AstraZeneca Initiates Phase III Clinical Trial of Next-Generation ASI Antihypertensive Baxdrostat in China

On March 22, AstraZeneca registered a Phase III clinical study on Baxdrostat tablets for the treatment of patients with hypertension on the Drug Clinical Trial Registration and Information Disclosure Platform. The drug received implied permission for clinical trials from the NMPA at the end of January this year.

Source of the image: Drug Clinical Trial Registration and Disclosure Platform

On the same day (March 22), the clinical trial application for Baxdrostat tablets combined with dapagliflozin to slow renal function decline in adult patients with chronic kidney disease and hypertension also received implied approval.

Source of the image: CDE official website

$1.8 Billion Introduced
Next-Generation ASI Antihypertensive Drugs

Excessive aldosterone can cause hypertension, particularly refractory hypertension. Therefore, drugs targeting aldosterone synthase can effectively control high blood pressure. However, due to the 93% sequence similarity between aldosterone synthase and cortisol synthase, achieving selective inhibition is challenging. Baxdrostat has successfully achieved this goal.

Baxdrostat (CIN-107) is a highly selective aldosterone synthase inhibitor (ASI) that can reduce blood pressure by lowering aldosterone levels without affecting cortisol synthesis, thereby avoiding significant side effects.

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

In 2023, AstraZeneca successfully acquired CinCor Pharma, the original research company of Baxdrostat, for $1.8 billion, while incorporating the drug into its R&D pipeline. According to relevant reports, Baxdrostat represents a potentially leading next-generation ASI. Currently, the overseas Phase III study of Baxdrostat for hypertension is being advanced, while its potential benefits for improving chronic kidney disease and primary aldosteronism are also under exploration.

AstraZeneca's recent clinical study registered on the Drug Clinical Trial Registration and Information Disclosure Platform is a double-blind, randomized, placebo-controlled, multicenter study (BaxAsia) to evaluate the efficacy and safety of Baxdrostat in Asian hypertensive subjects (including those with resistant hypertension) who have received two or more drug treatments and remain uncontrolled. The study is expected to enroll approximately 300 patients.

Source of the image: Drug Clinical Trial Registration and Publicity Platform

In addition, the clinical trial of Baxdrostat tablets combined with Dapagliflozin for patients with kidney disease has also received implied permission, which is expected to bring new options for such patients.

Global Layout Accelerates
Cardiovascular, Renal and Metabolic

In early February, AstraZeneca released its 2023 financial report, with total annual revenue of $45.811 billion (+3%), and total revenue excluding COVID-19 products was $45.488 billion. Among this, the second-largest segment, CVRM (Cardiovascular, Renal, and Metabolism Business Unit), achieved an annual income of $10.628 billion, a year-on-year increase of 15%. The blockbuster drug dapagliflozin contributed $5.963 billion (+36%) in revenue.

At the same time, AstraZeneca further accelerates the global CVRM business layout with rapid progress in multiple studies. Among them, the recombinant protein Andexxa was approved for clinical use in China in December 2023; in the same month, the monthly ligand-conjugated antisense oligonucleotide drug Eplontersen was approved for marketing by the FDA for the treatment of hereditary transthyretin-mediated amyloidosis polyneuropathy; projects such as the injectable AZD2693 for treating NASH and the relaxin mimetic AZD3427 have also applied for clinical trials or initiated clinical research in China.

Image Source: AstraZeneca

In addition, AstraZeneca is accelerating its layout in various therapeutic fields. On March 19, AstraZeneca announced the acquisition of Fusion, a nuclear medicine company, for an estimated total transaction value of approximately $2.4 billion. Fusion focuses on developing next-generation radiopharmaceutical conjugates. On February 22, AstraZeneca officially completed the acquisition of Gracell Biotechnologies, and a few days later announced that Shanghai had become its fifth global strategic center. Recently, Dato-DXd (developed and co-promoted by AstraZeneca and Daiichi Sankyo) was submitted for marketing authorization in China, and the EMA has also recently accepted the product’s marketing application.

Conclusion

The clinical trial of Baxdrostat tablets in China this time will be conducted among Asian subjects. Based on the foundation of overseas clinical research, as a potential leading next-generation ASI, the global market launch process of Baxdrostat is expected to accelerate.

Editor: Mu Mian

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