Moerae Matrix Inc. announced today the initiation of its second Phase 1 clinical trial with MMI-0100, a first-in-class inhibitor of MAPKAP kinase 2 (MK2) that is being developed for pulmonary disorders characterized by inflammation and fibrosis. The study, conducted in the United Kingdom, is a double-blind, two-way cross-over design lipopolysaccharide (LPS) challenge study further evaluating the safety and tolerability of MMI-0100 when given via inhalation to healthy subjects who smoke. The effect of MMI-0100 on biomarkers of inflammation will also be explored.
MMI-0100 is a novel, cell-permeant peptide inhibitor of MK2, a downstream kinase within the TGF-Beta pathway. MK2 is an important mediator of both inflammation and fibrosis. MMI-0100 has demonstrated broad evidence of preclinical efficacy in multiple animal models of inflammation and fibrosis. These models include organ inflammation and fibrosis (pulmonary, cardiac, and vascular), as well as prevention of scar and adhesion formation in acute surgical models. These collective preclinical results provide a strong rationale to explore treatment with MMI-0100 in a variety of pulmonary disorders, including both obstructive and fibrotic lung diseases.
MMI-0100 delivered by inhalation to healthy subjects was safe and well tolerated in the recently completed Phase 1 single ascending dose study. Forty-eight subjects participated in the study that interrogated 7 dose levels of MMI-0100. No drug-related grade 3 or 4 adverse events, serious adverse events, or dose-limiting toxicities were reported.
Moerae's Chief Medical Officer, Bill Bradford, said, "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."