For an exclusive license to the preclinical Lp(a) disruptor, AstraZeneca is paying CSPC Pharmaceutical Group $100 million upfront and offering up to $1.92 billion in regulatory and commercial milestones.
AstraZeneca on Monday entered into an exclusive licensing deal with China-based CSPC Pharmaceutical Group to develop a preclinical lipid-lowering drug candidate, aiming to provide additional therapeutic benefits to patients with dyslipidemia.
Under the terms of the agreement, AstraZeneca will pay $100 million upfront and pledge up to $1.92 billion in development and commercialization milestones. CSPC will also be entitled to tiered royalties if the molecule reaches the market.
In return, AstraZeneca gains the right to advance YS2302018, an investigational oral small molecule disruptor of lipoprotein (a) (Lp(a)) that has been shown to effectively prevent its formulation, according to Monday’s press announcement. The pharma aims to develop the drug candidate, either alone or with its own experimental PCSK9 blocker AZD0780, for a variety of cardiovascular diseases.
Sharon Barr, head of BioPharmaceuticals R&D at AstraZeneca, in a statement called CSPC’s Lp(a) blocker an “important addition” to the company’s cardiovascular pipeline, adding that YS2302018 can potentially “help patients to more effectively manage their dyslipidemia and related cardiometabolic diseases.”
Lp(a) is a type of low-density lipoprotein (LDL) cholesterol characterized by an apolipoprotein(a) covalently bound to an apolipoprotein(B) molecule. High Lp(a) levels are associated with higher risks of heart attack and stroke, especially in patients with relevant medical histories, according to the Centers for Disease Control and Prevention (CDC).
Currently, treatment levels for high Lp(a) are “limited,” as per the CDC, which lists apheresis as the only FDA-approved intervention. Exercise and a healthy lifestyle cannot directly lower Lp(a), but they are effective in controlling LDL-cholesterol concentrations, which in turn could help prevent cardiovascular diseases.
With Monday’s CSPC deal, AstraZeneca joins Eli Lilly in the Lp(a) arena. In August 2023, the Indiana-based pharma released Phase I data for muvalaplin—which, like YS2302018, is an investigational oral Lp(a) inhibitor—demonstrating 63% to 65% maximum placebo-adjusted reductions in Lp(a). More than 90% of muvalaplin-treated participants reached Lp(a) levels lower than 50 mg/dL.
Lilly has moved muvalaplin into Phase II development for cardiovascular diseases.
Aside from muvalaplin, Lilly is also working on lepodisiran, an investigational siRNA therapeutic designed to silence the LPA gene, which encodes for Lp(a). According to the pharma’s pipeline webpage, lepodisiran is being developed for atherosclerotic cardiovascular disease.
Also in the Lp(a) arena, Novartis and Ionis have partnered to advance the potentially first-in-class antisense therapy pelacarsen, which lowers circulating Lp(a) levels by suppressing the production of apolipoprotein(a) in the liver. Pelacarsen is currently in late-stage development for the secondary prevention of cardiovascular events in patients with high Lp(a).
