Hyperkalemia

ECG diagnostics software platform AccurKardia and cardiac medical technology company HeartBeam are joining forces to make AccurKardia's ECG analysis software available on HeartBeam's devices. HeartBeam's cable-free, 12-lead ECG system captures electrical signals from the heart from three directions to assess arrhythmias. The platform is designed for portable devices so physicians can identify cardiac health trends and acute conditions wherever patients are. In January, HeartBeam submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software that assesses rhythms and arrhythmias, sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia and sinus with premature ventricular contraction and premature atrial contraction. AccurECG aims to simplify the interpretation of ECGs by identifying visible and hidden signals and transforming them into diagnostic and broad biomarkers. The companies claim that the addition of AccurKardia’s device-agnostic automated ECG interpretation platform to HeartBeam’s device has the potential to deliver earlier and more accurate management of heart health. "This collaboration is a major step forward in delivering a more accessible and scalable solution for remote cardiac monitoring," Robert Eno, CEO of HeartBeam, said in a statement. "AccurKardia shares our mission of improving cardiac outcomes through technological innovation and together we can accelerate the delivery of unprecedented cardiac insights to individuals and physicians outside of a medical facility." THE LARGER TREND In February, HeartBeam announced a public offering of 5.8 million shares of its common stock at $1.70 per share. The company expected gross proceeds of $10 million from the offering. In a statement, the company said it was using the net proceeds for commercial-readiness activities, research and development, clinical and regulatory projects, and working capital. In January, AccurKardia received FDA Breakthrough Device Designation for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. The investigational technology uses Lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia (excess potassium in the blood) that could lead to sudden cardiac arrest. In 2024, AccurKardia's Aortic Valve Stenosis (AVS) ECG-based AI screening software was granted FDA Breakthrough Device Designation.

“We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value,” Mineralys\' CEO said.\n 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.

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 cant 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 studys 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 werent 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 hasnt 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. '