The ardor for shares of AC Immune SA (ACIU, Financial) has cooled considerably since the company’s Aug. 31 announcement of somewhat promising study results for its Alzheimer's drug. The Swiss biotech’s stock shot up to a 52-week high of $12.61, but has since been halved as investors questioned how meaningful the trial results were.
In the small test, AC Immune’s drug, semorinemab, cut cognitive decline compared with a placebo among people with mild or moderate Alzheimer’s, the company said in a statement. That’s the good news.
AC Immune is developing an Alzheimer's drug that uses a new approach called the tau theory. (Photo courtesy of AC Immune.)
The bad news is the drug failed to meet three other study goals. This leaves Alzheimer’s researchers to ponder whether the treatment did anything to slow the progression of the disease.
Some analysts were caught off guard by the announcement. Endpoints News reported that Jefferies analyst Lucy Codrington was taken aback by the modestly encouraging data given a trial last September failed to show the treatment had any impact on cognition and function among patients in early stages of the disease.
Her opinion was seconded by SVB Leerink’s Marc Goodman, who wrote that investors “had minimal expectations” for this readout. He thinks the data provide initial clinical validation of the AC Immune approach, even though “the lack of consistency remains a significant issue that needs to be further analyzed.”
AC Immune CEO Andrea Pfeifer, Ph.D., was far more enthusiastic, calling the study results ”remarkable in that they are the first in the anti-tau theory." Many of the results from recent Alzheimer’s therapies have focused on the amyloid theory.
Alzheimer’s is not well understood, but many in the field believe abnormal proteins called beta amyloid cluster in the brain and interrupt cell function. Another protein, called tau, strings together in the part of the brain involved in memory and forms tangles inside neurons that block cells from talking with each other. When amyloid builds up into plaques, it pushes the tau throughout the brain.
Drug developers believe that if they can clear these plaques or the tau tangles, they could address the underlying cause of Alzheimer’s.
Biogen Inc.’s (BIIB, Financial) controversial Alzheimer’s medication, Aduhelm, which was recently approved by the Food and Drug Administration, operates on the beta amyloid theory, as does Eli Lilly and Co’s. (LLY, Financial) donanemab, which the company plans to submit to the FDA later this year.
AC Immune plans to continue analyzing the data from the semorinemab study and extend the open-label (where both the health providers and the patients are aware of the drug or treatment being given) portion of the study.
The company says its pipeline includes nine therapeutic and three diagnostic product candidates aimed at improving the treatment of a broad spectrum of Alzheimer’s and neurodegenerative diseases. The company has multiple partnerships with major pharmaceutical companies, including Roche Holding AG (RHHBY, Financial), Eli Lilly and Johnson & Johnson’s (JNJ, Financial) Janssen unit worth up to $3 billion in potential milestones.
AC Immune is rated a strong buy by two analysts and a buy by a third. It has an average target price of $15.22, according to Yahoo Finance.
