After consultation with the FDA and EMA, AbbVie is beginning the Phase 2 clinical trial programs following completion of pre-clinical studies and a Phase 1 study in patients with PSP, which supported the further development of ABBV-8E12 in PSP and early Alzheimer's disease. Positive results from the Phase 1 study in PSP were recently released at the Clinical Trials on Alzheimer's Disease (CTAD) annual meeting in December 2016.3
The Phase 2 study in early Alzheimer's disease will enroll 400 patients to assess the efficacy and safety of ABBV-8E12 to delay disease progression (NCT02880956).4 The Phase 2 study in PSP will evaluate 180 adults and assess the efficacy and safety of ABBV-8E12 to slow disease progression (NCT02985879).5
According to the FDA, Fast Track Designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.6 In the U.S., the FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.7 In the EU, Orphan Designation is granted to therapies aimed at the treatment, prevention or diagnosis of life-threatening diseases that affect no more than five in 10,000 persons in the EU and for which no satisfactory therapy is available. The medicine must also provide significant benefit to those affected by the condition.8
ABBV-8E12, licensed from C2N Diagnostics in 2015, is a humanized antibody being studied to target the tau protein, which is thought to stabilize intracellular structures required for maintenance and transport in neurons. Abnormal accumulation of altered tau protein is a hallmark in a variety of neurodegenerative conditions, where the development of tau pathology strongly correlates with clinical disease progression.9
About Alzheimer's Disease
Alzheimer's disease is a progressive, neurodegenerative disorder affecting approximately 34 million people worldwide with the patient population expected to nearly triple by 2050.10 It is the sixth leading cause of death in the U.S. and there are currently no treatments to prevent or delay disease progression.11
About Progressive Supranuclear Palsy
Progressive supranuclear palsy (also known as Steele-Richardson-Olszewski syndrome) is a progressive neurodegenerative disorder, with an estimated worldwide annual incidence of three to six per 100,000 people; and within the U.S., the disease affects approximately 20,000 individuals.12 The average onset of PSP symptoms typically begins after age 60. The most common features of PSP are loss of balance leading to unexplained falls, blurred vision, problems controlling eye movement and slurred speech. Other nonspecific symptoms of PSP, such as slowed movements or behavioral or cognitive changes, are similar to other brain disorders, particularly Parkinson's disease. For this reason, correct diagnosis of PSP is often delayed. The course of PSP is progressive and may predispose individuals to serious complications, such as choking, pneumonia, head injury and fractures caused by falls. Currently, there are no approved treatments for PSP.12 It is one of more than 20 different neurodegenerative disorders characterized by neurofibrillary degeneration and tau inclusions as a predominant central nervous system lesion.9
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 U.S. Food & Drug Administration. Orphan Drug Designations and Approvals: recombinant humanized anti-tau antibody. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=460914. Accessed January 2017.
2 European Medicines Agency. Humanised recombinant IgG4 anti-human tau antibody for the treatment of progressive supranuclear palsy. http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2016/05/WC500207488.pdf. Accessed January 2017.
3 West T, et al. 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 [CTAD abstract OC33]. J Prev Alz Dis. 2016;3(1):285.
4 ClinicalTrials.gov (2017). NCT02880956. https://clinicaltrials.gov/ct2/show/NCT02880956?term=8e12&rank=2. Accessed January 2017.
5 ClinicalTrials.gov (2017). NCT02985879. https://clinicaltrials.gov/ct2/show/NCT02985879?term=8e12&rank=3. Accessed January 2017.
6 U.S. Food & Drug Administration. Fast Track. http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399. Accessed January 2017.
7 U.S. Food & Drug Administration. Developing Products for Rare Diseases & Conditions. http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525. Accessed January 2017.
8 European Medicines Agency. Orphan Designation. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp. Accessed January 2017.
9 Schraen-Maschke S. Tau as a biomarker of neurodegenerative diseases. Biomark Med. 2008 Aug; 2(4): 363–384.
10 Barnes D, et al. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep; 10(9): 819–828.
11 Alzheimer's Association. 2016 Alzheimer's Disease Facts and Figures. http://www.alz.org/documents_custom/2016-facts-and-figures.pdf. Accessed January 2017.
12 National Institute of Neurological Disorders and Strokes. Progressive Supranuclear Palsy Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Progressive-Supranuclear-Palsy-Fact-Sheet. Accessed January 2017.
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