Oral treatment may improve symptoms of Parkinson's, show positive phase 2 results

CAMBRIDGE: An oral treatment has been linked to improvements in functioning, learning and memory in those with mild cognitive impairment from Parkinson's disease, according to Positive results from a phase 2 trial announced by Ms Sage Therapeutics Inc.

The presentation of data has shown that SAGE-718, a first-in-class, oral, positive allosteric modulator of the NMDA receptor, was associated with improvements on multiple tests of executive functioning and learning and memory in patients with mild cognitive impairment (MCI) due to Parkinson's disease (PD) in the open label Phase 2 PARADIGM Study.

The PARADIGM Study (Part A) is part of CogNEXT, Sage's early-stage trial platform designed to evaluate the therapeutic potential of SAGE-718 to treat cognitive deficits across a range of brain health disorders. The data were presented as a virtual oral presentation at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders taking place from March 15-20 both in-person in Barcelona, Spain, and virtually.

"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 percent of people living with PD are affected by cognitive changes, including mild cognitive impairment, that can result in loss of independence for patients," said Jim Doherty, Ph.D., Chief Development Officer at Sage.

"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 disordersIn the PARADIGM Study (Part A), a comprehensive battery of tests was used to assess multiple domains of cognitive performance in eleven patients receiving SAGE-718 3 mg once daily.

Tests included the Digital Symbol Substitution Test, spatial working memory, stockings of Cambridge, the 2-Back Test and the Multitasking Test. SAGE-718 was associated with improved performance at Day 14, compared to baseline, on tests of executive functioning, and an emerging signal suggests improved performance on tests of learning and memory (paired associates, pattern recognition, and verbal memory).

Sustained effects and improving trends were seen out to Day 28 for assessments completed at the follow-up visit. As expected, no appreciable effect was observed on measures of simple attention/psychomotor speed, in keeping with the profile of SAGE-718 based on data to date. These data support the further development of SAGE-718 in PD-MCI, suggesting improved performance on executive functioning, as well as promising signals on learning and memory.

SAGE-718 was generally well tolerated in the PARADIGM Study (Part A); there were no serious adverse events and no treatment emergent adverse events were determined to be related to SAGE-718.."