As Biogen hopes and prays for a (now delayed) FDA approval of its controversial Alzheimer’s disease hopeful aducanumab, a key, closely watched pipeline asset has failed and been tossed out.
Buried in its annual results (PDF) published Wednesday morning, Biogen said the phase 2 study of BIIB054 (cinpanemab) in Parkinson’s disease “did not achieve proof-of-concept” and missed its primary and secondary endpoints
Biogen said it has now discontinued development of the drug and “will apply learnings to future efforts in Parkinson’s disease.”
As part of that cull, the pharma took a GAAP impairment charge of around $75 million during the fourth quarter.
Cinpanemab, which works as an anti-alpha synuclein (syn) monoclonal antibody, was being studied in the midstage SPARK study, with its primary endpoint being MDS-UPDRS total score, a measure of impairment and disability, versus a dummy treatment.
It was looking to rival Roche and Prothena’s syn drug prasinezumab, although this too has been beset by setbacks as it recently failed to beat placebo on MDS-UPDRS total score, although it saw enough to continue on with development. This follows a string of experimental drug failures over the years in Parkinson's R&D.
The drug had been a key weapon in Biogen’s arsenal but now hits the scrap heap at a time when its full-year guidance rests, literally, on the approval of aducanumab, which was rejected by the FDA’s expert panel late last year.