4D Pharma, Treating Gut Microbiota, Joins Parkinson’s Biomarker Study

4D Pharma, a biotechnology company focused on gut microbiota-based therapies, has joined the Parkinson’s Progression Markers Initiative (PPMI), an observational study helping to identify biomarkers of Parkinson’s progression and new ways of treating the disease. 

Gut microbiota — a vast community of friendly bacteria, fungi, and viruses that colonize the gastrointestinal tract — work to maintain a healthy and balanced gut environment, protect against disease-causing organisms, and influence a person’s immune system and inflammatory responses.

Increasing evidence supports gut microbiota as a potential contributor to Parkinson’s, with patients showing an imbalance in gut microbiota, with some of these changes associated with early risk markers.

The partnership will take advantage of 4D Pharma’s expertise in live biotherapeutics, a new class of therapies defined as biological products containing whole, live microorganisms, such as a bacteria or yeast, aimed at preventing, treating, or curing a disease.

4D Pharma will join the partner scientific advisory board of PPMI — funded by the Michael J. Fox Foundation (MJFF) and a consortium of industry players, nonprofit organizations, and private individuals — which is closely involved in the study’s design and execution. It will also join a variety of working groups that provide a forum to discuss PPMI data, and address Parkinson’s clinical trial challenges with other PPMI partners.

Launched in 2010, the PPMI study (NCT01141023) is collecting clinical and biological data from more than 1,400 participants over time to measure and track disease risk, onset, and progression, and to establish new biomarkers for use in Parkinson’s clinical trials.

The study now comprises the largest dataset ever compiled for Parkinson’s disease research, and is expanding to include more than 4,000 participants, recruited at over 50 clinical sites in 13 countries.

“It is only with diverse expertise on the various aspects of this complex disease that we will better understand it and find solutions for patients,” Sohini Chowdhury, MJFF’s deputy CEO, said in a press release.

“We are pleased to welcome 4D pharma as a partner on the Parkinson’s Progression Markers Initiative,” Chowdhury added, as “there is a significant and growing interest in the field in understanding the role of the [gut microbiota] in Parkinson’s disease and opportunities for therapeutic intervention.”

Company representatives bring “expertise in this novel area of research to our Scientific Advisory Board, and we look forward to their insights and contributions,” Chowdhury said.

Alex Stevenson, 4D Pharma’s chief scientific officer, added that the company “will play an important role as PPMI considers the microbiome as an area of focus, following a growing body of evidence pointing to the gut microbiome as a new frontier in our understanding and treatment of Parkinson’s disease.” 

This forum allows its partners “to share our knowledge and scientific approach and to help shape the future of high-quality research into Parkinson’s disease and other neurodegenerative conditions, while continuing to learn from leading experts in the field across industry, academia and non-profit organisations,” Stevenson added.

In addition to its contribution to PPMI, 4D Pharma is planning to open a clinical trial to evaluate live biotherapeutics in Parkinson’s patients — the first of its kind. The decision is based on preclinical data highlighting the neuroprotective effects of its two Parkinson’s therapy candidates — MRx0005 and MRx0029 — in a mouse model of the disease.

The company’s live biotherapeutics are orally delivered single strains of bacteria that are naturally found in the healthy human gut. Potentially beneficial strains are identified based on an understanding of their function and mechanism through MicroRx, a proprietary screening platform.

Besides neurodegenerative conditions, the company is working on the development of live biotherapeutics for several types of cancer and respiratory diseases, including COVID-19.