Following disappointing results from two Phase II EMPOWER trials, AbbVie is recalibrating its strategy for emraclidine, a once-daily, oral drug candidate initially investigated as a monotherapy for schizophrenia. The trials failed to demonstrate a statistically significant reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week 6, the primary endpoint.
The setback has led AbbVie to take a $3.5 billion impairment charge related to the emraclidine intangible asset, acquired as part of the $8.7 billion acquisition of Cerevel Therapeutics in December 2023. Robert Michael, AbbVie's CEO, acknowledged the challenges but expressed optimism about other assets from the Cerevel acquisition, particularly tavapadon for Parkinson's disease.
Revised Development Strategy
Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, outlined a revised development path for emraclidine. The company will now focus on evaluating emraclidine as an adjunctive treatment to existing therapies for schizophrenia and as a monotherapy for psychosis associated with Alzheimer's and Parkinson's diseases.
Thakkar noted that further analysis of the Phase II data revealed a potential efficacy signal when excluding sites with high placebo response rates. "When assessing sites beyond those with high placebo response, a clear efficacy signal was observed, albeit more modest than reported in Phase Ib, therefore we see a path forward as an adjunct to atypicals in schizophrenia and as a monotherapy in psychosis related to Alzheimer’s and Parkinson’s."
Future Clinical Trials
AbbVie plans to initiate a multiple ascending dose study this year, with data expected in early 2026, to assess the potential of higher doses of emraclidine. If the higher doses demonstrate improved efficacy, the company may reconsider pursuing emraclidine as a monotherapy for schizophrenia. Additionally, Phase II trials in Alzheimer's and Parkinson's disease psychosis are planned for 2026.
Financial Performance
Despite the emraclidine setback, AbbVie reported strong fourth-quarter and full-year 2024 financial results. Sales of Skyrizi and Rinvoq continue to drive revenue growth, offsetting declining Humira sales due to biosimilar competition. The neuroscience portfolio, which includes treatments for neurological and psychiatric disorders, saw a 16.6% increase in sales compared to the previous year, reaching approximately $9 billion.
AbbVie's total revenue for the fourth quarter was $15.1 billion, exceeding analysts' expectations. Full-year revenue reached $56.334 billion, a 3.7% increase compared to the prior year. William Blair’s analysts noted that AbbVie continues to have one of the strongest revenue growth outlooks in the biopharmaceutical industry, primarily driven by Skyrizi and Rinvoq.
