4D pharma plc announced 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. 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.