PITTSBURGH, October 2, 2018 — Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on synaptic health and restoration in Alzheimer’s disease and other neurodegenerative disorders, today announced that the National Institute on Aging (NIA) of the National Institutes of Health (NIH) has awarded the Company a multiyear grant expected to total $16.6 million to support the Phase 2 SHINE study of Elayta™ (CT1812).
SHINE (Synaptic Health and Improvement of Neurological Function with Elayta) is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study expected to enroll up to 160 adults with mild-to-moderate Alzheimer’s disease (MMSE 18-26). Cognition expects to initiate patient dosing in the SHINE study during the fourth quarter of 2018. SHINE will be conducted in two parts. Part A will enroll 24 adults who will receive Elayta at doses of 100 or 300 mg per day or placebo for 6 months. Part B will be initiated pending the successful completion of Part A and will randomize up to 134 additional individuals into the study with the same design and duration.
“NIA’s continued commitment to helping Cognition advance this novel compound is a testament to the potential we all see for Elayta to make a meaningful difference in the lives of people suffering from Alzheimer’s disease,” said Chief Science Officer Susan Catalano, Ph.D. “We are truly honored by the support of the NIA and the confidence that our peers have shown in the science underpinning Elayta.”
Elayta is currently in Phase 2 clinical development for the treatment of mild-to-moderate Alzheimer’s disease. Cognition recently initiated patient dosing/treatment in the SNAP and SPARC studies, which are designed to provide additional insights into Elayta’s mechanism of action and are both also supported by NIA grants. SNAP (Aβ Oligomer Displacement from Synapses on Neurons in Alzheimer’s Patients) is a target engagement study designed to measure the displacement and clearance of the neurotoxic species of the Aβ protein, Aβ oligomers, after a single dose of Elayta. SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition) is designed to measure changes in synapse density over the course of 6 months of therapy with Elayta, as a means of determining the extent to which synapses are restored after displacement of toxic Aβ oligomers and their clearance from the brain.
“NIA support has been critical to our efforts to demonstrate that Elayta not only protects synapses but also enables the reversal of synaptic damage and loss – what we refer to as “synaptic restoration,” said President and CEO Kenneth I. Moch. “If Elayta continues to demonstrate the potentially disease-modifying synaptorestorative effect we’ve observed to date – essentially to “turn the lights back on” for individuals with Alzheimer’s disease – this would be a major advance in altering the devastating progression of Alzheimer’s disease.”
SHINE is supported by the NIA under award number R01AG058660. More information about SHINE may be found at www.clinicaltrials.gov under trial identifier NCT03507790.
About Elayta (CT1812)
Cognition’s lead product candidate, Elayta (CT1812), a highly brain penetrant small molecule with a unique disease-modifying synaptorestorative mechanism of action, is currently in Phase 2 clinical testing for mild-to-moderate Alzheimer’s disease. This orally dosed drug candidate, which was discovered by Cognition’s scientific team led by Susan Catalano, Ph.D., facilitates the restoration and protection of synaptic function by selectively displacing toxic beta amyloid oligomers (AβOs) from their synaptic receptors, thus stopping downstream damage and improving memory function. Consistent with these findings, Cognition’s Phase 1b/2a clinical trial (COG0102) demonstrated that Elayta significantly reduces concentrations of synapse damage proteins in the cerebrospinal fluid of Alzheimer’s patients. Elayta has been granted Fast Track designation by the U.S. FDA.
Patient dosing recently commenced in two clinical studies of Elayta: SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition) and SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients). SNAP and SPARC are funded by grants from the National Institute on Aging of the National Institute of Health (award numbers RF1AG057780 and RF1AG057553.)
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a privately held biopharmaceutical company focused on synaptic health and restoration in neurodegenerative disorders through a pipeline of disease modifying small molecule drug candidates. Cognition’s lead candidate, Elayta, is a proprietary first-in-class, orally available small molecule that has shown synaptorestorative potential and is in development for the treatment of mild-to-moderate Alzheimer’s disease. Elayta and Cognition’s other pipeline candidates were identified using the company’s disease-relevant screening and novel chemistry platforms. Additional information about Cognition and its product candidates may be found online at https://cogrx.com.
This press release contains “forward-looking statements.” Forward-looking statements contained in this press release include, without limitation, statements regarding Cognition’s expectations regarding the clinical development of Elayta for the treatment of mild-to-moderate Alzheimer’s disease, the potential clinical benefits of Elayta for patients who have been diagnosed with Alzheimer’s disease, the expected enrollment and clinical trial timelines of Cognition’s SHINE, SPARC and SNAP trials, the expected results of Cognition’s SHINE, SPARC and SNAP trials and whether the results of Cognition’s preclinical studies and early clinical trials will be indicative of the results of the SHINE, SPARC and SNAP trials. In addition, words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks, assumptions, uncertainties and other factors that are outside of Cognition’s control. All forward-looking statements are based on Cognition’s expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Cognition undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.