On 15 November 2024 at the American Heart Association (AHA) conference in Chicago, Illinois, during a cardiovascular seminar session on the topic of emerging therapies for the treatment of hypertension and chronic kidney disease, Adina Turcu MD presented data on aldosterone synthase inhibitors (ASIs). Turcu focused on emerging selective ASIs: baxdrostat, lorundrostat, vicadrostat and dexfadrostat.
The ASI drug class potentially fills an unmet need in the chronic kidney disease (CKD) space as it has an alternative mechanism of action to currently marketed therapies. High aldosterone levels accelerate CKD progression. The data presented at AHA showed that primary and secondary aldosteronism are linked with higher cardiovascular, renal and metabolic risk in comparison to equivalent essential hypertension. In addition, ASIs have the potential to alleviate genomic and non-genomic aldosterone effects.
Combination therapies help to lower patients’ pill burden
In November 2023, Boehringer Ingelheim announced positive results from its Phase II trial. According to the trial, the use of BI 690517 (vicadrostat), on top of empagliflozin, resulted in a clinically meaningful reduction in urine albumin-creatinine ratio (≥30%), achieved by up to 70% of participants. Key opinion leaders interviewed by GlobalData have expressed much interest in combination therapies, emphasising that such therapies can help lower the pill burden of CKD patients.
CKD is a chronic condition in which patients suffer from an irreversible and progressive loss in renal function over many months or years, ultimately resulting in end-stage renal disease and the requirement for renal replacement therapy. The ageing global population will lead to an increase in the prevalence of CKD, leading to an expansion of the market as well as a growing need for more therapeutic options. However, the widespread use of generic CKD drugs continues to make it difficult for high-priced branded therapies to fully penetrate the market.
According to GlobalData’s Pharma Intelligence Center Drug Database, there are four aldosterone synthase inhibitors in development for CKD: AstraZeneca’s baxdrostat, Mineralys Therapeutics’ lorundrostat hydrobromide, Boehringer Ingelheim’s vicadrostat and Elicio Therapeutics’ small molecules to inhibit CYP11B2 for chronic kidney disease. Â
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