Alzheimer’s drug tests failure

There is often a fanfare about the promising affects of prospective new drugs. Most fail in testing and are quietly put rest without widespread announcements. Bapineuzumab failed in human tests.


LONDON, UK (GlobalData), 9 August 2012 - Globally there are an estimated 36 million people who suffer from dementia including the neurodegenerative disease Alzheimer’s, a number that is projected to double every 20 years.


There is clearly a need for more effective therapies that address this and other neurodegenerative diseases; however, the R&D efforts put forth by pharmaceutical companies have rarely been successful, as illustrated by the recent failure of the Alzheimer’s drug bapineuzumab in clinical trials.


Johnson & Johnson and Pfizer in separate press releases on August 6, 2012 announced the discontinuation of their joint Phase III clinical development of intravenous (IV) bapineuzumab in mild-to-moderate cases of Alzheimer’s disease.


This comes on the heels of disappointing results from the clinical trial Study 301, in which bapineuzumab was being tested in patients who are non-carriers of the ApoE4 (Apolipoprotein E epsilon 4) gene.


Results indicated that bapineuzumab did not satisfy either cognitive or functional performance endpoints. These disappointing study results follow similar results announced on July 23 from Study 302, in which bapineuzumab also failed to meet clinical endpoints in ApoE4 carrier patients.


Bapineuzumab IV is an antibody that targets the beta-amyloid protein (A beta), which is believed to cause brain toxicity and is implicated in the pathology of Alzheimer’s disease.


This immunotherapy approach is novel and is part of efforts to provide therapies that target the progression of Alzheimer’s disease as compared with existing therapies that are only palliative.


Eli Lilly is also developing a similar drug, solanezumab, which is currently in Phase III clinical trials with results expected later this summer. Many scientists believe that for any therapy to be successful in impacting Alzheimer’s progression, it has to be started early, before damage to the brain has set in. Therefore, both bapineuzumab and solanezumab were already considered long-shots by many scientists and researchers because of the late stage of disease in the trials.


However, limitations in diagnostic tools for Alzheimer’s make it difficult to make early diagnoses, and the search for biomarkers that will aid in this effort is an active area of research.


Many pharmaceutical companies already consider R&D in the neurosciences a highly risky proposition given the required capital investment. Results such as these for bapineuzumab will no doubt further this sentiment at a time when several major pharmaceutical companies have already strategically been pulling away from the neurosciences. Pfizer, GSK, AstraZeneca and Merck have all restructured or downsized their neuroscience research efforts, while Novartis recently shut down its neuroscience research facility in Basel, Switzerland. Pharmaceutical companies have opted to redirect their resources towards oncology where endpoints are clearer and drug approval is less difficult.


Neuroscience meanwhile remains one of the least understood areas of biology, and neurological disorders are considered by the World Health Organization (WHO) as one of the greatest threats to public health. It seems counterintuitive that given the global impact of neurological diseases, and the dearth of existing knowledge in the neurosciences, both academic and industry research in this field would be under threat. While one can acknowledge the challenges that neuroscience research presents, in an era of technological advancement, it doesn’t bode well for humanity that we would seemingly be walking away from a challenge that impacts the health of millions across the globe.


See the full article written by Neurology Analyst, Dr. Sally Chegeat, Alzheimer’s Drug (Bapineuzumab) Failure: Implications for Future R&D in Neuroscience.


9 August 2012.