# Translating a Novel Therapeutic Approach to the Treatment for Idiopathic Pulmonary Fibrosis

> **NIH NIH R44** · VASARYA THERAPEUTICS, INC. · 2024 · $356,250

## Abstract

Project Abstract
The goal of this Fast-Track SBIR application is to develop a novel drug candidate to treat
Idiopathic pulmonary fibrosis (IPF). IPF is a fatal disease that remains uncurable and carries a
median survival of 2-3 years post diagnosis. The two current FDA-approved drugs Nintedanib
and Pirfenidone marginally extend quality-adjusted life years while presenting severe life-altering
side effects, resulting in extremely poor compliance. Current pipeline therapeutics are focused
on more effective targets to improve functional outcomes but many, if not all, present significant
safety concerns by targeting critical, systemically active receptors and intracellular signaling
proteins. Our tool compound, VSR-H5, has demonstrated an ability to 1) specifically target only
regions of ongoing fibrosis within diagnosed IPF patient lung tissues while not binding healthy
tissues/regions; 2) selectively inhibit activation of patient-derived fibroblasts’ on pro-fibrotic
mimetic extracellular matrix (ECM) in vitro; and 3) mitigate fibrosis progression in multiple in vivo
mouse models of lung fibrosis and a clean tox profile. Our approach specifically avoids systemic
disruption of critical, normal receptor engagement by targeting a unique, cryptic epitope that is
only exposed in tissues undergoing active fibrosis. In this proposal we will first (Phase I) perform
affinity maturation and liability assessment and removal to create a pool of candidate antibody
drugs. Then in Phase II we will perform successive selection assays to establish our primary
drug candidate from the pool generated in Phase I and then further establish its translatability
through a series of PK/PD, toxicity/safety, and efficacy analyses in established animal models,
while exploring potential formulations for future process development and manufacturing. At the
successful conclusion of this project, we will be poised to design and initiate IND-enabling studies.

## Key facts

- **NIH application ID:** 10915918
- **Project number:** 1R44HL170936-01A1
- **Recipient organization:** VASARYA THERAPEUTICS, INC.
- **Principal Investigator:** Ping Hu
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $356,250
- **Award type:** 1
- **Project period:** 2024-09-15 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10915918

## Citation

> US National Institutes of Health, RePORTER application 10915918, Translating a Novel Therapeutic Approach to the Treatment for Idiopathic Pulmonary Fibrosis (1R44HL170936-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10915918. Licensed CC0.

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