Oral treatment for Parkinson’s shows positive phase 2 results

Sage Therapeutics Inc. announced positive results from a phase 2 trial for an oral treatment that was linked to improvements in functioning, learning and memory in those with mild cognitive impairment from Parkinson’s disease.

Data on the first-in-class, positive allosteric modulator of the NMDA receptor, dubbed SAGE-718, were reported from the open label phase 2 PARADIGM study, part of the biopharmaceutical company’s early-stage trial platform to treat cognitive deficits across a range of brain disorders.

“Improving cognitive function is an area of significant unmet need in the management of Parkinson’s disease, as it is estimated that up to 50% of people living with PD are affected by cognitive changes, including mild cognitive impairment (MCI), that can result in loss of independence for patients,” Jim Doherty, PhD, chief development officer at Sage Therapeutics, said in a press release.

“We are encouraged by these preliminary data as they support our belief in the potential of SAGE-718 for the treatment of MCI in patients with PD, and we look forward to learning more from our multiple, ongoing or planned placebo-controlled clinical trials in patients with PD and other brain health disorders.”

Eleven participants in the PARADIGM study, aged 50 to 75 years with a diagnosis of idiopathic PD and MCI per the 2015 Movement Disorder Society criteria, received 3 mg of SAGE-718 daily and underwent multiple tests in order to assess cognitive performance, including the Digital Symbol Substitution Test, spatial working memory, stockings of Cambridge, the 2-Back Test and the Multitasking Test.

Positive results were seen in participants at day 14, and sustained effects and improving trends were reported at day 28. No serious adverse events were reported among participants, and SAGE-718 was generally well tolerated.