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.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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 Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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

Thank you for subscribing to Clinical Trials Arena