CJRB-301 / 4D Pharma, CJ Biosci - LARVOL DELTA

Revolutionary new class of therapeutics derived from the human gut microbiome displaying neuromodulatory properties could offer a promising treatment for Parkinson's disease (Neuroscience 2022) - "These findings potentially indicate that in the not-too-distant future, diseases of the central nervous system (CNS) may be treated by therapeutics derived from living gut bacteria. 4D pharma is continuing to build on research into the gut-brain axis and gut-targeted LBPs such as MRx0005 and MRx0029 offer a promising new way to treat neurodegenerative disorders such as PD."

CNS Disorders • Parkinson's Disease

4D pharma Reports Full Year 2021 Financial Results, Operational Highlights, and Guidance for Key Milestones in 2022 (Businesswire) - "4D pharma plc...today reported financial results for the full year ending December 31, 2021 and highlighted its key corporate objectives for 2022....Phase I trial of MRx0005 and MRx0029 in people with Parkinson’s disease expected to commence in 2H 2022..."

New P1 trial • Trial initiation date • CNS Disorders • Parkinson's Disease

FDA Action Update, February 2022: Approvals, Resubmissions, Application Clearances (NeurologyLive) - '"Parkinson 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 disease,' Peter LeWitt, MD...and coordinating investigator of the phase 1 trial, said at the time of the announcement. '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.'"

Media quote

4D pharma announces FDA clearance of IND application for Live Biotherapeutics MRx0005 and MRx0029 for the treatment of Parkinson’s disease (4D pharma Press Release) - "4D pharma plc...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....'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..."

Announcement • Media quote

4D pharma Announces FDA Clearance of IND Application for Live Biotherapeutics MRx0005 and MRx0029 for the Treatment of Parkinson’s Disease (Businesswire) - "4D pharma plc...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....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."

IND • New P1 trial • CNS Disorders • Parkinson's Disease