BioArctic CEO Gunilla Osswald, PhD, called the decision disappointing but noted that phase 1 data are supportive of ABBV-0805’s progression to phase 2 and that the company would “investigate options to continue the development” of the α-synuclein antibody.
Gunilla Osswald, PhD
The Swedish-based biopharma company BioArctic AB has announced that its collaborative partner AbbVie has terminated its agreement regarding the portfolio of α-synuclein (α-syn) antibodies, including the humanized monoclonal antibody ABBV-0805 (previously known as BAN0805), which is in development for the treatment of Parkinson disease (PD).
Gunilla Osswald, PhD, CEO of BioArctic, called the decision disappointing in a statement.1 "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.
ArcticBio has also developed the PD1601 and PD1602 antibodies—which also target α-syn—for treatment of PD in conjunction with AbbVie. These agents are still in the discovery phase of development. The collaboration was established in 2016 to expand the research and development of BioArctic's portfolio of α-syn antibodies for PD, and potentially other indications.
A phase 1 study of ABBV-0805 (NCT04127695) was initiated in 2019, with results presented in September 2021 at the International Congress of Parkinson's Disease and Movement Disorders (MDS).2,3 The data from that first-in-human trial suggested that a single intravenous infusion of ABBV-0805 in healthy volunteers was well-tolerated without concerning safety findings related to adverse events, laboratory results, vital signs, or ECGs. These data, BioArctic noted, support a continuation into phase 2 with once-monthly dosing.1
Those preliminary data were suggestive of a favorable pharmacokinetic, pharmacodynamic, and immunogenicity profile for the therapy, and built upon what was shown in preclinical studies. The preclinical data suggested that in vivo, the murine version of ABBV-0805 (mAb47) displayed a significant dose-dependent decrease of α-syn aggregates in mouse model brains.4 Additionally, it resulted in significantly prolonged survival. Nordström et al, who published the data in 2021, wrote that “ABBV-0805 selectively targets soluble toxic α-synuclein aggregates with a picomolar affinity and demonstrates excellent in vivo efficacy.”
ArcticBio still has involvement with promising therapies in development through other partnerships, specifically lecanemab in the treatment of Alzheimer disease (AD), which it is developing in conjunction with Eisai. In March, data were presented at the 16th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Disorders (AD/PD). These new findings included findings on blood biomarkers of amyloid and p-tau from the phase 2b Study 201 (NCT01767311) in early AD, as well as preliminary results from the ongoing open-label extension study. The findings were supportive of lecanemab’s effect in AD.5
“Together, we continue to generate consistent data in support both for the science behind lecanemab and its biomarker and clinical effects in early AD, with continued low frequency of the side effect ARIA. It is truly encouraging to see how our partner Eisai wholeheartedly continues the development of lecanemab and now moves on with the subcutaneous formulation. Overall, the AD/PD conference 2022 showcases the great achievements being done within the field and we are looking forward to the key results coming later this year,” Osswald said at the time.5
AbbVie, on the other hand, recently presented 6-month interim results from a phase 3 open-label, single-arm study (NCT03781167) of another of its investigational therapies for PD, ABBV-951, a 24-hour/day subcutaneous foslevodopa/foscarbidopa formulation. The findings, presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington, showed significant reductions in motor complications and improvements in morning akinesia, sleep disturbances, and quality of life in patients with advanced PD. All told, ABBV-951 was also proven to be well-tolerated, with systemic and skin adverse events that were consistent with those of levodopa and other medications with subcutaneous delivery.6