AstraZeneca, a major pharmaceutical company, has recently expanded its cardiovascular drug portfolio by securing the rights to a promising new drug designed to combat dyslipidemia, a condition characterized by abnormal cholesterol levels. This deal involved an agreement with CSPC Pharmaceutical Group, based in Hong Kong, which could see AstraZeneca paying up to $1.92 billion in development and commercialization milestones on top of an upfront payment of $100 million. Additionally, CSPC will also earn royalties from future sales if the drug reaches the commercial market.
The drug in question, known as YS2302018, specifically targets lipoprotein (a) or Lp(a), a protein that plays a crucial role in transporting cholesterol through the bloodstream. Elevated levels of Lp(a) are linked to an increased risk of cardiovascular diseases, including coronary artery disease and stroke, as they can lead to the buildup of cholesterol in blood vessel walls. While existing drugs such as PCSK9 inhibitors (like Repatha from Amgen and Praluent from Regeneron) as well as Novartis’s siRNA therapy Leqvio have shown efficacy in reducing Lp(a) levels, they do so only indirectly by targeting different proteins involved in cholesterol regulation. These existing treatments also require administration via injection.
What sets YS2302018 apart is its oral formulation, providing a potentially simpler and more appealing option for patients. This feature positions AstraZeneca to compete directly with other leading pharmaceutical companies like Eli Lilly, who are also developing oral treatments for lowering Lp(a). Notably, Eli Lilly’s muvalaplin has advanced to Phase 2 trials, highlighting the intensifying competition in this therapeutic area.
The pursuit of effective Lp(a) targeting drugs is not limited to AstraZeneca and Eli Lilly. Several other companies are making significant strides in this field. Amgen’s olpasiran and Silence Therapeutics’ zerlasiran are both undergoing Phase 3 trials, focusing on patients with atherosclerotic cardiovascular disease. Additionally, Ionis Pharmaceuticals’ pelacarsen, aimed at reducing Lp(a) production, is also in Phase 3 testing in collaboration with Novartis.
Moreover, Eli Lilly is exploring gene-editing therapies aimed at providing one-time treatments for cardiovascular diseases through an alliance with Verve Therapeutics, targeting not just Lp(a), but also PCSK9 and ANGPTL3.
AstraZeneca is optimistic about the potential of YS2302018 to serve not only as a standalone therapeutic but also in combination with other treatments. One such potential pairing could be with its own PCSK9 inhibitor, AZD0780. Initial studies have shown that AZD0780, when used with statin therapy, significantly reduces LDL cholesterol levels and is currently undergoing Phase 2 trials.
This strategy aligns with AstraZeneca’s broader objective of advancing innovative treatments that address significant unmet medical needs in cardiovascular care, as stated by Sharon Barr, the company’s executive vice president. This approach is crucial given that cardiovascular disease remains one of the leading causes of death globally.
The industry landscape for cardiovascular therapies is set to gain more clarity with upcoming presentations and data releases. Analysts like Myles Minter from William Blair have highlighted the different strategies that pharmaceutical companies, including Pfizer and Merck, are employing in combining Lp(a) and PCSK9 inhibition. Furthermore, the upcoming American Heart Association’s Scientific Sessions will feature important data presentations, such as Phase 2 results for Lilly’s muvalaplin, which will be critical in establishing the efficacy benchmark for oral Lp(a)-lowering therapies.
Despite the strong competition, treatments like zerlasiran remain attractive targets for partnerships or acquisitions, given their potent Lp(a)-lowering capabilities and favorable dosing schedules. Such dynamics underscore the ongoing interest and vigorous development activity in this therapeutic area, with significant implications for patient care and pharmaceutical strategy in the coming years.
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