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Signage at the AstraZeneca facility in Gaithersburg, Maryland, US, on Monday, Aug. 26, 2024.
The competition to create more accessible formulations of cholesterol-lowering medications is gaining momentum with recent promising data from AstraZeneca on an experimental oral pill.
AstraZeneca and Merck are leading the charge in developing oral alternatives to PCSK9 inhibitors, medications that target the reduction of low-density lipoprotein (LDL) cholesterol, informally recognized as “bad” cholesterol. Current options, like Amgen’s Repatha, typically require injectable administration.
Elevated levels of LDL cholesterol are a significant contributor to cardiovascular issues, including heart attacks and strokes. According to Mina Makar, head of AstraZeneca’s global cardiovascular, renal, and metabolism biopharmaceutical division, over 70% of patients prescribed statins fail to achieve their cholesterol management targets, which results in an estimated 4 million to 5 million fatalities globally attributed to high cholesterol levels. Makar pointed out that while PCSK9 injections have widened access to treatment, their application remains limited, hindered by factors such as cost, availability, and hesitance from some healthcare professionals.
Makar expressed optimism about the new oral PCSK9, stating, “I think it has the chance to really democratize access to what these patients really need.” He emphasized its potential to help a significant portion of patients reach their cholesterol goals.
Goldman Sachs analysts forecast a considerable increase in the market for PCSK9 medications, estimating sales could soar to $12 billion by 2034, up from about $4 billion currently. AstraZeneca’s oral PCSK9 is anticipated to capture a substantial share, with projected peak sales around $4 billion by 2037.
The new mid-stage trial data presented at the American College of Cardiology’s Annual Scientific Session in Chicago revealed that after 12 weeks of treatment, the experimental pill resulted in a nearly 51% reduction in LDL cholesterol when combined with standard statin therapy. Remarkably, 84% of patients achieved the desired cholesterol level, compared to only 13% among those solely on statins.
Overall, the pill was well-tolerated, and adverse effects were on par with those experienced by participants receiving a placebo. These findings suggest favorable prospects in comparison to the treatment being developed by Merck, yet direct comparisons remain challenging without concurrent clinical trials. Significantly, Merck’s oral PCSK9 therapy is further along the development timeline, with late-stage results expected soon.
Initial evidence also hints that Merck’s offering may outperform AstraZeneca’s, although analysts still identify significant market opportunities for AstraZeneca based on its emphasis on convenience. Merck’s formulation, classified as a macrocyclic peptide, necessitates fasting prior to ingestion, which could complicate patient compliance in a landscape where there is often reluctance to escalate treatment for asymptomatic conditions.
In contrast, AstraZeneca’s pill is a small-molecule drug that imposes no dietary restrictions or fasting protocols. Makar added that this formulation could be easily integrated with other medications in their pipeline, including potential combinations with statins, GLP-1 drugs for weight management, or ezetimibe for patients unable to tolerate statins.
Merck has similarly considered the integration of its oral PCSK9 with other treatments, referring to it as a “pipeline in a product.”
The race to develop oral PCSK9 inhibitors is ongoing, and developments will be closely monitored as both companies advance their respective treatments.
Latest in health-care tech: FTC says 23andMe buyer should ‘expressly agree’ to adhere to privacy policies
The Federal Trade Commission (FTC) recently urged the beleaguered genetic testing firm 23andMe to refrain from selling consumer data unless the prospective buyer commits to strict privacy and data security standards.
After filing for Chapter 11 bankruptcy protection last month, which placed its assets—including a significant genetic database—up for sale, 23andMe has garnered attention regarding its data handling practices. Once valued at $6 billion, the company experienced a challenging trajectory following a public merger in 2021.
FTC Chairman Andrew Ferguson emphasized in a letter that any buyer should be bound by 23andMe’s privacy policies and relevant laws, including any changes made to those policies. The company gained widespread recognition for its at-home DNA testing kits, allowing consumers to explore their ancestry and genetic makeup.
The sensitivity of DNA data cannot be overstated, as each individual’s genetic sequence is unique and thus cannot be adequately anonymized, raising significant risks associated with identity theft and insurance fraud if mismanaged.
23andMe reassured consumers that their data management practices will remain unchanged throughout the asset sale process, affirming that all potential buyers will need to agree to comply with their privacy commitments.
At this juncture, the identity of the potential purchaser for 23andMe’s assets remains uncertain. Former CEO Anne Wojcicki, who stepped down last month, has expressed intentions to bid independently, having previously made several proposals to reacquire the company privately, all of which have been declined by the appointed special committee evaluating the company’s future.
For those interested, additional information on how to delete personal data from 23andMe is available here.
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