Immuno-modulation based

Treatment of Heart Failure with Preserved Ejection Fraction

Leveraging recent findings in cardio-immunology and Phase II clinical trials, we have developed a first-in-class immunomodulatory molecule to treat heart failure with preserved ejection fraction.

Heart Failure Death Rate per 100,000 (any mention), All Ages, All Races/Ethnicities, Both Genders, 2014-2016. View interactive map

The Unmet Need

We are losing the fight against heart failure

• 6,000,000 Americans have heart failure

• This costs our nation >$30bn/year

• >50% of patients have a form of heart failure, heart failure with preserved ejection fraction (HFpEF), for which we have few treatment options

• Heart failure is a leading cause of hospitalizations and death every year

Currently there is only 1 FDA approved therapy to treat HFpEF

We need new tools to treat heart failure with preserved ejection fraction

A Game Changer

The Phase II PIROUETTE trial has recently shown that pirfenidone can treat HFpEF

Nature Medicine, volume 27, pages1477–1482 (2021)

The Problem

Pirfenidone is limited by lack of intellectual property and poor pharmacokinetics resulting in the need for three times a day dosing, CNS penetration, and frequent side effects

The Solution

Optimize pirfenidone through conjugation

We eliminate the known shortcomings of pirfenidone by adding a small PEG chain (<500 kD)

  • Tried and true method to extend half-life, and reduce CNS penetration of suitable small molecules

  • Does not reduce bioavailability after oral administration

  • Same technology used for Movantik®

The Breakthrough

We have identified a PEGylated pirfenidone superior to pirfenidone

Better tolerated

in vivo

More cardioprotective

in vivo

Composition of matter IP and multiple potential applications

Intellectual property

  • Patentability and FTO assessment performed by Global Patent Group, LLC

  • FTO cleared and path identified for broad composition of matter IP protection

  • Patent application filed by WashU in July 2018, key claims upheld by international searching authority

Potential applications

  • Treatment of HFpEF (see PIROUETTE trial)

  • Prevention of post MI heart failure

  • Treatment of Muscular dystrophy associated cardiomyopathy (Orphan indication, see Pirfenidone in mdx mice)

  • Prevention of Post-op Afib (see Pirfenidone studies in dogs)

  • Prevention/treatment of Immunotherapy associated myocarditis e.g., COVID-related)

  • Treatment of Idiopathic pulmonary fibrosis (current application of Pirfenidone)

  • Etc.

Fit for the Task

Meet The Team

Douglas Mann, MD

Founder, Chief Scientific Advisor

Lewin Distinguished Professor of Cardiovascular Disease;Professor of Medicine, Cell Biology, and Physiology, Washington University School of Medicine

Luigi Adamo, MD, PhD

Founder, CEO

Heart Failure Specialist and Director for Cardiac Immunology at Johns Hopkins University.

Jennifer Riggs, PhD

Head of Medicinal Chemistry

21 years experience; lead chemist for 2 successful PEG small molecules at Nektar Therapeutics

Bradley Keller, PhD

VP Preclinical Development

Drug development expert;30+ years in pharma;7+ years in small/startup biopharma companies

Jennifer Baltz, PhD

Chief Operating Officer

Harvard-trained biochemist;Serial entrepreneur;Phase I and II SBIR PI