AstraZeneca has reported positive outcomes from the BaxHTN Phase III trial, indicating that the highly selective aldosterone synthase inhibitor (ASI), baxdrostat, significantly reduced the mean seated systolic blood pressure (SBP), compared to a placebo, after 12 weeks.
The comprehensive, randomised, multi-centre, double-blinded, parallel group, placebo-controlled study also met all secondary endpoints.
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It aimed to assess the tolerability, effect, and safety of the therapy in patients currently taking two different antihypertensive medications, and those with resistant hypertension on three or more medications, including a diuretic.
The data from the trial will be shared with regulatory bodies globally and presented in a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress next month.
The BaxHTN Phase III trial was structured with three components to support its endpoints.
Its primary goal was evaluated over a 12-week double-blind, placebo-controlled period, involving 796 subjects randomised equally and given either 2mg or 1mg of the therapy, or a placebo, daily.
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By GlobalDataThe primary efficacy endpoint focused on the difference in the mean change from baseline in seated SBP at week 12 between the therapy and placebo groups.
The trial included a randomised withdrawal period from week 24 to week 32 to assess baxdrostat’s continued efficacy.
Approximately 300 subjects who received 2mg of the therapy were re-randomised to continue with the same dose or switch to a placebo for eight weeks, with SBP comparisons made at the end of this period.
Long-term safety and additional secondary endpoints were also evaluated, including the impact of baxdrostat on seated SBP and diastolic blood pressure at week 12, the proportion of participants achieving SBP below 130mmHg, and the occurrence of adverse events.
AstraZeneca BioPharmaceuticals research and development executive vice-president Sharon Barr said: “These findings provide compelling evidence of baxdrostat’s potential to address a critical unmet need by targeting aldosterone dysregulation, bringing a novel mechanism to a field that has seen little innovation in over two decades.”
In February 2023, AstraZeneca incorporated the therapy into its portfolio with the acquisition of CinCor Pharma.
