Michael Harper for redOrbit.com – Your Universe Online
After another failed high-profile clinical trial, pharmaceutical companies Pfiizer Inc and Johnson & Johnson have said they´ve halted research and development of bapineuzumab, a drug which could have been used in patients with mild to moderate Alzheimer’s disease.
According to Reuters, both drug makers have said they´ll discontinue their studies of bapineuzumab in its intravenous (IV) form. Two late stage trials and follow-up studies which had already been planned will also be scrapped as a result of this announcement.
This is the second time in recent weeks the drug has been proven ineffective in treating patients with mild to moderate Alzheimer’s disease. What´s more, many had predicted bapineuzumab to have a better chance of success during the second trial, making the result and subsequent announcements particularly disappointing.
Should bapineuzumab had been successful, it would have been the first drug to ward off the effects of the brain disease which affects as many as 36 million people worldwide.
“We are obviously very disappointed in the outcomes of this trial. We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer’s disease and their caregivers,” said Steven Romano, senior vice president at Pfizer Inc, speaking to the Associated Press.
“Yet these data, and the subgroup and biomarker analyses under way, will further inform our understanding of this complex disease and advance research in this field.”
With development of bapineuzumab halted, the medical world now looks to solanezumab, a similar drug being developed by Eli Lilly & Co. Many are dubious about solanezumab´s chances to succeed, however, and are waiting to see how the drug performs in similar, late-stage tests.
Wall Street responded to this announcement, as shares of all three pharmaceutical companies, Pfizer, Johnson & Johnson and Lilly fell in after hours trading.
In these latest failed studies, bapineuzumab was unable to improve both cognitive or functional performance in patients who did not carry a variation of the ApoE4 gene when compared to a placebo treatment, according to the results released on Monday.
Pfizer, on the other hand, announced their failure in the first of four important trials on July 23rd. According to the Reuters report, many had considered the Pfizer tests to be a “long shot” based on the poor results of earlier trials.
Though the IV portion of bapineuzumab has been halted, both Johnson & Johnson and Pfizer have said they´ll continue a Phase II study of a version of the drug which can be applied subcutaneously. There are, however, no plans to test the drugs on patients who aren´t displaying any symptoms of Alzheimer’s or are in the early stages of the disease.
Scientists and researchers widely believe any treatment of the disease should begin early or even before a high-risk patient begins to notice the symptoms. As such, many of these researchers and scientists had expected the late-stage trials to fail, saying the companies were treating patients who had already suffered damage to their brains.
Despite these failures, William Thies, chief scientific officer of the Alzheimer´s Association told Reuters he was eager to see a full analysis of the results.
“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.”