4D pharma Announces Publication of Preclinical Research Showing Live Biotherapeutic MRx0006 Efficacy in Animal Model of Autism Spectrum Disorder
Leeds, UK, August 24, 2022 – 4D pharma plc (AIM: DDDD) , a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces the publication of pre-clinical research relating to its LBP MRx0006 for the treatment of autism spectrum disorder (ASD).
The research, published in Brain, Behaviour and Immunity, demonstrates the ability of single strain LBP MRx0006 to attenuate core behavioural deficits in a mouse model of autism, improving social deficits, repetitive and anxiety-like behaviours. Mechanistically, MRx0006 increased in the brains of ASD mice the expression of neuropeptide hormones known to regulate social and anxiety behaviour. MRx0006 also modulated the fecal microbiome metabolite profile in treated mice, which may underly the observed increases in expression of neuropeptides and their receptors, and the consequent improvements in behavioural outcomes.
“The publication of this research illustrates the continued productivity of 4D pharma’s MicroRx platform, and further establishes 4D pharma as a pioneer in expanding the application of live biotherapeutics to conditions of the gut-brain axis,” commented Dr. Imke Mulder, Research Director, 4D pharma. “People with autism spectrum disorder and their families are in need of new treatment approaches, and the microbiome-gut-brain axis is increasingly recognized as a key target. Importantly, with this research we are moving the field beyond associations to demonstrate the meaningful impacts that can be achieved by a single strain of bacteria, and identifying mechanisms through which the gut microbiome influences the central nervous system and behaviour.”
“To our knowledge MRx0006 is the first live biotherapeutic to demonstrate the ability to target all three core behavioural deficits central to ASD, representing a novel therapeutic strategy,” commented Dr Alex Stevenson, Chief Scientific Officer, 4D pharma. “Adding to our previous work in conditions of the central nervous system such as Parkinson’s disease, these results further confirm the potential of human microbiota-derived therapeutics in supporting mental health by modulating the microbiota-gut-brain axis.”
Sen et al., ‘The live biotherapeutic Blautia stercoris MRx0006 attenuates social deficits, repetitive behaviour, and anxiety-like behaviour in a mouse model relevant to autism’ Brain, Behaviour and Immunity, 2022, in press https://doi.org/10.1016/j.bbi.2022.08.007
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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