NIH Awards $1.7M Grant for Celdara Medical and Pulmatrix to Develop an Inhaled Biologic Treatment for Idiopathic Pulmonary Fibrosis

Celdara Medical, LLC and Pulmatrix, Inc. PULM today announced that the National Heart Lung and Blood Institute of the National Institutes of Health has awarded a three-year, $1.7 million Fast Track Small Business Innovation Research grant to fund the companies' development of an inhaled biologic to treat idiopathic pulmonary fibrosis. The biologic, CM-YJH01, targets a novel pathway intended to prevent epithelial cell death. Celdara Medical will combine CM-YJH01 with Pulmatrix's novel iSPERSE™ dry powder technology, which facilitates efficient administration of macromolecules to the lungs. The goal is to design an inhaled treatment candidate that addresses progressive scar tissue build up (fibrosis) directly at the affected disease site of patients' lungs. Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, remarked, "We are thankful to NHLBI and this will accelerate our collaboration with Prof. Janssen-Heininger and Pulmatrix. This is an important opportunity to advance the development of this novel therapy, which has demonstrated its ability to not just halt, but also reverse fibrosis in preclinical models. Successful execution will get us to the clinic and bring us closer to helping patients." The grant was awarded in part based on results of preclinical testing at the University of Vermont, which demonstrated that therapeutic administration of CM-YJH01 reduced lung fibrosis and improved multiple lung parameters in difficult-to-treat preclinical models of disease. Dr. Yvonne Janssen-Heininger, Professor of Pathology at the University of Vermont and Scientific Founder at Celdara Medical conducted the original research underlying this therapy, and remains fully engaged in the preclinical development efforts. Dr. Janssen-Heininger noted, "The rapid build-up of scar tissue in IPF patients has historically been difficult to halt or reverse. Our initial results have been compelling, and we're eager to take these next steps toward the clinic." Pulmatrix's iSPERSE™ (Inhaled Small Particles Easily Respirable and Emitted) particles are engineered to be small, dense, and easily dispersible upon inhalation, thereby delivering drugs more efficiently to the airways. The Company has demonstrated preclinically that iSPERSE™ can deliver antibodies to the lungs, a finding that highlights the technology's potential to efficiently deliver inhaled biologics and other macromolecules. Dr. David Hava, CSO of Pulmatrix, commented, "We believe that an inhaled version of CM-YJH01 is an attractive therapeutic approach, as we can deliver the medication directly to the site of disease. Several first generation drugs have made important contributions to the treatment of IPF and we believe there remains an opportunity to further improve efficacy while at the same time reducing the side effects that can result from systemic delivery. Idiopathic Pulmonary Fibrosis (IPF) is a chronic, progressive, and devastating disease characterized by damage and accumulation of scar tissue in the lungs, resulting in significantly impaired lung function, which eventually results in death. Disease prognosis is very poor – most affected individuals survive only 3-5 years after diagnosis. In the US, there are approximately 100,000 patients living with IPF. Each year approximately 40,000 new cases are diagnosed while approximately the same number of patients succumb to the disease. Typically, diagnosis occurs between 40 and 70 years of age, and an aging population is expected to lead to higher prevalence of the disease. Research reported in this press release was supported by the National Heart, Lung and Blood Institute of the National Institutes of Health under award number R44 HL129593-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.