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Biogen (BIIB) and its partner Eisai have announced the completion of their Phase III clinical trials on aducanumab following an independent analysis showing that the drug was unlikely to succeed. For some, the end of these trials was a shock. for others, we had to wait for it. The words of philosopher Karl Popper are perhaps a good epitaph for another unsuccessful Alzheimer's essay on amyloid:
Whenever a theory appears to you as the only possible one, take it as a sign that you have neither understood the theory nor the problem it was supposed to solve.
The failure of the anti-amyloid approach relies on two erroneous assumptions: firstly, amyloid oligomers are the only possible cause of Alzheimer's disease and secondly, genetic mutations leading to overproduction of 39, amyloid "prove" that amyloid is the only cause of the disease. disease (criticism of the amyloid hypothesis). The difference between a substance being the cause of an illness and a cause of a disease is enormous.
Biogen and Eisai have not completely abandoned the amyloid approach. One day after recognizing the failure of aducanumab, Eisai announced the continuation of the Phase III clinical trial of BAN2401, an anti-amyloid antibody. Several analysts however felt that aducanumab was the best candidate (analyst one, analyst two). In addition, Biogen may not be completely on board with the decision of Eisai (conjecture). The two companies are also testing a BACE-elenbecestat inhibitor drug, but this approach has also failed in the past.
Biogen is also in the anti-tau field, but it is a step forward rather than a step forward. The misfolded tau proteins can cause neurotoxicity through the binding of zinc and copper, but probably not more than by amyloid (neurotoxicity of metals). Nitrate tau interferes with neurotransmissions, but it is only one of many factors creating cognitive deficits in Alzheimer's disease.
Other companies continue to test for anti-amyloid antibodies, suggesting that they can treat the disease by more selectively targeting amyloid oligomers or starting well before the onset of the disease. Roche (OTCQX: RHHBY), for example, is currently testing its drug, crenezumab, in Colombian families with a gene mutation of presenilin-1, which still results in the early onset of the disease. Alzheimer. But the gene does not determine the age of onset. Thus, in Japan, two family members with exactly the same gene developed the disease almost ten years later than their Colombian counterparts (mean age of onset). Family members carrying the gene in Colombia are exposed to some of the highest mercury levels in the world due to mining activities, while in Japan their diet is rich in antioxidants, including the green tea and rice bran. Mercury increases the brain damage due to nitro-oxidation, caused by the mutation of the presenilin-1 gene, while drinking green tea and eating rice bran limit this damage. How many years will it take for amyloid disease to delay the onset of the disease in family members with the presenilin-1 gene mutation in Colombia? Would the reduction of mercury exposure or the introduction of an antioxidant diet delay even longer Colombian families than the elimination of amyloid? No answers to these questions at this stage. We "only know" that the elimination of amyloid temporarily delays the onset of the disease and only slightly slows its early progression.
Biogen's nearly 100-point decline in the announcement of devastating news about the aducanumab was in part the product of people who bought the company's public relations system. Although Biogen had never promised to cure Alzheimer's disease, she still suggested that she was about to make a big dent against Alzheimer's disease (Biogen PR). Like BAN2401, he continued to provide data presenting the results of the drug in the most favorable light possible (early results for aducanumab, the most recent analysis for BAN2401). I do not think many people will fall into this trap a second time.
Biogen can no longer rely on its Alzheimer's portfolio to support its actions. The development of the rest of its pipeline is now becoming more critical. And when the last of his Alzheimer's trials is over, he may decide to acquire companies pursuing a non-amyloid approach. Or, like so many other pharmaceutical companies that have adopted the anti-amlyoid approach before them, Biogen could completely withdraw from the Alzheimer's sector.
There may be some recovery after the selloff, but Biogen should stabilize fairly quickly. Buy now and sell soon may be the main short-term approach taken by some investors, but there does not seem to be much reason to believe that the current level of the stock will change substantially in the near future.
Disclosure: I / we have / we have no position in the actions mentioned, and we do not intend to initiate a position within the next 72 hours. I have written this article myself and it expresses my own opinions. I do not receive compensation for this (other than Seeking Alpha). I do not have any business relationship with a company whose actions are mentioned in this article.
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