AbbVie shreds alpha-synuclein Parkinson's pact on cusp of phase 2, thinning field led by Roche

AbbVie is bowing out of the alpha-synuclein race. Having taken a drug candidate to the cusp of phase 2, AbbVie has terminated its collaboration with BioArctic, leaving a clutch of rivals such as Novartis and Roche to compete over the Parkinson’s disease opportunity.  

Alpha-synuclein has emerged as a popular target in Parkinson’s research, but the clinical evidence for the efficacy of molecules that address the misfolding of the protein is shaky. Biogen dropped its lead asset against the target after getting a look at phase 2 data. A phase 2 trial of Roche and Prothena’s challenger failed on the primary endpoint, but a closer look at the data persuaded the partners to push ahead.

BioArctic, the Swedish biotech that out-licensed ABBV-0805 to AbbVie, expected its partner to join the ranks of drug developers with alpha-synuclein candidates in phase 2 this year. However, AbbVie has now decided to pull the plug on its alpha-synuclein antibody rather than invest further in the program.

The news comes months after AbbVie presented data on ABBV-0805 in 44 healthy volunteers. Single intravenous infusions of the drug were well tolerated, and, with preliminary data suggesting a favorable pharmacokinetic, pharmacodynamic and immunogenicity profile, the researchers concluded the results supported moving into phase 2.

AbbVie ultimately opted against taking the candidate forward. BioArctic CEO Gunilla Osswald sees things differently, using the statement to disclose the termination to make the case for continued development of ABBV-0805 with once-monthly dosing.

“All available data indicates that ABBV-0805 has uniquely high selectivity for the pathological forms of aggregated alpha-synuclein, as well as Phase 1 data supporting progression to Phase 2. We believe that ABBV-0805 has the potential to become a disease-modifying treatment for people with Parkinson's disease and will now investigate options to continue the development of this asset,” Osswald said.

While AbbVie is pulling out, other drug developers have recently shown confidence in alpha-synuclein. Late last year, Novartis paid UCB $150 million upfront and committed to milestones that could hit $1.5 billion to co-develop a small-molecule inhibitor of alpha-synuclein misfolding. The Novartis agreement came months after AC Immune bagged Affiris’ alpha-synuclein-targeting portfolio in a $54 million deal. 

The interest in alpha-synuclein suggests BioArctic has a chance of finding a new partner for ABBV-0805, but investors responded negatively to the news, sending the biotech’s stock down 14% to 91 Swedish kroner ($9.60). AbbVie exercised its option on BioArctic’s Parkinson’s antibodies in 2018, paying a $50 million fee on top of the $80 million it had already handed over up to that point.