Roche-Partnered Alzheimer's Drug Sent AC Immune Stock

AC Immune SA – NASDAQ:ACIU – Alzheimer’s disease – Stock

AC Immune (ACIU) said Tuesday its Roche (RHHBY)-partnered drug slowed cognitive decline in Alzheimer‘s patients in a midstage test, and ACIU stock rocketed to a six-month high.

The drug targets tau, a protein that causes problems when it misfolds and becomes tangled in the brain. On an 11-item scale of cognition, the drug called semorinemab slowed cognitive decline by 43.6% vs. patients’ baselines, AC Immune said in a news release.

AC Immune Chief Executive Andrea Pfeifer noted this is the first time a tau-directed drug has shown a benefit on cognition in mild to moderate Alzheimer’s patients. But she also noted the test was short at just 49 weeks. So, the companies will continue with another test.
“Alzheimer’s disease is a slow-moving chronic disease, and this small trial was relatively short, 49 weeks; so the data from the open-label extension may be important in elucidating the potential of semorinemab in this patient population,” she said in a written statement.
In morning trading on the stock market today, ACIU stock soared 68.2% near 11.80.

ACIU Stock Soars On Alzheimer’s Data

AC Immune and Roche looked for improvement on four scales of cognition. Just one passed muster — the Alzheimer’s Disease Assessment Scale Cognitive Subscale, 11-item Version. On that scale, semorinemab-treated patients experienced a nearly 44% reduction in cognitive decline.

ACIU Stock: Over 65% Increase Pre-Market Explanation

The stock price of AC Immune SA (NASDAQ: ACIU) increased by over 65% pre-market. This is why it happened.

The stock price of AC Immune SA (NASDAQ: ACIU) – a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases – increased by over 65% pre-market. Investors are responding positively to AC Immune SA announcing that Genentech (a member of the Roche Group) has informed them that Lauriet, a placebo-controlled Phase 2 study evaluating the safety and efficacy of the investigational anti-tau monoclonal antibody, semorinemab, in mild-to-moderate Alzheimer’s disease (AD), met one of its co-primary endpoints, ADAS-Cog11. And the second co-primary endpoint, ADCS-ADL, was not met. The safety data showed that semorinemab is well tolerated with an acceptable safety profile and no unanticipated safety signals.
Semorinemab had demonstrated a statistically significant reduction in cognitive decline from the baseline by 43.6% compared to placebo (p<0.0025) as measured by the Alzheimer’s Disease Assessment Scale, Cognitive Subscale, 11-item Version (ADAS-Cog11) at week 49 in people with mild-to-moderate AD (i.e., Mini-Mental State Examination (MMSE) 16-21).

There was no effect on the other co-primary endpoint of reducing the rate of functional decline from the baseline as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) or secondary efficacy endpoints for the Mini-Mental State Examination (MMSE) or the Clinical Dementia Rating-Sum of Boxes (CDR-SB). And the safety was consistent with previous clinical data reported.
Genentech reported that the open label portion of the study will continue as planned. Further analyses are ongoing and the top-line data will be submitted for presentation at the CTAD conference (Clinical Trials on Alzheimer’s Disease conference) in November.

AC Immune Soars on Alzheimer’s Drug Trial Results

An experimental Alzheimer’s therapy developed by AC Immune SA and Roche Holding AG slowed patients’ rate of cognitive decline in a study, another hopeful sign for a field that’s faced years of setbacks.

The antibody, known as semorinemab, targets a protein called tau that’s thought to play a role in Alzheimer’s. The treatment reduced cognitive decline from baseline by 43.6% compared to placebo in people with mild-to-moderate disease, AC Immune said Tuesday. Researchers didn’t see an impact on functional decline, the other main target of the study, and the experimental drug failed to meet some secondary goals.

Alzheimer’s is in the spotlight after the controversial recent approval in the U.S. of Biogen Inc.’s Aduhelm, seen as a positive sign for other drugmakers such as Roche. Despite the mixed results, the 272-patient study is the first time that an anti-tau antibody has been able to show a therapeutic effect, AC Immune said. Most Alzheimer’s treatments have focused on reducing another disease-related protein, called amyloid.

“This is what we were all waiting for,” Chief Executive Officer Andrea Pfeifer said in an interview. “This study brings credibility to the field. We have not answered all the questions obviously. We don’t have all the clarity on the data, but it brings back solid clinical assessment. It brings back tau as a target.”

The shares surged 63% as of 8:49 a.m. in New York in trading before U.S. markets opened.

Roche said it will continue monitoring patients in the open-label portion of the study in order to understand the mixed results. The Swiss drug giant called the results “another important step in our understanding of the role of tau.”

It’s still uncertain what AC Immune’s findings could mean for patients. The trial was relatively short, and further data may be important in understanding the potential of the experimental treatment, according to the company. More detailed results are expected to be presented in November.

“While I’m really excited about the data,” AC Immune’s Pfeifer said, “I’m also very prudent.”

Alzheimer’s disease

Alzheimer’s disease (AD) is a neurodegenerative disease that usually starts slowly and progressively worsens.

It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems with language, disorientation (including easily getting lost), mood swings, loss of motivation, self-neglect, and behavioral issues.

As a person’s condition declines, they often withdraw from family and society. Gradually, bodily functions are lost, ultimately leading to death. Although the speed of progression can vary, the typical life expectancy following diagnosis is three to nine years.

About AC Immune SA

AC Immune SA is a Switzerland-based clinical-stage biopharmaceutical company.

The Company focuses on precision medicine for neurodegenerative diseases. It designs, discovers and develops therapeutic, as well as diagnostic products for prevention, diagnosis and treatment of diseases caused by misfolding proteins. Its SupraAntigen and Morphomer technology platforms to create antibodies, small molecules and vaccines designed to address a broad range of neurodegenerative indications, such as Alzheimer’s disease (AD).

The Company’s pipeline includes nine therapeutic product candidates with five in clinical trials, and three diagnostic candidates. Its lead product candidate is Crenezumab, a humanized and monoclonal anti-Abeta antibody for Alzheimer’s disease. It has collaborations with pharmaceutical companies, including Roche/Genentech, Eli Lilly, Biogen, Janssen Pharmaceuticals, Nestle Institute of Health Sciences, Life Molecular Imaging (formerly Piramal Imaging) and Essex Bio-Technology.