AstraZeneca's Next-Generation Aldosterone Synthase Inhibitor Baxdrostat Granted Clinical Trial Approval in China

On January 31, according to the CDE official website, AstraZeneca's Class 1 new drug Baxdrostat Tablets received clinical trial implied permission, intended for treating hypertensive patients whose blood pressure is poorly controlled by other medications, aiming to reduce blood pressure.

Source of the image: CDE official website

$1.8 billion
Accelerate the Layout of Cardiorenal Diseases

Baxdrostat (CIN-107), developed by CinCor Pharma, is a highly selective aldosterone synthase inhibitor (ASI) and represents a potentially leading next-generation ASI. In January 2023, AstraZeneca successfully acquired CinCor Pharma for $1.8 billion, incorporating its pipeline of novel drug candidates, including the lead product Baxdrostat.

Source of the image: Pharma Data Enterprise Edition - Global Drug Analysis System Database

According to relevant research, due to the 93% sequence similarity between aldosterone synthase and cortisol synthase, selective inhibition has always been difficult to achieve in the past. Baxdrostat, however, has successfully achieved this goal. While Baxdrostat lowers blood pressure by reducing aldosterone levels, it does not affect cortisol synthesis, thereby avoiding significant side effects.

In 2022, the results of the Phase II trial (BrigHtn) for Baxdrostat in patients with resistant hypertension were published in the NEJM, demonstrating that Baxdrostat significantly reduced blood pressure levels in these patients.

Image Source: NEJM Official Website

Currently, the phase III clinical study of Baxdrostat for hypertension is being advanced. In addition, the role of Baxdrostat in improving chronic kidney disease and primary aldosteronism is also under exploration.

Accelerate Pipeline Layout
Cardiovascular, Renal and Metabolic

According to AstraZeneca's Q3 2023 financial report, the revenue from its oncology drugs reached $13.458 billion in the first three quarters, accounting for 40% of the total revenue. The revenue from cardiovascular, renal, and metabolic drugs was $7.926 billion, making up 23% of the total revenue. In the field of cardiovascular, renal, and metabolic diseases, AstraZeneca has made comprehensive arrangements, with several drugs showing rapid research progress.

Image Source: AstraZeneca Official Website

Andexxa

Andexxa is a recombinant protein that binds with high affinity to both oral and injectable FXa inhibitors, rapidly reversing their anticoagulant effects. In 2018, Andexxa received its first FDA accelerated approval for market launch. This drug is understood to be the first treatment capable of specifically reversing the activity of FXa inhibitors and aiding in achieving hemostasis. In December 2023, Andexanet alfa was submitted for marketing approval in China.

Source of the image: CDE official website

Eplontersen

Eplontersen is a once-monthly ligand-conjugated antisense oligonucleotide drug that treats hereditary and non-hereditary amyloidosis polyneuropathy by reducing the production of serum TTR. In December 2023, Eplontersen received FDA approval for marketing to treat hereditary transthyretin-mediated amyloidosis polyneuropathy (ATTRv-PN), becoming the first ATTRv-PN treatment that can be self-administered via an autoinjector.

In addition, in AstraZeneca's cardiovascular, renal, and metabolic research pipeline, the AZD2693 injection for the treatment of NASH, the relaxin mimetic AZD3427, and other projects are also accelerating clinical research progress. Clinical trial applications have been submitted or clinical trials have been initiated in China.

Conclusion

Baxdrostat Tablets, as a potential leading next-generation ASI, have received approval for clinical trial applications in China. Based on their advanced clinical research progress overseas, they are expected to offer patients a broader range of antihypertensive options.

Editor: Mu Mian

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