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Chronic intrapulmonary delivery of a novel small molecule Wnt/beta-catenin inhibitor for Idiopathic Pulmonary Fibrosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL142357-01
Agency Tracking Number: R41HL142357
Amount: $299,974.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-303
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-05-15
Award End Date (Contract End Date): 2019-05-14
Small Business Information
1740 S MORGANTOWN RD
Greenwood, IN 46143-8348
United States
DUNS: 968385273
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 AI LAM
 (312) 503-3106
 a-lam4@md.northwestern.edu
Business Contact
 JONATHAN NORTHRUP
Phone: (317) 517-9500
Email: jon@betacatpharma.com
Research Institution
 NORTHWESTERN UNIVERSITY AT CHICAGO
 
750 N LAKE SHORE DR
CHICAGO, IL 60611-3152
United States

 Nonprofit College or University
Abstract

Project Summary
Idiopathic pulmonary fibrosisIPFis a devastatingprogressive disease with no known cure
and no treatment that convincingly alters the disease course or significantly improves mortalityThe objective of this proposal is the development of nebulized delivery of the small molecule
inhibitor of Wntcatenin signalingBCfor Idiopathic Pulmonary FibrosisPre clinical
studies in rodentsdogsand minipigs show that BChas favorable pharmacokinetics and
safety data with intravenous administrationwhich provides support for short term useHoweverin a chronic diseasesuch as IPFwhich requires prolonged treatmentintravenous
administration is undesirable for patientsNebulization of BCwould achieve high local
levels of the drugwhile minimizing off target side effects in other critical organswhich is key for
the chronic treatment of patients with pulmonary fibrosisIn Specific Aima respiratory
formulation of BCwill be optimized to generate particle sizesm to allow for maximal
distribution into the alveolar spacesIn Specific Aimthe efficacy and pharmacodynamics of
nebulized administration of BCwill be determined in vivo using two mouse models of
chronic pulmonary fibrosisusing intratracheally administered asbestos and repetitive
intratracheal administration of bleomycinboth of which create non resolving fibrosisNebulized
BCwill be administered after the establishment of pulmonary fibrosisin order to
determine whether the drug improves the resolution of fibrosiswhich would increase its
translational potential and make a clinically meaningful impact for patientsThe overall goal for
this Phaseapplication is the generation of high quality pre clinical data that will provide a
highly compelling rationale for clinical trials for the treatment of IPF and potentially other fibrotic
lung diseases Project Narrative
The goal of this proposal is the development of nebulized delivery of the small molecule inhibitor
of Wntcatenin signalingBCfor Idiopathic Pulmonary FibrosisThis approach would
achieve high local levels of the drugwhile minimizing off target side effects in other critical
organsfor the chronic treatment of patients with pulmonary fibrosisThe findings from these
studies will provide a highly compelling rationale for clinical trials using nebulized BCfor
the treatment of IPF and potentially other fibrotic lung diseases

* Information listed above is at the time of submission. *

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