A new era for hypertension management

First in Human Study
The First in Human Study of MANP was done in two parts. The first part was designed as an open label sequential single ascending dose study in 3 cohorts of essential hypertensive subjects withdrawn from antihypertensive medications for 2 weeks. The second part was a randomized, double blind, placebo-controlled multiple ascending dose (MAD) design in 3-4 cohorts of hypertensive subjects on at least 3 medications at screening. In both parts, MANP was found to have a favorable safety profile and BP lowering properties.
Reference: Chen H H et al Hypertension. 2021

Difficult to Control Hypertension Study (Phase1B)
This was a double-blind, placebo controlled randomized trial in Difficult to Control Hypertension patients comprised of approximately 50% non-African Americans (NAA) and 50% AA. MANP was administered in 6 cohorts receiving ascending subcutaneous (SQ) doses of MANP once daily from 3 ug/kg to a maximal dose of 7 ug/kg or placebo for 5 days. Once a day SQ administration of MANP in RH subjects activates cGMP and reduces SBP and preserves GFR. At higher doses of MANP, SBP reductions were greater in AA compared to NAA. MANP also demonstrated Aldo inhibiting actions compared to placebo. Importantly, MANP was overall safe and well-tolerated.
Reference: NCT05247528, ESC abstract – to be shared in September 2024

HTN-Metabolic Syndrome Study
This was an AHA- sponsored study, conducted as a double-blind, placebo-controlled trial in 22 patients and demonstrated that a single subcutaneous injection of M-atrial natriuretic peptide was safe, well-tolerated, and exerted pleiotropic properties including blood pressure–lowering, lipolytic, and insulin resistance–improving effects.
Reference: NCT03781739, Ma et al Am Coll Cardiol Basic Trans Science 2024

Heart Failure with Preserved Ejection Fraction Study
The purpose of this study is to look at the differences in how individuals with heart failure with preserved ejection fraction in the presence of chronic kidney disease (HFpEF-CKD) and exercise induced dyspnea without objective findings of fluid retention (HFpEF-EI) bodies function using drugs Sacubitril/Valsartan (Entresto) and MANP.
Reference: NCT05279742

Difficult to Control Hypertension Study (BOLD-HTN)
BOLD-HTN, is a currently ongoing multicenter, double-blind, placebo-controlled trial, will randomize 120 patients with difficult to control/resistant hypertension on 3 or more antihypertensive medications to MANP or standard therapy. At least 25% of subjects will be African Americans and up to 10% will have eGFR between 20-29 mL/min/1.73m². Subjects will receive MANP or placebo with weekly titration, based on their systolic BP (SBP).
Reference: NCT06343298