4D pharma plc announced positive topline results from Part A of phase I/II clinical trial of MRx-4DP0004, an orally-delivered single strain Live Biotherapeutic being developed for the treatment of asthma. The Phase I/II trial is a multi-center, double-blind, placebo-controlled study in patients with partly controlled asthma taking long-term medication. The primary endpoint of Part A was to evaluate the safety and tolerability of MRX-4DP0004 with secondary endpoints evaluating clinical activity. Part A met the primary endpoint and the safety profile of MRx-4DP0004 was comparable to placebo. No serious adverse events (SAEs) related to treatment were reported. In addition to the achieving the primary endpoint, MRx-4DP0004 generated promising signals of clinical activity, which supports progression into Part B of the study. Part B is expected to enroll up to 90 patients, informed by the clinical signals identified in Part A. Trial overview and Topline Results from Part A: Part A enrolled 34 patients, randomized 1:1 to receive oral MRx-4DP0004 or placebo twice daily for 12 weeks, in addition to their usual maintenance therapy of inhaled corticosteroids (ICS) with or without long-acting beta agonist (LABA). Part A of the study was not powered for statistical significance and 29 patients were evaluable for secondary endpoints of clinical activity. MRx-4DP0004 achieved the primary endpoint of safety and tolerability in combination with ICS and LABA. The safety profile of MRx-4DP0004 was comparable to placebo and no serious adverse events (SAEs) related to treatment were reported. A greater proportion of patients receiving MRx-4DP0004 reduced their dependence on short-acting beta agonist (SABA) rescue medication compared to placebo. Reduced SABA use is a key indicator of improved asthma control. A greater proportion of patients receiving MRx-4DP0004 had a clinically meaningful increase in Asthma Quality of Life Questionnaire (AQLQ) scores of =0.5 at end of treatment, compared to placebo. MRx-4DP0004 achieved a greater mean change from baseline in ACQ-6 score than placebo at end of treatment. ACQ-6 is a well-established and widely used scale to measure asthma control. In addition, at end of treatment, a greater proportion of patients receiving MRx-4DP0004 experienced clinically meaningful reductions from baseline in ACQ-6 scores of =0.5, than in the placebo arm - Two of 16 patients randomized to placebo experienced asthma exacerbations, compared to one of 18 patients randomized to MRx-4DP0004.