Eli Lilly will pay AC Immune CHF 30 million ($30.2 million) in the first milestone payment tied to the companies’ CHF 1.89 billion ($1.9 billion) collaboration launched in December to develop new treatments for Alzheimer’s disease and other neurodegenerative disorders, the Swiss biotech said today.
AC Immune said it will receive the milestone payment on or before October 7, 2019, in “a recognition of progress in the collaboration between the two companies”—namely the launch in July of a Phase I trial of ACI-3024, the company’s lead tau aggregation inhibitor small molecule candidate.
The Phase I trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy volunteers, AC Immune said, through a randomized, placebo-controlled, double-blind, sequential single and multiple ascending dose study with open-label food effect and pharmacodynamics assessment arms.
“The start of the ACI-3024 Phase I study, represents an important advancement in the broader effort we are making and further expands our robust clinical pipeline to address neurodegenerative diseases, in particular for therapeutics and diagnostics targeting Tau,” AC Immune CEO Andrea Pfeifer said in a statement.
ACI-3024 is a first-in-class investigational oral small molecule Tau Morphomer™ candidate in development for treatment of Alzheimer’s disease and other neurodegenerative disorders. ACI-3024 is the primary focus of the collaboration with Lilly, launched in December 2018 to research and develop tau aggregation inhibitor small molecule using AC Immune’s Morphomer platform.
Under their agreement, AC Immune agreed to conduct the initial Phase I development of the Morphomer tau aggregation inhibitors, while Lilly agreed to fund and conduct additional research and further clinical development.
AC Immune has said that ACI-3024 has shown tau aggregation inhibition in preclinical models. At the Jefferies Healthcare Conference in November 2018, Pfeifer presented data showing a significant inverse correlation between cerebrospinal fluid levels of tau and ACI-3024 exposure in plasma—which “might indicate an increase of tau clearance from the brain.”
The milestone payment is half of the CHF 60 million ($60.4 million) in near-term milestone payments Lilly agreed to pay AC Immune under the collaboration. The other CHF 30 million milestone payment is scheduled in the first quarter of 2020, tied to achieving additional development milestones, AC Immune said.