"Mineralys Therapeutics Unveils Positive Data From Two Trials For Hypertension Drug Candidate"

Mineralys Therapeutics, Inc. (NASDAQ: MLYS) has just announced positive topline results from two pivotal trials evaluating lorundrostat for the treatment of uncontrolled or resistant hypertension. The Launch-HTN Phase 3 trial and the Advance-HTN Phase 2 trial both met their primary endpoints, demonstrating statistically significant and clinically meaningful reductions in systolic blood pressure. This news has sent Mineralys' stock soaring, with shares 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.

The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications. The trial met its endpoints demonstrating clinically meaningful, statistically significant mean reduction from baseline in placebo-adjusted systolic blood pressure at week six and the benefit was sustained with potential further reduction through week 12. 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 Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 pivotal trial that evaluated the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN, when used as add-on therapy to an optimized background treatment of two or three antihypertensive medications in adult subjects. The trial met its primary endpoint, with placebo-adjusted reduction from baseline in systolic blood pressure assessed with 24-hour average blood pressure measurement at week 12 of -7.9 mmHg in subjects treated with 50 mg of lorundrostat.

Both trials demonstrated a favorable safety and tolerability profile for lorundrostat. The incidence of hyperkalemia, a potential side effect, was low and manageable. In the Launch-HTN trial, the rates were 1.1% and 1.5% in the 50 mg arms and the dose escalation arms, respectively. In the Advance-HTN trial, the rates were 5.3% and 7.4%. The low rates of serious adverse events and the manageable side effects support a favorable benefit-risk profile for lorundrostat, which is crucial for regulatory approval.

The statistically significant reductions in systolic blood pressure observed in the trials of lorundrostat have several potential regulatory and commercial implications. These results could significantly influence the approval process and market adoption of the drug. The Launch-HTN trial demonstrated a 9.1 mmHg placebo-adjusted reduction in systolic blood pressure at week 6 and an 11.7 mmHg reduction at week 12. These results are statistically significant (p-value < 0.0001) and clinically meaningful, as they show a sustained benefit over time. The Advance-HTN trial also met its primary endpoint with a 7.9 mmHg placebo-adjusted reduction in 24-hour blood pressure monitoring at week 12. This further supports the efficacy of lorundrostat in managing hypertension.

The favorable safety profile, clinically meaningful reductions in blood pressure, and the addressable market of patients with uncontrolled hypertension position lorundrostat as a strong candidate for regulatory approval and commercial success. The robust data package now includes three successful trials, meaningfully derisking regulatory approval prospects. While specific timeline for filing wasn't disclosed, the comprehensive dataset suggests a straightforward path to submission.



The positive data from the trials transform Mineralys Therapeutics' commercial outlook. Successfully hitting primary endpoints in both studies establishes lorundrostat as a potential first-in-class aldosterone synthase inhibitor for resistant hypertension—a condition with significant unmet need and commercial opportunity. The addressable market of 15-20 million patients in the US alone represents substantial revenue potential. Resistant hypertension patients typically fail multiple generic medications, making this a premium-priced segment where payers recognize the economic burden of uncontrolled cardiovascular disease.

Lorundrostat's clinical profile offers several commercial advantages. Its efficacy as an add-on therapy to existing regimens and its favorable safety profile make it a strong candidate for market adoption. The once-daily oral dosing, placebo-like tolerability, and efficacy demonstrated as add-on to existing regimens make it an attractive option for physicians seeking effective add-on therapies for difficult-to-treat patients.

In summary, the statistically significant reductions in systolic blood pressure observed in the trials of lorundrostat have the potential to significantly influence the approval process and market adoption of the drug. The favorable safety profile, clinically meaningful reductions in blood pressure, and the addressable market of patients with uncontrolled hypertension position lorundrostat as a strong candidate for regulatory approval and commercial success. The robust data package now includes three successful trials, meaningfully derisking regulatory approval prospects. While specific timeline for filing wasn't disclosed, the comprehensive dataset suggests a straightforward path to submission.