- Clinical Investigator, Dr. Diana Kerwin, Presents Safety, Tolerability and PK Data at CTAD 2016 in Late-Breaking Oral Session
- Results Demonstrate that ABBV-8E12 is Safe and Well Tolerated at Doses up to 50 mg/kg in Subjects with Progressive Supranuclear Palsy
- Results are Guiding the Design of Phase 2 Studies in Subjects with Alzheimer’s Disease and Progressive Supranuclear Palsy
December 09, 2016
ST. LOUIS, MO – C2N Diagnostics today reported results from its Phase 1 study testing ABBV-8E12 (Formerly C2N-8E12) in patients with progressive supranuclear palsy (PSP). ABBV-8E12 is a humanized anti-tau monoclonal antibody currently under clinical investigation for the treatment of Alzheimer’s Disease and PSP, both progressive brain diseases currently lacking effective treatment options. Results from the first-in-human study were reported this morning as part of a Late-Breaking Oral Session at the Clinical Trials in Alzheimer’s Disease (CTAD) 2016 conference in San Diego, CA.
Dr. Diana Kerwin, a key investigator to the study and Chief of Geriatrics as well as Director, Texas Alzheimer’s and Memory Disorders at the Texas Health Presbyterian Hospital, presented the results. The presentation was entitled: “Safety, Tolerability and Pharmacokinetics of ABBV-8E12: A Humanized Anti-tau Monoclonal Antibody, in a Phase 1, Single Ascending Dose, Placebo-controlled Study in Subjects with Progressive Supranuclear Palsy.”
The study enrolled 30 subjects with PSP across 12 clinical sites throughout the United States. Patients were randomly assigned in a double-blinded manner to receive a one-time dose of either placebo or ABBV-8E12 at escalating doses up to 50 mg/kg. Subjects were followed out to 84 days post-dosing for safety, tolerability, and allergic reactions, as well as metabolism of the drug from the bloodstream.
Study participants were, on average, 69 years of age, with 53% being males. Demographic characteristics of the patients were well balanced across the different dose groups. ABBV-8E12 was safe and well tolerated when administered intravenously in single doses of up to 50 mg/kg. No dose-limiting toxicities occurred, and adverse event frequency and severity did not vary by dose or when compared to placebo. Further, no allergic reactions occurred in any of the study participants. Metabolism and brain penetration levels of the drug were also consistent with what has previously been observed for other monoclonal antibodies.
“We are extremely thankful to the patients and their family members who committed their time and energy to this study,” stated Dr. Joel Braunstein, CEO of C2N Diagnostics. “The burden to patients in any Phase 1 trial is high, but the information we have gathered from this study is vitally important. This was one of the first human clinical studies to test the safety of tau passive immunotherapy in individuals with PSP. We can now use these results to design longer-term studies that will assess the therapeutic potential of ABBV-8E12 in clinical indications where misfolded tau appears to play an essential role in disease progression.”
C2N established a global therapeutic partnership with AbbVie, Inc during 2015. With AbbVie’s leadership, the companies will soon launch Phase 2 clinical testing of ABBV-8E12 in both Alzheimer’s Disease and PSP.
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 firstname.lastname@example.org or call 1-877-C2N-DIAG (1-877-226-3424).