# Development of a novel lipase inhibitor for the treatment of acute pancreatitis

> **NIH NIH R44** · LAMASSU PHARMA INC. · 2020 · $1,498,822

## Abstract

Project summary/abstract
This proposal seeks the development of a novel therapeutic for acute pancreatitis, which is a major unmet
medical need with no effective treatment. Our approach builds upon a body of clinical and preclinical data that
strongly implicate lipolysis and lipotoxicity as major driving factors in converting mild acute pancreatitis to
severe acute pancreatitis, which is defined by sustained organ failure. In addition, this work is supported by
data demonstrating that inhibition of lipase activity abrogates the organ failure and indicators of systemic
inflammatory response syndrome (SIRS) found in clinically relevant models of severe acute pancreatitis. Our
status as a company is that we have a lead compound that has been validated in preliminary safety studies,
and multiple preclinical efficacy models with outstanding efficacy. We further have in place an expert team in
the fields of preclinical and clinical translational research, pancreatitis research and treatment,
entrepreneurship, business development, pharmaceutical partnering, and clinical trials. Our primary goal is to
rapidly, efficiently, and diligently advance this therapy through the translational pathway. In light of our strong
feasibility data, we are submitting this as a Direct-to-Phase 2 proposal, which will allow us to most rapidly and
efficiently move this compound forward into clinical trials (planned at the conclusion of this award). The current
gap in moving this treatment into clinical trials is to complete the safety studies needed to submit an
investigational new drug (IND) application. As such, the next phase of development is to complete the IND-
enabling safety studies. The objectives of this proposal are the completion of the following specific aims:
Aim 1: Complete dose range finding, ADME, in vitro safety and 7-day toxicity and toxicokinetics (TK)
studies. Year 1 milestones: 1) completion of dose range finding, ADME, genetic toxicology, 7-day toxicity and
toxicokinetic studies, 2) completion of pre-IND submission and pre-IND meeting.
Aim 2: Complete in vivo toxicology and safety pharmacology studies. Year 2 milestones: 1) completion of
GLP toxicology and safety pharmacology studies, 2) IND submission.
At the completion of this proposal, we will have an IND-ready asset, with a committed, experienced, and
successful clinical development team ready to take it through clinical trials.

## Key facts

- **NIH application ID:** 10009653
- **Project number:** 1R44DK125219-01
- **Recipient organization:** LAMASSU PHARMA INC.
- **Principal Investigator:** Gabi Hanna
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,498,822
- **Award type:** 1
- **Project period:** 2020-07-07 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10009653

## Citation

> US National Institutes of Health, RePORTER application 10009653, Development of a novel lipase inhibitor for the treatment of acute pancreatitis (1R44DK125219-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10009653. Licensed CC0.

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