Company: AZN
Filing Date: 2025-07-14
Form Type: 6-K
Source: 0001654954-25-008010
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-07-14
Form: 6-K
Chunk 2
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#### Notes

#### Hypertension that is hard to control
Hypertension is a medical condition characterised by consistently high blood pressure levels. 2,3 Over time, this can damage blood vessels and vital organs, increasing the risk of serious health problems. 2,3 Hypertension that is hard to control remains a significant public health challenge. 1 Despite lifestyle changes and the use of multiple medications, a significant majority of people with hypertension do not achieve their blood pressure goals. 1,4 Uncontrolled hypertension persists despite treatment with two or more medications, while resistant hypertension, a more severe form, remains elevated despite treatment with three or more medications. 2,4

A key contributor of hypertension that is hard to control is aldosterone, a hormone that increases blood pressure by promoting sodium and water retention. 5,6 Elevated aldosterone levels, along with factors like obesity, high salt intake and various genetic and secondary conditions, 14 are strongly linked to poor blood pressure control. If left untreated, the condition significantly increases the risk of heart attack, stroke and kidney decline. 2,3

#### BaxHTN trial
The BaxHTN Phase III trial 7 had three components to it that support the following endpoints: The primary endpoint was assessed during a 12-week double-blind, placebo-controlled period. A total of 796 patients were randomised in a 1:1:1 ratio to receive baxdrostat 2mg, 1mg or placebo once daily. The primary efficacy endpoint was the difference in mean change from baseline in seated SBP at Week 12 between participants treated with baxdrostat (2mg or 1mg separately) and participants treated with placebo. Persistence of efficacy was assessed during a randomised withdrawal period from week 24 to week 32. Approximately 300 patients treated with baxdrostat 2mg were re-randomised in a 2:1 ratio to either continue receiving baxdrostat 2mg or placebo for the 8 weeks. SBP at the end of the 8 weeks was compared with placebo and the baxdrostat 2mg dose. Long-term safety is assessed at the end of the 52 weeks compared to a standard of care arm.

Additional secondary endpoints include the effect of baxdrostat versus placebo on seated SBP at Week 12 in the resistant hypertension subpopulation, the effect of baxdrostat versus placebo on seated diastolic blood pressure at Week 12, participants achieving