The nature of small molecule drugs and human metabolic variability is that effect sizes are usually modest and responses usually vary widely across the population. Some patients see little benefit, some patients have side-effects that limit use, and there is always the opportunity to find an alternative path to a new drug that can be used by those people. Separately, investors don't like risk, and tend to favor investment into development focused on proven markets and proven mechanisms of action. Thus wherever there is a sizable market for small molecule drugs for a specific outcome, such as control of blood pressure, there will be continued development to produce ever more small molecule drugs aimed at that outcome. Whether this is good or bad is a matter of perspective, but a large fraction of investment and activity in the pharmaceutical industry is focused on producing "me too" drugs and incremental improvements.
The data from the Launch-HTN trial show that lorundrostat, an aldosterone synthase inhibitor, is a safe and effective treatment for people with uncontrolled or resistant hypertension, demonstrating consistent blood pressure reductions across a large and diverse patient population. It is the largest phase three trial of an aldosterone synthase inhibitor for the treatment of hypertension. The results are a major milestone toward delivering the first targeted aldosterone synthase inhibitor treatment for uncontrolled or resistant hypertension, which could benefit millions of people affected by the conditions.
"Despite available treatments, more than 40% of adults with hypertension worldwide are not reaching their blood pressure goal. There's a major need to explore novel therapies for hypertension and the Launch-HTN trial addressed this need. The aldosterone pathway plays important role in blood pressure regulation, and leads to blood pressure related complications such as heart failure and kidney problems." 30% of people with hypertension have dysregulated aldosterone, meaning that the body's natural mechanism for controlling aldosterone is disrupted. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production.
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. Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19 mmHg reduction at Week 12 (-11.7mm placebo adjusted).
Link: https://www.eurekale...eleases/1085086
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