Moerae Matrix Inc. recently announced the start of a second Phase 1 clinical trial with MMI-0100, a therapeutic drug developed for pulmonary disorders associated with fibrosis and inflammation, as is the case with idiopathic pulmonary fibrosis (IPF).
IPF is a progressive fatal lung disease in which the alveoli and the lung tissue are damaged, becoming thick and scarred (fibrosis), leading to severe breathing difficulties and compromising oxygen transfer between the lungs and the bloodstream. The disorder is characterized by a shortness of breath that gradually worsens, with respiratory failure being the main cause of death. IPF has a poor prognosis and around two-thirds of patients succumb to the disease within five years after being diagnosed. It has no cure and it is estimated that almost 130,000 individuals in the United States and 5 million worldwide suffer from the disease.
Moerae’s MMI-0100 is a cell-permeant inhibitor of MAPKAP kinase 2 (MK2), a protein involved in several cellular processes, being an important mediator of both inflammation and fibrosis. MMI-0100 has been shown to be effective in reducing organ inflammation and fibrosis, and also in preventing scarring in several animal models.
The new Phase 1 clinical trial will be conducted in the United Kingdom, and it is a double-blind, lipopolysaccharide (LPS) challenge study where healthy individuals who smoke will receive MMI-0100 via inhalation in order to evaluate its safety and tolerability. The LPS challenge evaluates the person’s ability to respond to an inflammatory stimulus by mounting an immune response. The team will also assess the impact of MMI-0100 treatment on biomarkers of inflammation.
MMI-0100 delivered through inhalation has been recently found in another Phase 1 trial to be safe and well-tolerated by healthy individuals. In total, 48 patients were enrolled on the trial and seven different MMI-0100 dose levels were tested. No mild or serious adverse events or dose-limiting toxicities were reported in the study.
“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.” concluded the Chief Medical Officer of Moerae, Dr. Bill Bradford in a news release.