Mineralys Therapeutics reports Phase 2 CKD trial meets blood‑pressure endpoint
Mineralys Therapeutics announced that its Phase 2 Explore‑CKD trial of lorundrostat 25 mg once daily met the primary endpoint, showing a placebo‑adjusted systolic blood‑pressure reduction of 7.5 mmHg at four weeks. The study involved 59 participants with uncontrolled hypertension and chronic kidney disease, and also demonstrated reductions in urinary albumin‑to‑creatinine ratio and serum aldosterone. The company has filed a new drug application with the FDA and plans further trials.
Why it matters
The company says the data support advancing lorundrostat toward regulatory approval, which could add a novel hypertension therapy to its pipeline and affect MLYS valuation (the company’s press release).
Key facts
- 1The Explore‑CKD trial enrolled 59 participants with uncontrolled hypertension, stage 1‑3b CKD and albuminuria. stocktitan.net
- 2At week four, lorundrostat 25 mg achieved a 9.3 mmHg reduction in automated office systolic blood pressure versus 1.8 mmHg for placebo, a placebo‑adjusted reduction of 7.5 mmHg (95 % CI ‑12.3 to ‑2.7; p = 0.0024). investing.com
- 3Participants had a mean age of 64.6 years; 76 % had type 2 diabetes; baseline mean automated office systolic blood pressure was 149 mmHg. investing.com
- 4Lorundrostat reduced urinary albumin‑to‑creatinine ratio by 30.5 % from baseline and by 25.6 % versus placebo (p = 0.0015). investing.com
- 5Serum aldosterone decreased by 41.5 % with lorundrostat, while it increased by 1.8 % with placebo. investing.com
- 6The trial was conducted at 42 sites across the United States. investing.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.