At FitnessHealth101, we often report on studies that show promise for experimental medications. Unfortunately for some of these drugs, additional trials often show that they weren’t as safe or effective as the initial studies suggested. This particular scenario just occurred with an experimental Alzheimer’s drug undergoing studies by Johnson & Johnson and Pfizer Inc. The two companies have now scrapped their research plans for this drug, called bapineuzumab, which was initially deemed useful for individuals with mild or moderate Alzheimer’s.
Although the drug may be studied later in various forms, Pfizer and Johnson & Johnson have decided to cancel two pending studies, including two additional late-stage Bapineuzumab clinical trials as well as follow-up studies, that would’ve examined the drug in its intravenous form.
The End of Bapineuzumab
The announcement from the two pharmaceutical companies comes on the heels of another late-stage study cancellation that occurred just a few weeks ago. In the case of bapineuzumab, researchers were confident that the drug would be deemed a success if it passed the second trial. The news is particularly disappointing because bapineuzumab was on track to be the first drug approved for fighting the progression of Alzheimer’s.
Now that bapineuzumab is off the table, researchers will now focus their attention on solanezumab, another experimental drug with a similar purpose. Solanezumab, currently in development by pharmaceutical firm Eli Lilly & Co, is also being given a small chance of success, though we won’t know for sure until more study results come available later in 2012.
The specific problem with bapineuzumab, uncovered by the most recent trial, is that it fails to improve functional or cognitive performance in Alzheimer’s patients who lack a specific variation of the ApoE4 gene. The drug was already found to be unsuccessful in patients who do have this gene variation, but researchers hoped that the more recent study would prove its effectiveness for those lacking the genetic variation. It did not.
Steven Romano, chief of the Medicines Development Group within Pfizer, Inc, described the outcome of the trial as “very disappointing” and said he was “saddened by the lost opportunity” to make major strides in the battle against Alzheimer’s.
Early Treatment of Alzheimer’s is Extremely Important
Although the intravenous form of bapineuzumab will no longer be studied, both Pfizer and Johnson & Johnson plan to conduct additional studies of the subcutaneous version of bapineuzumab. So far, these studies are slated to not include patients with the earliest forms of the disease, or those who display no symptoms.
However, Alzheimer’s researchers generally maintain that any successful treatment will be one used when the disease is in its earliest form, or even before it develops in those who are already at a high risk for Alzheimer’s. Many researchers expected bapineuzumab to fail simply because it was designed to treat patients who already had advanced cases of the disease.
A Total Loss?
Alzheimer’s Association chief scientific officer William Thies said that the trials still provide important information to Alzheimer’s researchers even if the drug being studied has been deemed a failure: “These studies are terribly important for us to learn about Alzheimer’s disease, and that part of the process is just starting as the data continues to be crunched in a variety of ways.”
Thies also said that bapineuzumab could still potentially be used in prevention trials, or studies that look to examine the effects of drugs on diseases before those diseases actually develop. Just because a drug failed on those with mild to moderate Alzheimer’s does not necessarily mean it will fail in preventing the disease for high-risk individuals, according to Thies. Thies said that one such prevention trial, conducted by the Dominantly Inherited Alzheimer’s Network, will be finalized before the end of the year.
Bapineuzumab Clinical Trials: The Bottom Line
Research regarding an Alzheimer’s drug called bapineuzumab has been discontinued due to a recent study finding the drug ineffective. Alzheimer’s disease affects 36 million people around the world, and over 5 million Americans. It is the sixth-largest cause of death in the U.S.
The full text of the news release can be read at Pfizer’s website.