An experimental drug from Mineralys Therapeutics succeeded in a pair of trials in people with stubbornly high blood pressure, the biotechnology company said Monday.
Mineralys has been developing the drug, dubbed lorundrostat, in people whose high blood pressure can’t be adequately treated with existing medications. The company says more than half of people with hypertension have this “uncontrolled” and “resistant” form, which in many cases is linked to high levels of a blood pressure-regulating hormone released by the kidneys.
Lorundrostat is designed to help those people by lowering levels of that hormone, known as aldosterone. Phase 2 testing showed placebo-adjusted reductions in blood pressure over the course of a day, results that helped the company raise $192 million in an initial public offering two years ago. The study results disclosed Monday came from more rigorous clinical tests.
In one Phase 3 trial, Mineralys enrolled 1,083 people who have uncontrolled and resistant hypertension despite treatment with two to five other medications. Those patients were randomized to receive either a placebo or a low dose of lorundrostat. Per the study’s protocol, drug recipients could switch from a low dose to a higher one if their blood pressure remained high.
According to Mineralys, a low dose of lorundrostat was associated with a roughly 9-point reduction, when adjusted for a placebo, in a measurement of blood pressure after six weeks of treatment. The difference on that measure, millimeters of mercury or mmHg, grew to about 12 points after 12 weeks. Both results were statistically significant.
The benefits weren’t as strong in those who switched to a higher dose, suggesting the lower one is the “optimum and maximum efficacious dose level,” said Chief Medical Officer David Rodman on a conference call.
The second study, a “pivotal” Phase 2 trial, evaluated 12 weeks of lorundrostat treatment against a placebo in 285 people already on optimized background therapy. Its goal was for lorundrostat to lower, over that time, a measure of blood pressure taken in regular intervals over the course of a day. Lorundrostat was associated with a roughly 8-point placebo-adjusted difference on that measure, according to Mineralys.
A total of 14 people treated in the larger trial, two of which were on the low dose, had treatment-emergent serious adverse events, versus eight placebo recipients. Only one such event was deemed related to treatment.
Rates of high potassium, or hyperkalemia — a side effect investors had been watching for, given the way Mineralys’ drug works — were 1.1% and 1.5%, respectively, in the two treatment groups. In the smaller trial, those rates were 5.3% and 7.4% for drug recipients, Mineralys said.
Mineralys is trying to prove lorundrostat is superior to a similar, competing medicine AstraZeneca acquired in a buyout. Wall Street analysts, then, have been paying close attention to the results to see how Mineralys’ drug compares.
The results appear to have exceeded expectations. In a note to investors last month, Stifel analyst Annabel Samimy said an 8- to 10-point placebo-adjusted difference in mmHg in the Phase 3 trial would be “further validating,” while surpassing that mark would point to “game-changing” efficacy.
“We see guideline and practice-altering potential in these results,” Samimy added in a Monday note.
Evercore ISI analysts Michael DiFiore and Umer Raffat wrote in their own client note that the results make Mineralys’ drug a “derisked, almost-commercial stage cardiometabolic asset.”
“We expect the stock to be very strong” on the results, they added. Shares climbed about 44%, to just over $15 apiece, in early trading.
Mineralys will report detailed results at a medical meeting later this month. It hasn’t specified when it might seek regulatory approval, though on the conference call, CEO Jon Congleton said the company wants to compile more safety data first.