4D Pharma gets FDA clearance for potential Parkinson’s treatments

Biotherapeutic pharmaceutical company 4D Pharma announced on Tuesday that the United States Food and Drug Administration (FDA) has cleared investigational new drug applications for ‘MRx0005’ and ‘MRx0029’, for the treatment of Parkinson’s disease.

The AIM-traded firm said it expected to initiate a first-in-human phase 1 clinical trial in people with Parkinson’s disease in mid-2022.

It described MRx0005 and MRx0029 as two unique, single-strain live biotherapeutic candidates, which had 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 said it expected to initiate a phase 1 clinical trial in mid-2022, with the multi-centre, randomised, double-blind, placebo-controlled study set to evaluate the safety and tolerability of MRx0005 or MRx0029 in separate cohorts of patients with Parkinson’s disease.

In addition to safety, the study would measure biomarkers relating to the mechanisms of action of the candidate live biotherapeutics.

“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,” said chief scientific officer Dr Alex Stevenson.

“We believe MRx0005 and MRx0029 are the first ever live biotherapeutic products for Parkinson’s to enter the clinic.

“Current treatments focus on symptoms but do not address the underlying causes of neurodegeneration.”

Dr Stevenson said patients and clinicians were in need of new, more effective treatment options, describing the gut-brain axis as an “exciting area of innovation”, with the potential to change the way Parkinson’s treatment was approached.

“We believe that our live biotherapeutics 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.”

At 1400 GMT, shares in 4D Pharma were up 1.21% at 30.87p.