The FDA has signed off 4D pharma plc's (NASDAQ:LBPS) investigational new drug (IND) applications for two Live Biotherapeutics (LBPs), MRx0005 and MRx0029, for 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.
- "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.
- Also See: 4D Pharma's Asthma Candidate Shows Positive Trends In Multiple Secondary Endpoints Of Efficacy.
- MRx0005 and MRx0029 are two single-strain Live Biotherapeutic candidates, which have been shown pre-clinically to positively impact multiple key aspects of Parkinson's disease pathology.
- 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.
- The 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.
- Price Action: LBPS shares are down 9.89% at $3.28 during the market session on the last check Tuesday.
