Mineralys Therapeutics’ aldosterone synthase inhibitor has chalked up a third clinical win in recent months, demonstrating once again its potential to reduce blood pressure in patients with hypertension.
The biotech was evaluating a 25-mg dose of the drug, dubbed lorundrostat, in the phase 2 Explore-CKD study of 59 patients with hypertension and chronic kidney disease (CKD). Patients receiving lorundrostat saw their mean systolic blood pressure fall by 9.25 mmHg after four weeks—compared with a 1.76-mmHg drop for the placebo group—allowing the study to hit its primary endpoint.
When it came to urine albumin-to-creatinine ratio, a measure of kidney damage, Mineralys also saw a “clinically meaningful reduction” of 30.5% for the lorundrostat group compared with a 6.6% drop for the placebo group, the biotech said in a June 17 press release.
Two patients who received lorundrostat reported a serious adverse event, versus none of the placebo group, according to Mineralys. The company described the drug as having a “favorable safety and tolerability profile.”
One patient in the lorundrostat group discontinued treatment due to the elevation of potassium associated with reduced estimated glomerular filtration rate (eGFR)—a measure of kidney function—and another stopped because of a reduction in eGFR alone.
The latest clinical win follows a dual set of phase 3 and phase 2 results back in March. In that data drop, Mineralys reported that lorundrostat reduced systolic blood pressure in a late-stage study of more than 1,000 adults with uncontrolled hypertension or resistant hypertension.
This morning's result keeps Mineralys on track for its previously announced timeline of holding a pre-NDA meeting with the FDA in the fourth quarter of the year ahead of submitting an approval application for lorundrostat. The win also marked “the fourth trial showing clinically meaningful effects of lorundrostat for the treatment of hypertension,” Mineralys CEO Jon Congleton pointed out.
“In a renally compromised hypertensive population, this trial demonstrated the benefit of lorundrostat in safely reducing both systolic blood pressure and proteinuria—a surrogate of kidney protection,” Congleton added.
“Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population,” the CEO said. “Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.”
The new results are a further clinical validation of the theory that inhibiting the aldosterone synthase enzyme can lower levels of a blood pressure hormone. Mineralys isn’t the only company to have followed this path, with AstraZeneca having entered the space through its $1.8 billion takeover of CinCor Pharma in 2023.