Swedish biopharma company BioArctic AB (publ) (Nasdaq Stockholm:BIOA B) said on Monday that it expects to receive a milestone payment of EUR15m from its partner Eisai for the start of dosing of the first patient under its the global, single confirmatory Phase 3 study (Clarity AD) with BAN2401 in early Alzheimer´s disease.
Following this milestone payment, BioArctic will have received EUR62m so far from Eisai. BioArctic can receive upto EUR218m plus high single digit royalty payments.
Under the terms of the agreement, Eisai is responsible for the clinical development of BAN2401, including this confirmatory Phase 3 study and BioArctic is entitled to milestone payments and royalties.
The company stated that the Clarity AD is a global placebo-controlled, double-blind, parallel-group, randomised study in 1566 patients with early Alzheimer's disease. In the treatment group, BAN2401 will be administered at a dosage of 10 mg/kg twice a month. The primary endpoint is the change from baseline in the cognition and function scale Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment.
BAN2401 is a humanised monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai. BAN2401 has a unique binding profile and selectively binds to neutralize and eliminate soluble, toxic amyloid-beta aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in Alzheimer's disease. BAN2401 has the potential to have an effect on the disease pathology and to slow down the progression of the disease.
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