AbbVie is discontinuing solo development of a midstage Alzheimer’s disease candidate, a monoclonal antibody that failed to differentiate itself against already approved treatments.
Dubbed ABBV-916, the investigational immunotherapy is still listed in the pharma’s pipeline. However, the company is ending development of the asset as a monotherapy, AbbVie EVP of R&D and Chief Scientific Officer Roopal Thakkar, M.D., said on a July 25 quarterly earnings call.
“We recently completed an interim analysis of a phase 2 study evaluating ABBV-916, our Aβ antibody,” Thakkar said. “The emerging efficacy and safety profile in this study is similar to what has been demonstrated by approved agents. However, given the evolving landscape, we do not believe 916 as a monotherapy treatment will be sufficiently differentiated from other emerging therapies. As a result, we are discontinuing further development for 916 as a standalone antibody.”
ABBV-916 entered clinical testing back in 2022 in a phase 1/2 turned phase 2 trial that was recruiting as of June 7, according to ClinicalTrials.gov. The trial was set up to assess the mAb’s safety and efficacy for treating early Alzheimer’s among an expected 195 participants. The two-stage study included a multiple ascending dose portion as well as a proof-of-concept sect.
The trial has a completion date slated for 2031, according to ClinicalTrials.gov.
"AbbVie recognizes the significant contribution patients make by participating in our clinical trials and is committed to providing continued treatment with our investigational treatments to participants in our clinical trials based on different considerations," a company spokesperson told Fierce Biotech in an emailed statement. "Following determination of the appropriate medical treatment by the investigator, we will work closely with investigators to discuss all circumstances unique to individual patient needs."
The pharma is considering other options, including combination approaches, for the asset, according to the spokesperson.
ABBV-916 is designed to remove amyloid plaque, with a specificity like that of Eli Lilly’s donanemab, known commercially as Kisunla. Lilly’s anti-amyloid therapy scored approval for patients with early symptomatic Alzheimer’s at the beginning of this month.
Kisunla’s indication is nearly identical to the FDA-approved use of Eisai and Biogen’s Leqembi, which nabbed a full nod in July 2023. Both drugs need confirmation of amyloid beta pathology in patients' brain tissue before starting treatment, and both include a boxed warning on the risk of amyloid-related imaging abnormalities—known side effects of these antibodies.
However, Lilly touts Kisunla as the first anti-amyloid drug that allows patients to stop therapy when amyloid plaques are removed, enabling fewer infusions and lower treatment costs.
While AbbVie has abandoned this Alzheimer’s program, the pharma still has a heavy hand in neuroscience, with the $8.7 billion acquisition of Cerevel Therapeutics expected to close as soon as next week, newly appointed CEO Rob Michael said on today’s earnings call.
A star of Cerevel’s pipeline is emraclidine, a muscarinic M4 selective positive allosteric modulator being tested in schizophrenia and Alzheimer’s psychosis. No divestments related to the acquisition are expected, Michael said during the Q&A portion of the call.
As for overall pipeline strategy, the CEO said the company intends to keep adding on assets, especially via early-stage deals.
“We have a clear line of sight to top tier growth this decade, we want to position the company to deliver strong growth in the next decade as well,” Michael explained.