4D pharma plc, a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces that the U.S. Food and Drug Administration (FDA) has cleared investigational new drug (IND) applications for two Live Biotherapeutics (LBPs), MRx0005 and MRx0029, for the treatment of Parkinson’s disease. The Company expects to initiate a first-in-human Phase I clinical trial in people with Parkinson’s disease in mid-2022.

“Entering the clinic with our novel CNS programs stemming from our proprietary MicroRx platform will represent an important step for 4D pharma’s continued growth and leadership in the microbiome field. We believe MRx0005 and MRx0029 are the first ever Live Biotherapeutic products for Parkinson’s to enter the clinic,” said Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. “Current treatments focus on symptoms but do not address the underlying causes of neurodegeneration. Patients and clinicians are in need of new, more effective treatment options, and the gut-brain axis is an exciting area of innovation with the potential to change the way we approach Parkinson’s treatment. 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.”

“Parkinson’s disease is a devastating condition impacting more than 10 million people globally. As the global population ages, this number will continue to increase. There is growing evidence suggesting that the gut-brain axis could be key to developing new treatments for several neurological disorders, particularly Parkinson’s disease,” said Professor Peter LeWitt, Sastry Foundation Endowed Chair in Neurology at Wayne State University School of Medicine, and Coordinating Investigator of the Phase I clinical trial. “Oral, gut-targeted treatments such as 4D pharma’s Live Biotherapeutics MRx0005 and MRx0029 offer an exciting new way for possibly slowing Parkinson’s disease progression. The development of these potential new therapies is really breaking new ground in the field.”

MRx0005 and MRx0029 are two unique single strain Live Biotheraputic candidates, which have been shown pre-clinically to have positive impacts on multiple key aspects of Parkinson’s disease pathology, including gut barrier integrity, neuroinflammation, oxidative stress and neuroprotection. In animal models of Parkinsonian syndrome, 4D pharma demonstrated that MRx0005 and MRx0029, respectively protected against the loss of dopamine metabolites and dopamine-producing neurons in the brain.

4D pharma expects to initiate a Phase I clinical trial in mid-2022. The multi-center, randomized, double-blind, placebo-controlled study will evaluate the safety and tolerability of MRx0005 or MRx0029 in separate cohorts of patients with Parkinson’s disease. In addition to safety, the study will measure biomarkers relating to the mechanisms of action of the candidate LBPs.

4D pharma is collaborating with Parkinson's UK, a non-profit organization focused on advancing the understanding of Parkinson's disease and improving treatments, and has established a Patient Advisory Board (PAB) comprised of people living with Parkinson's. Supported by Parkinson's UK, the PAB provides a valuable patient-centric perspective to 4D pharma as it advances its novel Live Biotherapeutics into the clinic to treat neurodegenerative conditions such as Parkinson's. The PAB will also focus on raising awareness of the issues people with Parkinson's face with current treatment options. In addition, 4D pharma is an Industry Partner of the Parkinson's Progression Markers Initiative (PPMI), a landmark study sponsored by The Michael J. Fox Foundation to better understand Parkinson's disease and to identify, develop, and validate biomarkers of Parkinson's disease progression to further the development of disease-modifying therapies.