MANP for High Blood Pressure
(BOLD-HTN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.
Do I need to stop my current medications for the trial?
The trial does not specify that you need to stop your current medications. In fact, you must be taking at least three different blood pressure medications to participate.
Is MANP safe for humans?
Research on atrial natriuretic peptides, including MANP, shows they can lower blood pressure and have beneficial effects on the heart and kidneys. However, a mutation in the peptide has been linked to atrial fibrillation (irregular heartbeat) in some people, indicating potential safety concerns that need further investigation.12345
How is the drug MANP different from other high blood pressure treatments?
MANP is unique because it activates a specific receptor (pGC-A) that helps lower blood pressure and enhances kidney function, while also reducing the production of aldosterone, a hormone that can raise blood pressure. This makes it different from other treatments that may not target these specific pathways.26789
What data supports the effectiveness of the drug MANP for high blood pressure?
Research shows that MANP, a type of atrial natriuretic peptide, can lower blood pressure and improve kidney function in animal models of high blood pressure. It also reduces the production of aldosterone, a hormone that can increase blood pressure, suggesting it may be effective in treating high blood pressure in humans.256810
Who Is on the Research Team?
David Smith, MD
Principal Investigator
E-Star BioTech, LLC
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with resistant hypertension, taking three or more blood pressure medications including a diuretic and an ACEi/ARB. They must have a certain level of kidney function (eGFR ≥ 30 mL/min/1.73m2), not be able to bear children or agree to use contraception, and have specific high blood pressure readings.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous MANP or placebo once daily for 42 days to evaluate safety and efficacy in reducing systolic blood pressure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and metabolic biomarkers
What Are the Treatments Tested in This Trial?
Interventions
- MANP
Find a Clinic Near You
Who Is Running the Clinical Trial?
E-Star BioTech, LLC
Lead Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Mayo Clinic
Collaborator
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor