimer's Disease (Study 201). Following the predefined study protocol, the blinded study will continue and a comprehensive final analysis of safety, tolerability and efficacy will be conducted at 18 months with the objective of demonstrating clinical efficacy of BAN2401. The results of the final analysis are expected to be obtained during the second half of 2018.
The 12-month interim analysis of this study utilizes an innovative Bayesian design with a high hurdle for crossing the success boundary. According to BioArctic, it is considered that 18-month treatment is a more appropriate assessment time to demonstrate efficacy of a disease modifying therapy for Alzheimer's Disease.
Study 201 is a placebo-controlled, double-blind, parallel-group, randomized study in 856 patients with prodromal or mild Alzheimer's Disease (collectively known as early Alzheimer's Disease) and with positive biomarkers for brain amyloid pathology.
The study design included 16 interim analyses that assessed potential for futility or stopping for safety. The study has passed all interim analyses since it met the criteria for continuation and the study continues to a full analysis at 18 months.
The efficacy of five dose groups of BAN2401 was evaluated at 12 months based on Eisai's in-house developed novel endpoint Alzheimer's Disease Composite Score (ADCOMS). According to the Bayesian analysis at 12 months, success was judged as an 80% or higher probability of having efficacy expected to correspond to a 25% or greater reduction in the rate of decline of ADCOMS by BAN2401 compared to placebo.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: firstname.lastname@example.org
Fredrik Järrsten, CFO, Karolinska Development AB
Phone: +46 70 496 46 28, e-mail: email@example.com