PITTSBURGH, Nov 8, 2018 — Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on synaptic protection and restoration in Alzheimer’s disease and other neurodegenerative disorders, today announced that patient treatment has begun in the Phase 2 SHINE study of Elayta™ (CT1812), Cognition’s lead candidate for the treatment of mild-to-moderate Alzheimer’s disease. SHINE (Synaptic Health and Improvement of Neurological Function with Elayta) is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 efficacy and safety study designed to enroll up to 160 adults with mild-to-moderate Alzheimer’s disease (MMSE 18-26).
The SHINE study (COG0201) will be conducted in two parts. Part A will enroll 24 adults who will receive Elayta in oral 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, doses and study duration. The study is funded by a previously announced grant expected to total $16.6 million from the National Institute on Aging of the NIH under award number R01AG058660.
Steven T. DeKosky, M.D., the Aerts-Cosper Professor of Alzheimer’s Research at the University of Florida College of Medicine and chair of Cognition’s Medical Advisory Board, stated, “Unlike therapies such as BACE inhibitors that target beta amyloid (Aβ) monomers, Elayta’s mechanism of action is unique in that it has shown the potential to protect synapses from the deleterious effects of Aβ oligomers and facilitate the restoration of synapse number and cognitive performance to normal. The SHINE study, if successful, has the potential to restore the Alzheimer’s community’s optimism for disease-modifying therapies and give hope that people currently experiencing Alzheimer’s symptoms could have meaningful stabilization or improvement of cognition.”
“The SHINE study is the culmination of substantial preclinical and clinical work characterizing Elayta and its unique synaptorestorative mechanism of action,” added Cognition Chief Science Officer Susan Catalano, Ph.D. “Our clinical development program has been carefully designed to provide efficacy and safety evidence as well as important insights into the pathology of Alzheimer’s disease and biomarkers of disease progress. We look forward to sharing our findings so that the entire Alzheimer’s community may benefit from our evolving understanding of this complex disease.”
In addition to the SHINE study, Elayta is currently being assessed in the SNAP (Aβ Oligomer Displacement from Synapses on Neurons in Alzheimer’s Patients) study, which is measuring the displacement and clearance of Aβ oligomers after a single dose of Elayta, and the SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition) study, which is measuring changes in synapse density as assessed by synaptic markers in positron emission tomography (PET) over the course of 6 months of therapy with Elayta.
Cognition President and CEO Kenneth I. Moch concluded, “We have made significant progress this year, having achieved our planned clinical development milestones for Elayta including the initiation of three clinical studies: SNAP, SPARC and now SHINE. The data generated by these studies will demonstrate if and to what extent we are able to ‘turn the lights back on’ by facilitating the protection or regeneration of synapses and slowing or reversing cognitive decline in symptomatic Alzheimer’s patients.”
More information about SHINE is available at http://www.clinicaltrials.gov under 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 protection and restoration 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 (CSF) of Alzheimer’s patients. Elayta has been granted Fast Track designation by the U.S. FDA.
Patient dosing has commenced in three clinical studies of Elayta: SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition), SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients) and SHINE (Synaptic Health and Improvement of Neurological Function with Elayta). Each of these studies are funded by grants from the National Institute on Aging of the National Institute of Health (award numbers RF1AG057780, RF1AG057553 and R01AG058660).
These studies, as well as other work by Cognition and members of the scientific community, will help to further elucidate the mechanism by which Elayta displaces toxic AβOs from their synaptic receptors, facilitating AβO clearance from the brain into the CSF and enabling the protection and restoration of synaptic function. During the recent Society for Neuroscience Annual Meeting in San Diego, Cognition sponsored The Third International Symposium on Sigma-2 Receptors: Role in Health and Disease at which experts described and discussed new research findings pertaining to the structure and function of these multi-protein receptor complexes. All of the presentations from the Symposium may be viewed on the Cognition website under Our Events.
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a privately held biopharmaceutical company focused on synaptic protection 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.wpengine.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.