# Development of Novel Immunoregulatory Therapeutics for Asthma

> **NIH NIH R43** · BIOTHERAPEUTICS, INC. · 2024 · $355,935

## Abstract

Development of Novel Immunoregulatory Therapeutics for Asthma
Biotherapeutics Inc (BTI) is an emerging biotech company that synergistically combines the power of advanced
computational modeling with translational experimentation to accelerate the development of novel products for
precision immunology. We have filed patent applications related to novel methods of suppressing inflammation
during autoimmune disease, asthma, and allergy. The goal of this project is to develop and innovative treatment
for asthma that targets a new immunoregulatory pathway in immune and epithelial cells.
Asthma is a chronic, widespread allergic disease with total expenses exceeding $80 billion annually in the U.S.
Current therapies for asthma are modestly successful but leave significant subpopulations of patients without
adequate response. Specifically, type 2 asthma patients can develop steroid dependency, while non-type 2
asthma has a lower responsiveness to current treatments. Recent attempts to target this population have been
unsuccessful, with anti-TNF, anti-IL-17 receptor and chemokine inhibitors failing in clinical trials [2, 3], while
macrolides and methotrexate have shown mild improvement but at high side effect risk [4, 5]. Thus, there is an
unmet medical need for safer and more efficacious asthma therapeutics. In the last years, regulatory T cells
(Treg) have gained increased recognition in the treatment of inflammatory and allergic diseases. Manipulation
of Treg cells to restore their suppressive capacity has been postulated as a promising novel therapeutic
approach. This SBIR Phase I application will develop a novel, oral, once-daily, immunoregulatory
therapeutic for the treatment of asthma.
The Specific Aims are to:
AIM 1. Characterize the therapeutic efficacy and route of administration of the novel immunoregulatory
compound in mouse models of asthma. We will use the ovalbumin and house dust mite models to determine
the therapeutic efficacy by airway resistance, lung histopathology, flow cytometry and cytokine expression.
AIM 2. Determine the translational ability of the novel therapeutic in human primary cells from asthma
patients, by assessing cytokine and metabolic profile, plus suppressive Treg capacity in coculture studies in
bronchial epithelial (HDBE) cells and PBMCs from asthma donors, respectively.
Expected successful outcomes are: i) ≥ 50% suppression of airway resistance and ≥ 50% decreased infiltration
of neutrophils in the lungs of treated mice; and ii) ≥ 70% reduction in IL-8 and IL-6 expression in treated HDBE.
Commercial Application: The impact of this new, oral, immunoregulatory asthma drug has the potential to
disrupt an annual market estimated to reach $20 billion by 2026.

## Key facts

- **NIH application ID:** 10822467
- **Project number:** 1R43HL172516-01
- **Recipient organization:** BIOTHERAPEUTICS, INC.
- **Principal Investigator:** Josep Bassaganya-Riera
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $355,935
- **Award type:** 1
- **Project period:** 2024-09-20 → 2026-03-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10822467

## Citation

> US National Institutes of Health, RePORTER application 10822467, Development of Novel Immunoregulatory Therapeutics for Asthma (1R43HL172516-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10822467. Licensed CC0.

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