Biogen/Eisai discontinue BACE inhbitor in Alzheimer’s
US-biotech Biogen and its Japanese partner Eisai have stopped two large Phase III studies of the investigational BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat/E2609 for Alzheimer’s disease, after an interim safety review highlighted an unfavourable risk-benefit ratio. The move effectively marks the end of development of agents in this putative drug class, following discontinations of similar mechanism programmes by Merck & Co (verubecastat), Novartis/Amgen (umibecestat/CNP520), AstraZeneca/Lilly (lanabecestat) and J&J (atabecestat) in the last couple of years for either lack of efficacy, safety or a combination of the two.
The move also marks a yet further diminuition of the industry development pipeline in Alzheimer’s, which has still yet to see the sucessful developlment of any disease-modifying therapy. Alzheimer’s proven extraordinarily intractible to drug development, something that is compounded by the fact clinical trials in the condition are extraordinarily expensive – such that it is now common for two pharma companies to combine efforts to reduce costs and/or mitigate risk. The move reduces the removes one of the few remaining Phase III stage programmes underway by large pharmaceutical companies or large cap biotechs. Roche continues to run a Phase III study of gantenerumab, and Amgen/Novartis have CAD106, an amyloid-beta immunotherapy, that is in a large pivotal trial.
Biogen and Eisai do still have one remaining Alzheimer’s programme in Phase III, the anti-amyloid beta protofibril monoclonal antibody BAN2401 and Biogen has three other mid-stage programmes; two anti-Tau MAbs (gosureanemab and BIIB-076) – the latter of which is included in its alliance with Eisai – and the Tau antisense oligonucleotide IONIS-MAPTRx, which is partnered with Ionis.
The news had a muted effect on Biogen’s share price, however, as investors had ascribed very little value to the programe, given the failure of competitors. Earlier this year, Biogen and Eisai terminated two large trials of another Alzheimer’s drug, aducanumab, after the failure of two large clinical trials. The results of these trials had previously been expected to be the largest data-driven binary events of 2019 for biotech investors, and indeed caused a lost of almonst 30% of Biogen’s stock price. biogen had been the top holding for Biotech Growth Trust (BIOG), but this ben sold since then.
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