# IL-10NanoCap® for Therapy of Familial Adenomatous Polyposis

> **NIH NIH R44** · THERAPYX, INC. · 2024 · $960,296

## Abstract

Abstract
This SBIR Phase IIb proposal builds on the success of our Fast-track award supporting the pre-clinical
development of FAPXIL, an oral sustained-release micro-particulate formulation of Interleukin-10 for the
treatment of Familial Adenomatous Polyposis (FAP). The Phase I portion of our Fast-track project provided
validation of our large-batch methods and activity in a clinically-relevant murine model of human FAP. The
Phase II segment further optimized the treatment protocol, defined the long-term therapeutic potential and
assessed potential effects of long-term treatment on local and systemic immune homeostasis. Additional Phase
II tasks included production of multiple scale-up batches for validation of batch-to-batch consistency, long-term
stability analysis, transfer of manufacturing methods to a CMO with GMP capability, and a Type C pre-IND
meeting with the FDA to inform future toxicology. Agency recommendations and responses to our interrogatives
form the Aims of this Phase IIb application to continue the development of FAPXIL® towards clinical trials in FAP
patients. To this end, Aim 1 will continue pharmaceutical quality and development activities; Aim 2 will establish
safety, tolerability and pK of FAPXIL in non-human primates; Aim 3 will complete a Type B pre-IND meeting with
the US FDA; Aim 4 will assess Investigational New Drug (IND) readiness and submit an orphan-drug designation
request for FAPXIL. The Aims proposed above will enable Therapyx, Inc. to continue pre-clinical work required
to obtain IND approval for this first-in-class oral biologic. Subsequent production of clinical grade drug product
and IND submission will be supported via NIH's SBIR Commercialization Readiness Program and Company
funds.

## Key facts

- **NIH application ID:** 10851861
- **Project number:** 5R44DK117687-05
- **Recipient organization:** THERAPYX, INC.
- **Principal Investigator:** DOMINICK AUCI
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $960,296
- **Award type:** 5
- **Project period:** 2019-03-07 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10851861

## Citation

> US National Institutes of Health, RePORTER application 10851861, IL-10NanoCap® for Therapy of Familial Adenomatous Polyposis (5R44DK117687-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10851861. Licensed CC0.

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