4D pharma PLC (AIM:DDDD, NASDAQ:LBPS) received the green light for a first-in-human trial of its Parkinson’s disease candidates in the US.
This is after the Food & Drug Administration approved investigational new drug (IND) applications for MRx0005 and MRx0029.
4D said expects to get its phase I study underway in the middle of the year.
Both prospective treatments are what the company describes as live biotherapeutic products (LBP), meaning they are derived from the human microbiome, the bacterial ecosystem that resides mainly in the gut.
"We believe MRx0005 and MRx0029 are the first-ever live biotherapeutic products for Parkinson's to enter the clinic," said Dr Alex Stevenson, 4D’s chief scientific officer.
He noted that current treatments focus on symptoms but do not address the underlying causes of neurodegeneration.
“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,” Stevenson added.
“We believe that our LBPs 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."