AbbVie, Alpine Agree to End Phase II Lupus Trial Early and Slash Option Exercise Fee

AbbVie_Michael Vi/Adobe Stock

Pictured: AbbVie sign on a building/courtesy of Adobe Stock, Michael Vi

Alpine Immune Sciences has revised its agreement with AbbVie and will stop enrolling patients in a Phase II lupus study of the drug acazicolcept, the companies announced on Thursday.

According to the announcement, enrollment in the trial will end within 30 days. Still, patients who are already enrolled can finish the study, as well as patients in the screening process who meet the eligibility requirements. AbbVie will still hang on to the option to have an exclusive worldwide license to acazicolcept.

However, the option exercise fee priced at $75 million has been lowered to $10 million and the pre-option development milestone has been removed. So far, Alpine has received $105 million in total upfront and milestone payments in the deal. The company said that any potential future milestones related to sales and development have also been reduced by 25% from the original amounts.

“AbbVie has been a tremendous partner, and we appreciate their flexibility in amending our agreement to develop acazicolcept. While enrollment in the Synergy study will be stopped early by Alpine, we still anticipate that sufficient clinical and pharmacodynamic data will be available to enable a thorough evaluation of the study,” Alpine CEO Mitchell Gol said in a statement. “We plan to focus our development resources to advance [wholly owned BAFF/APRIL antagonist] povetacicept into a broad development plan.”

Acazicolcept is a dual inhibitor in the CD28 and ICOS T-cell pathways and works by blocking two costimulatory pathways to improve outcomes for patients with autoimmune and inflammatory diseases. According to ClinicalTrials.gov site, the study is estimated to be completed in early 2025.

In November 2023, Alpine touted some initial data for acazicolcept, stating that it suppressed the “expression of genes” associated with t-cell activation as well as reducing the “pathogenic hypergammaglobulinemia and glomerular IgG deposition” in mice with lupus.

AbbVie has also had its sights set on other modalities as it has made several billion-dollar deals in the past few weeks. In late November 2023, the company paid $10 billion to buy ImmunoGen and its antibody-drug conjugate to treat ovarian cancer. Early this month, AbbVie bought Cerevel for $8.7 billion, gaining access to medicines to treat psychiatric and neurological conditions.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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