C₂N Diagnostics Completes Phase 1 Clinical Study of C2N-8E12 (ABBV-8E12) Among Individuals with Progressive Supranuclear Palsy
Achievement Represents the Final Milestone Under C2N’s “Part the Cloud” 2015 Translational Research Award from Alzheimer’s Association
Paves Way for Future, Longer-Term Clinical Studies Involving ABBV-8E12 Through Partnership with AbbVie
October 13, 2016
ST. LOUIS, MO – C2N Diagnostics today announced that it has successfully completed the final follow-up visit of the last subject enrolled into its Phase 1, randomized controlled clinical study testing C2N-8E12 (ABBV-8E12), an anti-tau antibody, in patients with progressive supranuclear palsy (PSP). The milestone marks the last of multiple achievements under C2N’s Part the Cloud (PTC) Translational Research Award, granted to C2N by the Alzheimer’s Association in 2015. Also, this is an important program milestone under C2N’s global partnership with AbbVie, paving the way for future longer-term clinical studies involving ABBV-8E12 in neurodegenerative disorders characterized by tau pathology.
The Alzheimer’s Association’s PTC Award to C2N provided funding that supported and accelerated the launch of one of the first controlled, human clinical safety trials of an anti-tau antibody therapy in individuals with PSP (NCT02494024).
“We deeply appreciate the support we have received from Alzheimer’s Association over the last year,” stated Joel Braunstein, M.D., Chief Executive Officer, C2N. “With completion of this milestone, we are pleased to help the Alzheimer’s Association move one step closer to its goal under its Part the Cloud program; that is, to advance research on potential drug therapies that have the highest probability of slowing or stopping Alzheimer’s disease and other dementias, which currently affect more than 47 million people worldwide. From this milestone, C2N can now analyze the phase 1 data and share the study’s findings with clinicians and the patient community at a medical meeting in the future.”
The phase 1 study enrolled 30 subjects with PSP across 12 clinical sites throughout the United States. It randomly assigned individuals to receive a one-time dose of either placebo or ABBV-8E12 at escalating doses. Subjects were followed for safety, tolerability, and allergic reactions, as well as metabolism of the drug from the bloodstream.
Stated Tim West, Ph.D., C2N’s Vice President of Research & Development, “Tau is a protein involved in the pathological progression of PSP, Alzheimer’s disease, and many other serious neurodegenerative diseases. Pre-clinical studies have shown that C2N’s anti-tau antibody can slow the progression of tau pathology. We look forward to working with our partner, AbbVie, to continue testing ABBV-8E12 in future clinical studies to understand the therapeutic potential of this novel strategy to fighting disease.”
About C2N Diagnostics
C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a technology research and venture development firm (www.lifetechresearch.com). In March 2015, C2N formed a global partnership with AbbVie to develop and commercialize a portfolio of anti-tau antibodies (including ABBV-8E12) for the treatment of Alzheimer’s Disease and other neurological disorders. In July 2015, C2N and AbbVie announced FDA Orphan Drug Designation of ABBV-8E12 for the treatment of PSP. Beside its therapeutic development efforts, C2N is commercializing a suite of biomarker tests to enable drug discovery, clinical drug development at lower risk and cost, and early detection of debilitating neurodegenerative disorders before symptom onset. The company's products include the SILK-Aβ®, SILK-ApoE™, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and quantitation of brain derived proteins. Beyond Alzheimer's Disease, products are in development to target Parkinson's Disease, traumatic brain injury, schizophrenia and Amyotrophic Lateral Sclerosis, among other conditions. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).