Moerae Matrix Initiates Phase 1 Clinical Trial of MMI-0100, a First-in-Class Inhibitor of MK2, for Treatment of Idiopathic Pulmonary Fibrosis
MORRISTOWN, N.J., Aug. 5, 2014 /PRNewswire/ -- Moerae Matrix, Inc. announced today the initiation of a Phase 1 clinical trial of MMI-0100, a first-in-class inhibitor of MAPKAP Kinase 2 (MK2) being developed for the treatment of idiopathic pulmonary fibrosis (IPF) and other diseases characterized by inflammation and fibrosis. The Phase 1 study is being conducted in the Netherlands and will evaluate the safety, tolerability and pharmacokinetics of ascending doses of MMI-0100 when given via inhalation to healthy volunteers.
MMI-0100 is a cell-permeant peptide inhibitor of MK2, a critical downstream target within the TGF-B pathway that, when dysregulated, stimulates and worsens inflammation and fibrosis. In gold standard preclinical models of pulmonary fibrosis and other fibrotic disorders, MMI-0100 has shown significant efficacy in both preventing scarring and fibrosis and treating established fibrosis. The drug has demonstrated a favorable safety and tolerability profile preclinically, and its unique mechanism of action offers a potential treatment for a number of fibrotic and inflammatory disorders. Moerae is first developing MMI-0100 for treatment of IPF, a chronic and progressive fibrotic disease of the lung.
"This first-in-human Phase 1 MMI-0100 study represents a significant milestone in achieving Moerae's corporate goal of developing novel, safe and effective compounds to alleviate suffering for the hundreds of thousands of patients worldwide who are afflicted with IPF and other fibrotic disorders," said Cynthia Lander, PhD, Chief Executive Officer of Moerae. "We are particularly encouraged by our animal model data demonstrating that MMI-0100 is capable of not only preventing but also treating fibrosis, as patients generally already have significant tissue damage by the time they are diagnosed."
Paul Noble, MD, Chairman of Medicine, Cedars-Sinai Medical Center, stated, "We are entering a new era in the treatment of patients suffering from IPF. The future of IPF treatment will require multiple drugs designed to target different components of the disease process. MMI-0100 is a novel inhibitor of MK2, which is a pathway that is critical for the development of pulmonary fibrosis. Administration of MMI-0100 by inhalation provides a mechanism to deliver drug directly to target lung tissue, thereby minimizing potential side effects associated with systemic delivery, whether MMI-0100 is given alone or as part of a combination drug therapy regimen. These first-in-human studies are an exciting step towards determining if this approach can help patients with IPF."
IPF is a fatal, chronic, progressive, fibrosing, interstitial pneumonia of unknown cause with a mean survival of five years from time of first diagnosis. In the United States, IPF is estimated to affect between 132,000-200,000 people, and as many as 40,000 people die from the disease each year.
About Moerae Matrix, Inc.
Moerae Matrix is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative therapies for patients suffering from inflammatory and fibrotic disorders. Moerae's leadership team, scientific advisors and research collaborators are at the forefront of fibrotic and inflammatory disease research. In addition to MMI-0100, Moerae has a pipeline of cell permeant peptide drug candidates being investigated for various diseases characterized by inflammation and fibrosis (e.g., cardiac and vascular remodeling, surgical scarring, respiratory diseases and dermatology). The Company is supported by private investors and significant grant funding.
SOURCE Moerae Matrix, Inc.