4D Pharma Commences Ph 1/II Asthma Trial
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces an update on its lead Live Biotherapeutic candidate for asthma, MRx-4DP0004.
A multicentre Phase I/II double-blind, placebo-controlled study of MRx-4DP0004 in patients with poorly controlled asthma has now commenced. The study will enrol 90 asthma patients not adequately controlled on their current inhaler maintenance therapy. Patients will take MRx-4DP0004 in addition to existing maintenance therapy. This is the world’s first clinical study of a Live Biotherapeutic in patients with poorly controlled asthma. It is anticipated that the results of this study will be available in 2020.
The primary endpoints of this study are safety and tolerability of MRx-4DP0004 when added to long-term maintenance therapy, with secondary endpoints including reduction of asthma symptoms, exacerbations, hospitalisations and the achievement of improved asthma control. The principal investigator for this study is Prof. Chris Brightling, University of Leicester.
This study builds on 4D’s published data (Raftis et al., Scientific Reports 2018) demonstrating that MRx-4DP0004 can significantly reduce both neutrophil and eosinophil airway infiltration concurrently and outperformed standard therapeutics in a preclinical disease model of severe steroid-resistant asthma.
Alex Stevenson, 4D’s Chief Scientific Officer, commented: “Commencing this study further underlines 4D’s commitment to unlocking the full potential of the gut microbiome and Live Biotherapeutics or ‘LBPs’ to treat diseases beyond the gastrointestinal tract. This year, we have expanded our clinical pipeline to evaluate LBPs in diseases anatomically distant from the gut, firstly in oncology, and now in asthma.”
Infant Bacterial Therapeutics recruits first patient in the pivotal Ph III study of IBP-9414 in Necrotizing Enterocolitis
IBT has recruited the first patient in the Phase III pivotal clinical study, The Connection Study. The development program for IBP-9414, of which The Connection Study is the final planned clinical study, has now been agreed with both FDA and EMA. The study is randomized, double blind and placebo controlled to evaluate the safety and efficacy of IBP-9414 with respect to the prevention of necrotizing enterocolitis and other clinically important aspects of feeding preterm babies. The study is designed to include 2158 premature infants with a birth weight of 500-1500 grams and will be conducted at about 100 hospitals in the US, Europe and Israel.
IBP-9414 contains the active Lactobacillus reuteri,
The first patient was recruited today, July 4th, and the clinical trial applications have been approved in the United Kingdom, France, Hungary and Spain in addition to the IND that is now open in the United States. This means that IBT expects patients to be included in additional countries in the very near future.