E-Star BioTech has commenced dosing in its Phase 2 clinical trial of Modified Atrial Natriuretic Peptide (MANP) for treating resistant hypertension, marking a significant advancement in cardiovascular therapeutics. The BOLD-HTN study, designed as a randomized, placebo-controlled, double-blind, multi-center trial, aims to evaluate both the safety and efficacy of MANP in patients with resistant hypertension.
Novel Peptide Development Background
MANP represents a breakthrough in peptide therapeutics, originally discovered by John C. Burnett Jr., MD, Director of the Cardiorenal Research Laboratory at Mayo Clinic. The development program has received substantial backing, with $36 million in combined grant funding and seed-stage private investment supporting its progression through early clinical phases.
The therapy has demonstrated encouraging results in its initial clinical investigations. Multiple Phase 1 studies have established a robust safety profile across various patient populations, including those with hypertension, resistant hypertension, and hypertension with comorbid cardiometabolic syndrome.
Addressing a Global Health Crisis
The trial's initiation comes at a crucial time in global cardiovascular health. Current statistics reveal that hypertension affects approximately 1.28 billion adults aged 30-79 years worldwide. Despite the availability of numerous antihypertensive medications, only 21% of patients achieve adequate blood pressure control, highlighting a significant therapeutic gap that MANP aims to address.
Jesse Crowne, Chief Executive Officer of E-Star Biotech, expressed optimism about the trial's potential: "We are thrilled to have now dosed the first patient in our phase 2 study of MANP, the BOLD-HTN Study. This is the first step towards fully enrolling the study later this year, and finding new treatment pathways for patients with resistant hypertension."
Strategic Partnership and Development Path
The development of MANP stems from a strategic collaboration established in 2021 when E-Star secured a worldwide exclusive license agreement with Mayo Clinic for MANP's development in cardiovascular and metabolic indications. This partnership combines Mayo Clinic's research expertise with E-Star's drug development capabilities.
The company's mission extends beyond this single trial, with a broader goal of addressing the needs of the 79% of hypertension patients who currently struggle to achieve adequate blood pressure control. Through their innovative platform of Natriuretic Peptides, E-Star aims to reduce the burden of premature death associated with uncontrolled hypertension in both developed and developing nations.
