US-based biopharmaceutical firm Moerae Matrix has started a Phase I clinical trial of MMI-0100, a first-in-class inhibitor of MAPKAP Kinase 2 (MK2) developed to treat idiopathic pulmonary fibrosis (IPF) and other diseases characterised by inflammation and fibrosis.
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.
The Phase I trial, taking place in the Netherlands, is designed to assess the safety, tolerability and pharmacokinetics of ascending doses of MMI-0100 when given through inhalation to healthy volunteers.
The company said that in gold standard preclinical models of pulmonary fibrosis and other fibrotic disorders, MMI-0100 has showed significant efficacy in both preventing scarring and fibrosis and treating established fibrosis.
Pre-clinically, the drug has showed a favourable safety and tolerability profile. Its unique mechanism of action provides a potential treatment for a number of fibrotic and inflammatory disorders.
Moerae chief executive officer Cynthia Lander said: "This first-in-human Phase I 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.
"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."
IPF is a fatal, chronic, progressive, fibrosing, interstitial pneumonia of unknown cause. Patients have a mean survival of five years from the time of their first diagnosis.
In the US, between 132,000-200,000 people are expected to be affected by IPF, and about 40,000 people die from the disease each year.
Cedars-Sinai Medical Center chairman of Medicine Paul Noble said: "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 minimising 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."
Image: Clubbing of the fingers in Idiopathic Pulmonary Fibrosis (IPF). Photo: courtesy of IPFeditor.