Mineralys Therapeutics enjoyed a big stock bump after its aldosterone synthase inhibitor chalked up wins in two types of hypertension.
The therapy, called lorundrostat, hit the primary endpoint of the phase 3 Launch-HTN trial of 1,083 adults with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) by demonstrating a statistically significant mean reduction from baseline in placebo-adjusted systolic blood pressure at week six.
Specifically, patients receiving 50 mg lorundrostat saw a 16.9 mmHg in their blood pressure, which equated to a placebo-adjusted reduction of 9.1 mmHg. This benefit continued into week 12, which demonstrated a placebo-adjusted reduction of 11.7 mmHg, Mineralys said in a March. 10 release.
The change in blood pressure was similar regardless of whether the patients had uHTN, meaning they were using two background antihypertensives, or had rHTN, meaning they were on between three and five hypertensives, the biotech noted.
In the same release, Mineralys revealed that a phase 2 Advance-HTN trial of lorundrostat in uHTN or rHTN when used as add-on therapy to an optimized background treatment of two or three antihypertensive medications also hit its endpoint. Specifically, 50 mg lorundrostat was linked to a placebo-adjusted reduction in blood pressure of 7.9 mmHg at week 12.
Only one patient in the 50 mg cohort of Launch-HTN experienced a treatment-related serious adverse event, and Mineralys said the results from both trials support a favorable benefit-risk profile for lorundrostat.
The incidence of hyperkalemia—defined as serum potassium above 6.0 mmol/L—in the 50 mg arms and the dose escalation arms, was 1.1% and 1.5%, respectively, in Launch-HTN trial and 5.3% and 7.4% in Advance-HTN.
“The positive results and clinically meaningful reduction in blood pressure observed in the Launch-HTN and Advance-HTN trials show us that lorundrostat has the potential to be a transformative new therapy for the approximately 15 to 20 million patients with uncontrolled hypertension in the United States,” Mineralys CEO Jon Congleton said in the release.
“We have now completed three successful clinical trials demonstrating the efficacy, safety and tolerability of lorundrostat and the importance of targeting dysregulated aldosterone,” Congleton added. “We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value.”
Investors appeared equally impressed, sending Mineralys’ stock was up initially 45% to $15.20 in pre-market trading Monday from a Friday closing price of $10.52. The biotech went public via a $192 million IPO and a debut share price of $16.
This morning’s results are a further endorsement 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.