Safety and efficacy data for the oral asthma therapy was presented at a late-breaking session at ATS 2022.
A new investigation into the novel oral asthma therapy MRx-4DP0004 found it to be safe and well tolerated in patients with asthma when paired with inhaled corticosteroids (ICS) with or without long-acting beta-agonist (LABA).
Part A of this investigation was detailed at the American Thoracic Society 2020 International Conference in San Francisco.
Previous data has shown that the novel, gut microbiome-derived, oral, single strain Live Biotherapeutic Product (LBP) was effective in reducing lung infiltration of neutrophils and eosinophils, lung inflammatory scores, tissue damage, and more in animals models of severe asthma.
Currently, the therapeutic is being evaluated in human adults with partly controlled asthma as an add-on maintenance therapy via a 2-part phase 1 and 2 study.
For their ATS 2022 session, study author Christopher Brightling, PhD, of the University of Leicester, presented safety and efficacy data from Part A of the study.
Following a 2-week placebo run-in period, Brightling and colleagues randomized 34 patients to receive MRx-4DP0004 2 capsules PO BID (1x109 to 1x1010 CFU) or placebo in addition to their regular maintenance asthma medication of ICS with or without LABA for up to 12 weeks or until withdrawal.
Eligible patients were those with partly controlled asthma, and the primary endpoint of Part A of the study was safety and tolerability of the oral therapy. Meanwhile, secondary endpoints were asthma controls and exacerbations.
Overall, the therapy was well-tolerated among patients in the treatment group, and the frequency of adverse events and treatment discontinuations were similar to placebo.
Notably, all adverse events were mild and moderate, and no treatment-related serious adverse events were reported.
Investigators observed that a significantly greater proportion of patients receiving MRx-4DP0004 experienced improvements in their ACQ-6 from baseline compared to placebo, with a reduced ACQ-6 scores being present In 83.3% of patients treated with the therapy compared to 56.3% of those in the placebo group (P=0.088).
Additionally, 50.0% of patients receiving MRx-4DP0004 reduced their total weekly use of SABA rescue medication from baseline, compared to 18.8% for placebo by the end of treatment (P=0.06), and 50% of patients receiving the therapy had also experience clinically meaningful improvements in AQLQ score from baseline of ≥0.5.
Only one asthma exacerbation was recorded in the MRx-4DP0004 treatment arm, compared to 2 in the placebo arm.
“MRx-4DP0004 is a potential novel oral asthma therapy that is safe and well-tolerated in asthma patients in addition to ICS±LABA,” the team wrote. “Part A of the study generated preliminary signals of clinical activity compared to placebo. Part B of the study will assess clinical and biomarker activity.”