4D Pharma plc (AIM: DDDD), a Leading Pharmaceutical Company in the Development of Live Biotherapeutic Products (PBV), today announced an enhanced version of MRx-4DP0004, its leading PBV candidate for the treatment of asthma.
A multi-center, double-blind, placebo-controlled Phase I / II study of MRx-4DP0004 in poorly controlled asthmatic patients has now begun. The study will include 90 asthma patients who are not adequately controlled with their inhaler maintenance treatment. Patients will take MRx-4DP0004 in addition to their maintenance treatment. This is the first clinical study in the world on a living biotherapeutic product in poorly controlled asthma patients. The results of this study should be available in 2020.
The primary endpoints of this study are the safety and tolerability of MRx-4DP0004 when combined with long-term maintenance therapy. Secondary endpoints include reducing asthma symptoms, exacerbations, hospitalizations, and improving asthma control. The principal investigator of this study is Professor Chris Brightling, from the University of Leicester.
This study is based on data published by 4D (Raftis et al., Scientific Reports 2018) demonstrating that MRx-4DP0004 can significantly reduce the infiltration of neutrophils and eosinophils into the respiratory tract and surpass treatment. classics in a preclinical model of severe asthma resistant to steroids.
Alex Stevenson, Scientific Director of 4D, said, “The launch of this study underscores 4D’s commitment to fully unlocking the potential of the gut microbiome and live biotherapeutics to treat diseases beyond the gastrointestinal tract. intestinal. This year, we expanded our pipeline of clinical developments to evaluate PBVs with diseases anatomically distant from the gut, first in oncology and now with asthma. ”
He added: “Despite the available treatments, many asthmatic patients have difficulty controlling their disease and suffer from exacerbations that often require hospitalization. The results of this study will provide important proof of concept for the development of live biotherapeutic products as a next generation therapy in asthma management. ”
Founded in February 2014, 4D is a global leader in the development of living biotherapeutics, an emerging and emerging class of drugs, defined by the FDA as biologics containing a living organism, such as a bacterium, for use in treatment or cure of a disease. 4D has created a proprietary platform that rationally identifies new bacteria through a thorough understanding of function and mechanisms. All 4D live biotherapeutic products are unique oral bacterial strains that are naturally present in a healthy human gut. 4D is currently conducting four clinical studies, a phase II study on Blautix in irritable bowel syndrome, a combined phase I / II study on MRx0518 in combination with Keytruda® (pembrolizumab) in solid tumors, a phase study I on MRx0518 as neo-adjuvant therapy in patients with solid tumors and a phase I / II study of MRx-4DP0004 in asthmatic patients. Other targeted programs focus on therapeutic areas such as CNS diseases.
Asthma is an inflammatory disease of the lungs characterized by recurrent symptoms, reversible airway obstruction and bronchospasm. Between 5% and 10% of asthmatic patients have the severe form of the disease, refractory to steroid treatment, impossible to control with high intensity treatments and accounting for more than 50% of health care costs associated with asthma . There is a growing body of evidence linking the intestinal microbiome to the development of asthma. The Therapeutic Asthma Drug Market is expected to reach $ 23.1 billion by 2023
In severe asthma, airway inflammation may be predominantly neutrophilic, eosinophilic or mixed. Although a number of biologics have recently been approved to treat patients with eosinophilic disease, there is currently no approved treatment for patients with a neutrophil phenotype.
MRx4DP0004 has demonstrated strong and significant efficacy in standard preclinical models of severe steroid-resistant asthma. It has been shown to reduce both neutrophils and eosinophils in both prophylactic and therapeutic settings. Its effectiveness has also resulted in a reduction in histopathological inflammation of the lung and specific subsets of T cells and dendritic cells.
In particular, MRx4DP0004 outperformed the positive anti-IL-17 control in this model and was able to simultaneously reduce neutrophils and eosinophils in the respiratory tract, which is not achievable with existing treatments. Added to standard maintenance therapy such as inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), MRxDP0004 may be beneficial for partially controlled asthma patients.
SOURCE 4D pharma plc
More information please visit: https://www.4dpharmaplc.com