Mineralys Therapeutics Reports Positive Results in Hypertension Trials, Stock Surges

Mineralys Therapeutics has announced significant clinical successes for its hypertension drug lorundrostat, leading to a substantial increase in the company's stock price. The aldosterone synthase inhibitor demonstrated efficacy in two separate clinical trials, potentially positioning it as a transformative therapy for millions of patients with uncontrolled hypertension.

Double Clinical Wins for Lorundrostat

Mineralys revealed that lorundrostat met primary endpoints in both the phase 3 Launch-HTN trial and the phase 2 Advance-HTN trial. The Launch-HTN study, involving 1,083 adults with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), showed a statistically significant reduction in systolic blood pressure at week six compared to placebo.

Patients receiving 50 mg of lorundrostat experienced a 16.9 mmHg decrease in blood pressure, translating to a placebo-adjusted reduction of 9.1 mmHg. This benefit persisted through week 12, with a placebo-adjusted reduction of 11.7 mmHg. Notably, the drug's efficacy was consistent across both uHTN and rHTN patient groups.

In the Advance-HTN trial, lorundrostat was evaluated as an add-on therapy to optimized background treatment. The 50 mg dose achieved a placebo-adjusted blood pressure reduction of 7.9 mmHg at week 12.

Safety Profile and Market Implications

Mineralys reported a favorable benefit-risk profile for lorundrostat based on the trial results. In the Launch-HTN study, only one patient in the 50 mg cohort experienced a treatment-related serious adverse event. The incidence of hyperkalemia (serum potassium above 6.0 mmol/L) was relatively low, with rates of 1.1% and 1.5% in the 50 mg and dose escalation arms of Launch-HTN, respectively.

CEO Jon Congleton emphasized the drug's potential, stating, "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."

The market responded enthusiastically to the news, with Mineralys' stock price surging by 45% in pre-market trading on Monday, reaching $15.20 from Friday's closing price of $10.52. This positive reception follows the company's recent $192 million IPO, which debuted at $16 per share.

Competitive Landscape and Future Outlook

Mineralys' success with lorundrostat reinforces the potential of aldosterone synthase inhibition as a promising approach to hypertension treatment. The company is not alone in pursuing this strategy, as evidenced by AstraZeneca's $1.8 billion acquisition of CinCor Pharma in 2023, a move that signaled the pharmaceutical giant's entry into this therapeutic space.

With three successful clinical trials now completed, Mineralys is positioned to potentially seek regulatory approval for lorundrostat. The company believes that the clinical profile demonstrated by the drug supports its significant commercial value and could lead to its establishment as a novel agent in the treatment of hypertension.