Signage on the AstraZeneca facility in Gaithersburg, Maryland, US, on Monday, Aug. 26, 2024.
Graeme Sloan | Bloomberg | Getty Images
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The race to develop more convenient versions of medication that lower cholesterol is heating up after AstraZeneca released encouraging latest data on an experimental pill.
AstraZeneca and Merck are the important drugmakers testing oral versions of so-called PCSK9 Inhibitors, which reduce levels of low-density lipoprotein (LDL) cholesterol, or what’s generally known as “bad” cholesterol. Those medications, similar to Amgen’s Repatha, are typically injections.
High LDL cholesterol is the highest driver of cardiovascular events similar to heart attacks and strokes. Still, greater than 70% of patients taking statins aren’t reaching the goal level for cholesterol, in accordance with Mina Makar, who heads AstraZeneca’s global cardiovascular, renal and metabolism biopharmaceuticals business.
He said that results in 4 million to five million deaths worldwide on account of elevated cholesterol. While PCSK9 injections have helped treatment reach more patients, their use has still been “very limited,” Makar said. That is on account of several aspects, similar to challenges related to cost and access and hesitancy amongst some cardiologists and first care physicians.
“That is why we’re really enthusiastic about our oral PCSK9,” Makar said. “I believe it has the possibility to actually democratize access to what these patients actually need, which is something to get the vast majority of them” to their goal levels of cholesterol.
In a note last week, Goldman Sachs analysts said oral treatments could drive growth of the PCSK9 class to around $12 billion in sales by 2034, up from about $4 billion currently. The analysts expect AstraZeneca’s oral PCSK9 to be “well-placed in the category,” and so they forecast peak sales of the drug to be around $4 billion by 2037.
Now, let’s dive into the brand new mid-stage trial data. It was presented on the American College of Cardiology’s Annual Scientific Session in Chicago.
After 12 weeks, the experimental pill lowered LDL cholesterol by nearly 51% when taken once a day on top of an ordinary statin therapy, in accordance with AstraZeneca. The pill helped 84% of patients meet the really useful cholesterol level, in comparison with just 13% of those that took statins alone.
Patients within the trial tolerated the pill well, and antagonistic unwanted effects were comparable between those that took AstraZeneca’s drug and folks who received a placebo.
Those results show promise against Merck’s treatment, though it’s difficult to match data without head-to-head clinical trials. Merck’s oral PCSK9 can also be much further along in development, with late-stage trial data expected this yr.
Early data also suggests Merck’s drug could possibly be more practical than AstraZeneca’s treatment, in accordance with Goldman Sachs analysts. But they still see “significant opportunity” for AstraZeneca’s pill given the dimensions of the marketplace for PCSK9s and the “potential for differentiation on convenience.”
Merck’s drug is what’s generally known as a macrocyclic peptide, which requires patients to fast before taking it to permit for correct absorption. That “could possibly be burdensome and exacerbate compliance issues in an asymptomatic disease area where there’s reluctance to accentuate therapy,” the Goldman Sachs analysts wrote.
But AstraZeneca’s pill is a small-molecule drug, so it doesn’t have any food restrictions or fasting requirements.
Makar said one other advantage of getting a small molecule drug is that it is straightforward to mix with other therapies in the corporate’s pipeline. For instance, AstraZeneca is considering combining it with its statin, its GLP-1 drug for weight reduction or its treatment ezetimibe, which is a cholesterol medicine for patients who cannot tolerate statins, he said.
Merck has similarly discussed the potential of mixing its oral PCSK9 with other treatments, calling it a “pipeline in a product.”
We’ll proceed to follow the continued race to develop oral PCSK9s, so keep track of our coverage!
Be at liberty to send any suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health-care tech: FTC says 23andMe buyer should ‘expressly agree’ to stick to privacy policies
The Federal Trade Commission on Monday urged the embattled genetic testing company 23andMe to not sell consumers’ data unless the client agrees to stick to strict privacy and data security standards.
23andMe, which was once valued at $6 billion, filed for Chapter 11 bankruptcy protection in Missouri federal court last month. This implies its assets — including its vast genetic database — are up on the market.
“Any purchaser should expressly comply with be certain by and cling to the terms of 23andMe’s privacy policies and applicable law, including as to any changes it subsequently makes to those policies,” FTC Chairman Andrew Ferguson wrote in a letter.
The corporate rocketed into the mainstream due to its at-home DNA testing kits that gave customers insight into their family histories and genetic profiles. The five-time CNBC Disruptor 50 company went public in 2021 via a merger with a special purpose acquisition company, however it struggled to generate recurring revenue and rise up viable research and therapeutics businesses in subsequent years.
DNA data is especially sensitive because everyone’s sequence is exclusive, meaning it may possibly never be fully anonymized, in accordance with the National Human Genome Research Institute. If genetic data falls into the hands of bad actors, it could possibly be used to facilitate identity theft, insurance fraud or other crimes.
23andMe has repeatedly said it would not change the way it manages or protects consumer data throughout the sale process. Similarly, in a release last week, the corporate said all potential buyers must comply with comply with its privacy policy and applicable law.
“To constitute a certified bid, potential buyers must, amongst other requirements, comply with comply with 23andMe’s consumer privacy policy and all applicable laws with respect to the treatment of customer data,” 23andMe said in the discharge.
At this point, it isn’t clear who will purchase 23andMe’s assets. Anne Wojcicki, who resigned as CEO last month, said in a post on X that she’s going to pursue the corporate as an independent bidder. Wojcicki co-founded 23andMe in 2006, and he or she has submitted several unsuccessful proposals to take the corporate private over the past yr.
All of Wojcicki’s offers have been rejected by 23andMe’s special committee, which was convened in March of 2024 to judge the corporate’s path forward.
If you ought to find out how you may delete your data from 23andMe, you may read more here.
Be at liberty to send any suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
