Sage Therapeutics Announces Presentation of Encouraging Results from the Phase 2 PARADIGM Study (Part A) of SAGE-718 in Patients with Mild Cognitive Impairment due to Parkinson’s Disease
Data Presented at the AD/PD 2022 Advances in
The PARADIGM Study is a Phase 2, open-label study evaluating the safety, tolerability, and efficacy of SAGE-718 once daily in individuals with mild cognitive impairment due to Parkinson’s disease
Patients who received SAGE-718 in the study experienced improvement in performance of cognitive tests of executive functioning and learning and memory
“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
In 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
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.
About the PARADIGM Study (Part A)
The PARADIGM Study (Part A) was a Phase 2, open-label study with a primary objective to evaluate the safety, tolerability, and efficacy of SAGE-718 in patients with MCI due to PD. During the 2-week screening period, patients were assessed for the prespecified inclusion and exclusion criteria. Eligible patients were aged 50 to 75 years, had a diagnosis of idiopathic PD and MCI per the 2015
SAGE-718, Sage’s first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including Huntington’s disease (HD), Parkinson’s disease (PD) and Alzheimer’s disease (AD). Ongoing and planned studies aim to evaluate whether SAGE-718 may have the potential to improve cognitive symptoms for these difficult-to-treat disorders. SAGE-718 is currently being studied in the ongoing Phase 2 DIMENSION Study, a double-blind placebo-controlled study in people with early to moderate HD cognitive impairment that is designed to evaluate the efficacy of once-daily dosed SAGE-718 over three months. Sage expects to initiate additional Phase 2 studies evaluating SAGE-718 in HD, PD and AD in 2022. In 2021, SAGE-718 received Fast Track Designation from the FDA for development of SAGE-718 as a potential treatment for HD.
Various statements in this release concern future expectations, plans and prospects, including without limitation statements regarding: Sage’s belief in the potential profile and benefit of SAGE-718 and the potential impact of the findings from the PARADIGM Study; our goals and plans for further development of SAGE-718 and the potential for successful development; our estimates as to the number of patients with Parkinson’s Disease who are affected by cognitive changes; our belief in the need for new treatment options for this indication; the goals, opportunity and potential for the SAGE-718 program; and the mission and goals for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the positive results from the PARADIGM Study may not be repeated in future studies in Parkinson’s Disease cognitive impairment or in other indications we are studying or may study in the future with SAGE-718, and future clinical results may not meet their primary or key secondary endpoints; clinical and nonclinical data we generate in the course of our development program may not be sufficient to file for or gain regulatory approval to market SAGE-718 without further development work or may not support further development at all; we may encounter adverse results or adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may encounter delays in initiation, conduct or completion of ongoing or future clinical trials that may impact our ability to meet our expected time-lines; the FDA may not agree with our view of the data we generate from our development efforts at any stage; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, or progress of ongoing or future clinical trials and our ability to proceed with further development; the FDA may ultimately decide that the design or results of completed and planned clinical trials, even if positive, are not sufficient for regulatory approval of SAGE-718 in any indication or of any of our other product candidates in any indications that are the focus of our development programs and plans; the actual size of the patient population in Parkinson’s Disease cognitive impairment or in any other indication we study and the unmet need for new treatment options may be significantly lower than our estimates and, even if SAGE-718 is approved for any indication, it may only be approved or used to treat a subset of the relevant patient population; we may encounter technical and other unexpected hurdles in the development and manufacture of SAGE-718 or our other product candidates which may delay our timing or change our plans; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Annual Report on Form 10-K, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the