Baxdrostat

AstraZeneca’s pill baxdrostat looks likely to win approval in uncontrolled and treatment-resistant hypertension after succeeding in its pivotal trial. And the results validate the company’s 2023 buyout of CinCor Pharma, which originated the drug, for a $1.3 billion upfront. The UK pharma said Monday that patients who took baxdrostat once-daily for three months had a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure, compared with those given placebo. Both doses tested, 1 mg and 2 mg, hit that mark in the 796-patient study, which added baxdrostat to the standard of care. But the full data are still under wraps, making the pill’s commercial reach hard to quantify. The Phase 3 BaxHTN trial enrolled two different types of patient. First, those whose blood pressure remained high despite their taking at least two antihypertensive drugs, a condition known as uncontrolled hypertension. It also signed up patients who had hypertension despite taking three or more meds, including a diuretic. Known as resistant hypertension, those patients are harder to treat. The study also met all its secondary endpoints. According to the trial’s protocol , these include changes in as diastolic blood pressure as well as blood pressure in the resistant population specifically. The drug was generally well tolerated, AstraZeneca said, and it plans to file the results with regulators for approval. That will trigger a contingent value right of $10 per share in cash, for a total of $500 million, to former CinCor shareholders. Competition against Mineralys Baxdrostat is an aldosterone synthase inhibitor. Aldosterone is a hormone that can increase blood pressure, and therefore cardiovascular and renal risk, by boosting sodium and water retention. One key question — unanswered for now — is how the product stacks up against the other aldosterone synthase inhibitor to post Phase 3 data in the past few months: Mineralys’s loroundrostat. In loroundrostat’s pivotal study, a lower 50 mg per-day dose achieved a statistically significant placebo-adjusted blood pressure drop of 11.7 mmHg after three months’ treatment. But patients who had their doses titrated up to 100 mg per day had a lesser reduction of 8.4 mmHg, compared with placebo, though this was still significant. The results were considered approvable by stock analysts, and could position lorundrostat as a fourth-line hypertension therapy. So AstraZeneca will want to do as well or better to give baxdrostat a shot at outcompeting Mineralys’ drug, especially when it comes to coverage by insurers. Full data on AstraZeneca’s baxdrostat will come in a late‑breaking session at the European Society of Cardiology’s annual meeting in Madrid, Spain, in August.