Eisai and Biogen’s hopes of an early positive readout for anti-amyloid beta drug BAN2401 in Alzheimer’s disease (AD) have been crushed, but the companies refuse to give up on the program just yet.
The adaptive phase 2 trial in patients with mild or prodromal AD included a 12-month data readout, in which the two biotechs anticipated early signals of efficacy for the drug. Following an independent data monitoring committee’s reviewal of the results, early signs of efficacy were not detected.
Both companies stated the continuance to the pre-specified 18-month endpoint and that the early readout isn’t the end for the therapy. However, the failure brings the concerns that BAN2401 may follow in the same footsteps as most amyloid-targeted drug programs, failure. Biogen’s share price reflected concern among investors and it slid during after hour trading.
The study used the adaptive design for the purpose of seeing if it was possible to advance to phase 3 earlier, rather than with the standard phase 2 trial designs. The final data on clinical endpoints should be complete by the second half of next year.
“By using Bayesian statistics in this uniquely-designed trial we had hoped that it would enable us to demonstrate clinical success faster than more traditional study designs,” said Lynn Kramer, M.D., Eisai’s chief medical officer.
“We now await the final study analysis which will be conducted after 18 months of treatment, which represents an amount of treatment time that is considered as appropriate for assessing efficacy in disease modifying agents for Alzheimer’s disease.” The clinical endpoints will include cognitive and memory measures as well as biomarkers such as brain amyloid levels.
BAN2401 is one of the AD programs in Biogen and Eisai’s longstanding partnership along with BACE inhibitor elenbecestat (E2609), which last year progressed into phase 3 trials, and aducanumab which reported positive three-year data in a phase 1b study, and is presently in late-stage testing.