4D pharma Presents Late-Breaking Abstract From Phase 1/2 Trial of MRx-4DP0004 for the Treatment of Asthma

4D pharma plc recently announced the presentation of a late-breaking poster on data from Part A of the Phase 1/2 trial of MRx-4DP0004 for the treatment of asthma. The poster was presented at the 2022 American Thoracic Society (ATS) International Conference, May 13-18, 2022, in San Francisco, CA.

“The clinical results of MRx-4DP0004 treatment to date reinforce 4D pharma’s success in using the MicroRx platform to select single strain LBPs and generate clinical candidates with specific immune-modulating therapeutic functionality. We are proud to share with the asthma medical community our growing body of data supporting the potential of MRx-4DP0004 as a novel oral treatment for asthma. 4D pharma will further bolster these results as we advance the Phase 1/2 trial into Part B,” said Dr. Alex Stevenson, Chief Scientific Officer of 4D pharma. “The effects of MRx-4DP0004 improving ACQ scores and reducing patients’ reliance on SABA rescue medication are very encouraging. Moving forward into the Part B phase of this trial, 4D pharma aims to evaluate MRx-4DP0004 in asthma patients with more symptomatic disease, expected to provide a greater opportunity to demonstrate improvements.”

The company previously announced topline safety and efficacy data from Part A of the trial, in addition to disclosing that this portion of the trial met the primary endpoint of safety and tolerability. In a late-breaking abstract and poster presentation titled, Safety, Tolerability and Preliminary Signals of Activity in Adult Patients with Partly Controlled Asthma Treated with Live Biotherapeutic MRx-4DP0004 as an Add-On Maintenance Therapy to Inhaled Corticosteroids (ICS) With or Without Long-Acting Beta Agonists (LABA), 4D highlighted key safety and efficacy findings:

Safety

• MRx-4DP0004 was safe and well-tolerated with no treatment-related severe adverse events (AEs) or serious AEs reported.
• The frequency of AEs and treatment discontinuations due to AEs were comparable to placebo.

Efficacy

• A significantly greater proportion of patients receiving MRx-4DP0004 than those receiving placebo experienced a reduction in Asthma Control Questionnaire (ACQ-6) scores from baseline at all time points. At end of treatment 83.3% of subjects receiving MRx-4DP0004 had improved ACQ-6 scores compared to 56.3% of those receiving placebo, p equal to 0.088.
• The proportion of MRx-4DP0004-treated patients with improved ACQ-6 scores increased over the treatment period.
• A greater proportion of the MRx-4DP0004 arm than the placebo arm experienced a reduction in total weekly use of short-acting beta agonists (SABA) rescue medication at all time points.
• At the end of treatment period (day 85), 50% of patients receiving MRx-4DP0004 reduced their use of SABA rescue medication as compared to 18.8% percent for patients receiving placebo.
• At the end of treatment period (day 85), 50% of patients receiving MRx-4DP0004 experienced clinically meaningful improvements in Asthma Quality of Life Questionnaire (AQLQ) scores of greater than or equal to 0.5 from baseline, compared to 31.3% of patients receiving placebo.
• In the 12-week treatment period, there was one instance of asthma exacerbation in the MRx-4DP0004 treatment arm, compared to two instances in the placebo arm.
• Mean measures of lung function remained stable from baseline and throughout the treatment period, determined by forced expiratory volume (FEV1), ratio FEV1:forced vital capacity (FVC) and peak expiratory flow (PEF).

The Phase 1/2 trial of MRx-4DP0004 is now progressing into Part B, which will assess clinical and biomarker activity in up to 90 adult patients with partly controlled asthma. Following the successful conclusion of Part A, 4D pharma intends to enroll patients into Part B of the study who are more symptomatic than those enrolled in Part A. 4D pharma expects the more symptomatic patients to give even greater scope for treatment effects to be observed. The primary endpoint of Part B will be the proportion of patients with a reduction in ACQ-6 scores from baseline vs. placebo, which was statistically significant at all time points evaluated in Part A of the trial.

4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D pharma has developed a proprietary platform, MicroRx, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.

4D pharma’s Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The company has five clinical programs, namely a Phase 1/2 study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in solid tumors, a Phase 1 study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase 1 study of MRx0518 in patients with pancreatic cancer, a Phase 1/2 study of MRx-4DP0004 in asthma, and Blautix in irritable bowel syndrome (IBS) which has completed a successful Phase 2 trial. A Phase 1 study of MRx0005 and MRx0029 in patients with Parkinson’s disease is expected to commence in 2022. Additional preclinical-stage programs include candidates for CNS disease, immune-inflammatory conditions and cancer. The company has a research collaboration with MSD (Merck and Co., Inc., Kenilworth, NJ), to discover and develop Live Biotherapeutics for vaccines.