# Preclinical Development of M10 as a Therapeutic Agent for Scleroderma

> **NIH NIH R41** · FIBROBIOLOGICS, LLC · 2021 · $252,010

## Abstract

Abstract
Scleroderma (systemic sclerosis, SSc) is an autoimmune fibrotic disorder that affects multiple
systems including the skin and visceral organs of the body. The leading cause of death in
scleroderma patients is pulmonary dysfunction resulting from progressive interstitial lung
fibrosis. Although immunosuppressive agents and other drugs such as nintedanib may stabilize
lung function, long-term treatment is required, significant toxicity may occur, and many patients
fail to respond to such therapies. Around 40% of scleroderma-associated interstitial lung
disease (SSc-ILD) patients will die within 10 years of diagnosis; therefore, there is an urgent
need for new therapeutic approaches that would be more effective and less toxic than current
treatments.
Small peptides are widely involved in multiple cellular events and play very important roles in
various cell functions. Interest in peptides as potential drug candidates remains high. With
advances in such fields as chemical synthesis and peptide formulation, peptide drugs -
especially short synthetic and long-acting peptides - are quickly increasing in the global market.
The advantages of small peptides as drugs include their high biological activity, high specificity,
and low toxicity.
FibroBiologics, LLC proposes to develop the novel peptide M10 as an efficacious antifibrotic
therapeutic agent, with a lead indication for the treatment of patients who suffer from SSc-ILD.
In Specific Aim 1, we will determine basic PK parameters, metabolism, biodistribution, and
toxicity of M10 after subcutaneous administration in mice. In Specific Aim 2, we will define the
efficacious dosing of M10 in two different animal models of SSc-ILD: bleomycin-induced
therapeutic mouse model and FSP-driven TβR1CA mouse model. The successful completion of
these two specific aims will provide important information about the feasibility of developing M10
as a novel antifibrotic therapeutic and will justify further studies focusing on gaining FDA
clearance, scaling production, and a human clinical trial.

## Key facts

- **NIH application ID:** 10382679
- **Project number:** 1R41AR079303-01A1
- **Recipient organization:** FIBROBIOLOGICS, LLC
- **Principal Investigator:** GALINA S BOGATKEVICH
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $252,010
- **Award type:** 1
- **Project period:** 2021-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10382679

## Citation

> US National Institutes of Health, RePORTER application 10382679, Preclinical Development of M10 as a Therapeutic Agent for Scleroderma (1R41AR079303-01A1). Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/grant/nih/10382679. Licensed CC0.

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