Leeds, UK, May 17, 2022 – 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces the presentation of a late-breaking poster on data from Part A of the Phase I/II trial of MRx-4DP0004 for the treatment of asthma. The poster is being presented at the 2022 American Thoracic Society (ATS) International Conference, May 13-18, 2022 in San Francisco, CA, US.
“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 I/II 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:
- 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.
- 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=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% 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 ≥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 I/II 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.
About 4D pharma
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 I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and Blautix® in irritable bowel syndrome (IBS) which has completed a successful Phase II trial. A Phase I 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 & Co., Inc., Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics for vaccines.
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This announcement contains "forward-looking statements." All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding the efficacy of Live Biotherapeutics including MRx-4DP0004, use of the MicroRx® platform to identify candidates, and the Company's next steps and progression of the Phase I/II study, are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements are often identified by the words "believe," "expect," "anticipate," "plan," "intend," "foresee," "should," "would," "could," "may," "estimate," "outlook" and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company's current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.
All of the Company's forward-looking statements involve known and unknown risks and uncertainties, some of which are significant or beyond its control, and assumptions that could cause actual results to differ materially from the Company's present expectations or projections. The foregoing factors and the other risks that could cause actual results to differ materially include risks relating to the efficacy of its Live Biotherapeutic drug candidates including MRx-4DP0004, the risk that the Company changes its expected strategy and plans, risk related to safety of investigational therapeutics, clinical development risk, and those additional risks and uncertainties described in the documents filed by the Company with the US Securities and Exchange Commission ("SEC"). The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of its forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law.