FDA grants IND for phase 1 study of biotherapeutic Parkinson’s treatment

The FDA has granted an investigational new drug application to 4D pharma plc for two live biotherapeutics to treat Parkinson’s disease, according to a company release.

The pharmaceutical company plans to initiate a multicenter, randomized, double-blind, placebo-controlled phase 1 clinical trial in mid-2022 to evaluate the products, MRx0005 and MRx0029, in patients with PD.

“Entering the clinic with our novel [central nervous system] programs stemming from our proprietary MicroRx platform will represent an important step for 4D pharma’s continued growth and leadership in the microbiome field,” Alex Stevenson, chief scientific officer of 4D pharma, said in the release.

MRx0005 and MRx0029 are oral, single-strain live biotherapeutics that have been developed to treat PD symptoms via the gut-brain axis. According to the release, both products have been shown pre-clinically to reduce neuroinflammation induced by alpha-synuclein and to protect neurons from oxidative stress-induced death.

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