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<\/strong> said in a news release.<\/p>\n 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. AC Immune and Roche looked for improvement on four scales of cognition. Just one passed muster \u2014 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.<\/p>\n <\/p>\n The stock price of AC Immune SA (NASDAQ: ACIU) increased by over 65% pre-market. This is why it happened.<\/p>\n The stock price of AC Immune SA (NASDAQ: ACIU) \u2013 a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases \u2013 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\u2019s 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. 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\u2019s 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. <\/p>\n also read :<\/p>\n An experimental Alzheimer\u2019s therapy developed by AC Immune SA and Roche Holding AG slowed patients\u2019 rate of cognitive decline in a study, another hopeful sign for a field that\u2019s faced years of setbacks.<\/p>\n The antibody, known as semorinemab, targets a protein called tau that\u2019s thought to play a role in Alzheimer\u2019s. 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\u2019t see an impact on functional decline, the other main target of the study, and the experimental drug failed to meet some secondary goals.<\/p>\n Alzheimer\u2019s is in the spotlight after the controversial recent approval in the U.S. of Biogen Inc.\u2019s 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\u2019s treatments have focused on reducing another disease-related protein, called amyloid.<\/p>\n \u201cThis is what we were all waiting for,\u201d Chief Executive Officer Andrea Pfeifer said in an interview. \u201cThis study brings credibility to the field. We have not answered all the questions obviously. We don\u2019t have all the clarity on the data, but it brings back solid clinical assessment. It brings back tau as a target.\u201d<\/p>\n The shares surged 63% as of 8:49 a.m. in New York in trading before U.S. markets opened.<\/p>\n 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 \u201canother important step in our understanding of the role of tau.\u201d<\/p>\n It\u2019s still uncertain what AC Immune\u2019s 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.<\/p>\n \u201cWhile I\u2019m really excited about the data,\u201d AC Immune\u2019s Pfeifer said, \u201cI\u2019m also very prudent.\u201d<\/p>\n <\/p>\n\n
“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.<\/p>\nACIU Stock Soars On Alzheimer’s Data<\/h2>\n
ACIU Stock: Over 65% Increase Pre-Market Explanation<\/h2>\n
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\u2019s 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).<\/p>\n
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\u2019s Disease conference) in November.<\/p>\n\n
AC Immune Soars on Alzheimer\u2019s Drug Trial Results<\/h2>\n\n\n
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