AbbVie has given Alpine Immune Sciences a way out of its delayed, over-budget phase 2 lupus trial. Under the revised deal, Alpine will stop the study early—and accept a significantly reduced option fee if AbbVie chooses to pick up the asset.
Alpine gave AbbVie an option on acazicolcept, a dual inhibitor of the CD28 and ICOS T-cell costimulatory pathways, in 2020 as part of a deal worth $60 million upfront. Investigators began enrolling 130 people with systemic lupus erythematosus in a phase 2 trial in June 2021. At that time, the aim was to complete the study in two years. The trial ended up taking longer—and costing more—than planned.
Having seen the study overrun, Alpine has amended its deal with AbbVie. Enrollment in the trial will stop within 30 days. Alpine will allow patients who join the trial before enrollment closes to complete dosing, putting it on track to complete the study by the end of 2024.
ClinicalTrials.gov has listed the study’s primary and full completion dates as November 2024 and January 2025, respectively, since August. As the timeline slipped from the original target, Alpine warned investors that “expenditures have exceeded our expectations” and that the “increased costs are expected to continue during the course of the phase 2 trial.”
The revised deal frees Alpine from the burdens of seeing the study through to its original enrollment goal but deprives it of potential future earnings. AbbVie will now pay $10 million, rather than $75 million, if it chooses to option the asset. Alpine also knocked 25% off the agreed milestones and royalties, reducing its potential development and commercial paydays to $153.75 million, at most.
Alpine agreed to the reductions after encountering issues that slowed the lupus trial. The biotech’s plan to open trial sites in Russia was ended by the war in Ukraine. Alpine took contingency measures but the enrollment rate lagged behind its goal, something it blamed on the intravenous route of administration, every other week dosing and available competing trials.
The biotech told investors enrollment delays may result in the expiration of previously manufactured lots of acazicolcept, forcing it to produce more of the study drug. Making more would add to costs and “could also contribute to additional delays if such lots are not qualified in a timely manner to avoid a pause in enrollment,” Alpine told investors in a financial filing.
As the acazicolcept study winds down, Alpine will be free to focus on the development of its wholly owned BAFF/APRIL antagonist povetacicept. The biotech plans to move the candidate, which is also a potential treatment for lupus, into “a broad development plan,” CEO Mitchell Gold, M.D., said in a statement.