View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
February 23, 2022

4D Pharma to start Phase I Parkinson’s disease trial of biotherapeutic assets

The company anticipates commencing a Phase I trial in Parkinson’s disease patients mid-year.

4D Pharma secured the approval of the US Food and Drug Administration (FDA) to initiate a Phase I clinical trial for its two live biotherapeutics (LBPs) to treat Parkinson’s disease.

The company anticipates commencing the first-in-human Phase I clinical trial of the LBPs named MRx0005 and MRx0029 in Parkinson’s disease patients mid-year.

The randomised, multicentre, placebo-controlled, double-blind trial will analyse the safety and tolerability of MRx0005 or MRx0029 in different arms enrolling Parkinson’s disease patients.

Apart from safety, the trial will analyse biomarkers linked to the candidate LBPs’ mechanisms of action.

Delivered orally, the LBPs are single strains of bacteria seen in the healthy human gut.

MRx0005 and MRx0029 are being developed to treat neurodegenerative ailments such as Parkinson’s disease through the gut-brain axis.

Discovered using MicroRx platform of 4D Pharma, they demonstrated to lower neuroinflammation, including inflammation caused by α-synuclein and to prevent oxidative stress-induced death of neurons in pre-clinical studies.

In vivo, MRx0005 showed to upregulate neuroactive molecules and their receptors’ expression. It could also offer protection against dopamine metabolite loss in the brains of mice with induced parkinsonian syndrome. 

MRx0029 was found to elicit dopaminergic neuronal phenotype differentiation in vitro and offer protection against dopaminergic neuron loss in the Parkinson’s disease animal model. 

4D pharma has formed a Patient Advisory Board (PAB) consisting of Parkinson’s patients in partnership with Parkinson’s UK.

The PAB is supported by Parkinson’s UK and offers 4D pharma a patient-centric perspective as it develops its new LBPs into clinical trials for treating neurodegenerative diseases such as Parkinson’s.

4D pharma chief scientific officer Dr Alex Stevenson said: “We believe MRx0005 and MRx0029 are the first-ever Live Biotherapeutic products for Parkinson’s to enter the clinic.

“We believe that our LBPs MRx0005 and MRx0029, which each have different mechanisms of action worthy of investigation, provide a unique opportunity to address the high unmet needs of those living with Parkinson’s disease.”

In January 2020, the company commenced a trial to analyse the initial clinical efficacy of MRx0518 plus preoperative radiotherapy to treat resectable pancreatic cancer.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU