7th Oct 2025 08:40
(Alliance News) - AstraZeneca PLC on Tuesday said its therapy for hypertension demonstrated positive results in a recent phase 3 trial, while its breast cancer therapy is put forward for review in Japan.
The Cambridge, England-based pharmaceuticals company said the Bax24 phase 3 trial showed baxdrostat demonstrated a statistically significant and highly clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure compared with a placebo at 12 weeks.
Baxdrostat is intended for use with patients with treatment-resistant hypertension. It lowers blood pressure by inhibiting aldosterone, a hormone that raises blood pressure and increases the risk of heart and kidney problems.
Around 1.4 billion people around the world are living with hypertension, with around 50% of patients in the US on multiple treatments reporting not having their blood pressure under control.
The therapy's efficacy was observed throughout a 24-hour period. The company noted that multiple studies show 24-hour blood pressure is a more powerful predictor of cardiovascular events than a clinic-based measurement.
"This second phase III trial of baxdrostat shows substantial improvement in blood pressure, which reflects its durable half-life of up to 30 hours and highly selective inhibition of aldosterone synthase. Too many patients today have hypertension that remains hard-to-control throughout the day and night, making them especially vulnerable to cardiac events," said Sharon Barr, executive vice president, BioPharmaceuticals R&D at AstraZeneca.
"We are advancing our regulatory filings and rapidly progressing our robust clinical development programme for baxdrostat, as both a mono- and combination-therapy, across additional conditions where aldosterone plays a key role, including primary aldosteronism, chronic kidney disease and heart failure prevention."
Shares in AstraZeneca were down 0.2% at 12,706.00 pence in London on Tuesday morning. The stock has risen 7.6% over the past year.
Also on Tuesday, Tokyo-based pharmaceutical firm Daiichi Sankyo Co Ltd said it has submitted a supplemental new drug application to Japan's Ministry of Health, Labour & Welfare for Enhertu, or trastuzumab deruxtecan, in combination with pertuzumab for the treatment of patients with HER2 positive unresectable or recurrent breast cancer.
Enhertu has been jointly developed and commercialised by Daiichi Sankyo and AstraZeneca following a collaboration deal agreed in March 2019. It is a specifically engineered HER2 directed Dxd antibody drug conjugate.
The application was based on data from the recent Destiny-Breast09 phase 3 trial.
"In Destiny-Breast09, Enhertu plus pertuzumab demonstrated a median progression-free survival of more than three years, which represents an impressive improvement over the current standard of care," said Yuki Abe, head of the R&D division in Japan and head of research at Daiichi Sankyo.
"Following the recent approval of Enhertu in Japan for the treatment of HER2 low or HER2 ultralow metastatic breast cancer, this new submission of Enhertu plus pertuzumab for the first-line treatment of patients with HER2 positive disease underscores the commitment of Daiichi Sankyo to bring Enhertu to as many patients as possible in this region across certain subtypes of metastatic breast cancer."
Enhertu received breakthrough therapy designation from the US Food & Drug Administration in July, following which a supplemental biologics licence application was granted priority review in the U under the real-time oncology review programme.
Daiichi Sankyo shares closed up 2.5% at JPY4,001.00 in Tokyo on Tuesday, though the stock remains down 18% over the last year.
By Emily Parsons, Alliance News reporter
Comments and questions to [email protected]
Copyright 2025 Alliance News Ltd. All Rights Reserved.
Related Shares:
Astrazeneca