December 7, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Tomorrow—Thursday—is likely to be a big news day for Biogen , whether positive or negative. The Cambridge, Mass.-based company will be presenting data from an early-stage clinical trial of its Alzheimer’s drug, aducanumab, at the Clinical Trials for Alzheimer’s Disease (CTAD) annual conference held in San Diego.
Although investors and industry analysts, as well as anyone waiting for positive news about an Alzheimer’s treatment, are hopeful, experience has shown that when it comes to Alzheimer’s drugs, failure is the most common result. Most will remember all too well the November 23 failure of Eli Lilly and Company ’s EXPEDITION3 Phase III clinical trial of its own Alzheimer’s drug, solanezumab. And that drug has a number of similarities to Biogen’s aducanumab.
The two drugs are so closely linked that Biogen’s shares dropped about nine percent in pre-market trading the day Eli Lilly announced sola’s failure. However, there are enough differences to give observers hope. Both focus on beta-amyloid deposits in the brain. Both are monoclonal antibodies, but they have different targets and the two companies are analyzing different patient populations, with Biogen focused on patients with milder forms of Alzheimer’s and higher doses of the drug.
And earlier in the year, Biogen released early results of the trial that were very positive. “It’s really exciting data that they’ve presented so far,” said James Hendrix, director of global science initiatives at the Alzheimer’s Association to the Boston Business Journal. “It shows a path forward for the amyloid approach.”
The data being presented tomorrow is from that study, a Phase Ib trial, which is called a “titration arm.” In that study, the patients’ physician can adjust the drug’s dosage over time to fine-tune the patient response. Biogen is also conducting Phase III clinical trials with hopes of accelerating time to approval. But results from those trials aren’t expected until 2020.
Lilly will also be presenting additional data on its solanezumab at the conference. Analysts and scientists are interested in this, because it will provide more information about the amyloid hypothesis. That is to say, if Lilly’s data shows its drug significantly cut amyloid plaques in the patients’ brains, but there weren’t any cognitive improvements, it would cast doubt on the veracity of the amyloid theory. Of course, it’s possible that clearing beta-amyloid after it’s done damage to the brain won’t improve cognition, but may slow progress of the disease.
Shortly after Lilly’s announcement on November 23, analysts at Leerink Partners wrote in a research note, “We believe investors will not completely discount the value of aducanumab, at least after the CTAD presentations and discussions. For our own part, we will evaluate our model and probability of success and consider whether we should adjust our valuation as well.”
Although investors and Biogen undoubtedly have a financial interest in a positive result, so do anyone who has a family member or loved one or family history of Alzheimer’s disease. The Pharmaceutical Research and Manufacturers of America say there are 77 experimental compounds being developed for Alzheimer’s this year. It’s an area of unmet need and analysts have predicted that if aducanumab were to be approved, it could exceed $20 billion in annual sales. Almost any company would be happy to have even a modestly successful Alzheimer’s drug in its portfolio.
Biogen is currently trading at $291.16.
