FDA Approves Initiation of Phase 2 Trial of Sodium Oligomannate for Parkinson Disease Treatment

The Food and Drug Administration (FDA) gave the green light for the phase 2 clinical trial of sodium oligomannate (GV-971; Green Valley Pharmaceuticals, Shanghai) for early-stage Parkinson disease (PD). 

When studying the effects of sodium oligomannate on PD in preclinical research, there was a reduction in neuroinflammation, protection of dopaminergic neurons, and improvement in motor and nonmotor symptoms.

The phase 2 clinical trial will enroll 300 participants with early-stage PD. Participants will be treated with sodium oligomannate or placebo for 36-week followed by an open-label extension period.

Sodium oligomannate is originally intended to treat Alzheimer Disease(AD) and targets the gut-brain axis, reducing peripheral and central inflammation1 by reconditioning the gut microbiota and inhibiting the abnormal balance of gut microbiota-derived metabolites.

The phase 3 trial for sodium oligomannate in AD was conducted in 34 tier-1 hospitals across China with 818 participants with mild-to-moderate AD. Results of the trial demonstrated sodium oligomannate significantly improved cognitive function and was safe with side effects comparable to placebo.

In April 2020, the application for the global multi-center phase 3 clinical trial of sodium oligomannate was approved by the FDA. Currently, 154 clinical centers have been activated, with 949 participants screened and 292 participants randomized. The trial is scheduled for completion by 2025.