Moerae Matrix Inc., a privately held biopharmaceutical company focused on the development of first-in-class targeted therapeutics for fibrotic diseases, recently announced the initiation of its second Phase 1 clinical trial of MMI-0100 for the treatment of pulmonary conditions characterized by fibrosis and inflammation.
The study is a double-blind, two-way cross-over design lipopolysaccharide (LPS) challenge clinical trial that is examining the tolerability and safety of the drug agent when inhaled by healthy individuals who smoke. The study will also explore the effect of the drug in inflammation biomarkers.
MMI-0100 is a first-in-class inhibitor of MAPKAP kinase 2 (MK20), a downstream kinase within the TGF-Beta pathway. MK2 is known to mediate fibrosis and inflammation.
The experimental therapy has already been shown to be effective in several animal models in treating fibrosis and inflammation. These models involved cardiac, vascular and pulmonary inflammation and fibrosis, and also the prophylaxis of scar and adhesion formation in acute surgical models.
According to the company, these results derived from preclinical trials opened up the potential for the drug to be used in pulmonary disorders, including both obstructive and fibrotic lung diseases.
Results from a Phase 1 single ascending dose clinical trial showed that MMI-0100 delivered by inhalation was safe and well tolerated. In the study, a total of 48 participants tested 7 dose levels of MMI-0100. Participants did not report any adverse or serious events or toxicity.
Moerae’s Chief Medical Officer, Bill Bradford, said in a recent news release, “The encouraging safety and tolerability results from the recently completed single ascending dose study coupled with the strong anti-inflammatory and anti-fibrotic activity observed in a variety of preclinical animal models provide a strong foundation for advancing MMI-0100 in the clinic. The now-ongoing LPS challenge study will inform the next steps as we move towards studying patients with pulmonary disease.”