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.

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By GlobalData

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.