LAUSANNE, Switzerland - AC Immune SA (NASDAQ: NASDAQ:ACIU), a clinical-stage biopharmaceutical company focusing on neurodegenerative diseases with a market capitalization of $310.67 million, announced interim safety results from its ABATE Phase 1b/2 trial evaluating ACI-24.060 in individuals with Down syndrome (DS). The trial, which aims to treat toxic forms of amyloid beta (Abeta), reported no serious adverse events or amyloid-related imaging abnormalities in the study's population.
The ongoing ABATE study is a double-blind, placebo-controlled trial designed to assess the safety, tolerability, and immunogenicity of ACI-24.060, as well as its pharmacodynamic effects. The interim analysis included data from subjects with DS who have been treated for up to one year with low-dose and mid-dose ACI-24.060. According to InvestingPro analysis, AC Immune maintains a strong financial position with more cash than debt on its balance sheet, providing stability for its clinical development programs.
Dr. Anke Post, Chief Medical (TASE:PMCN) Officer of AC Immune, remarked on the encouraging nature of these findings and their support for ACI-24.060 as a potential novel therapeutic option for people with DS. Dr. Mike Rafii, Medical Director of the Alzheimer’s Therapeutic Research Institute and Coordinating Principal Investigator of the study, emphasized the importance of safety in the DS population, who are at a high risk of developing Alzheimer’s disease.
AC Immune's investigational immunotherapy has been granted Fast Track designation by the U.S. FDA for the treatment of Alzheimer’s disease. This designation follows positive interim safety and tolerability data from Alzheimer's disease cohorts in the ABATE trial. The company will now proceed to evaluate a high dose of ACI-24.060 in additional DS patients, with ongoing recruitment in the U.S., U.K., and Spain.
ACI-24.060 is based on AC Immune's SupraAntigen® platform and targets Abeta 1-15, excluding T-cell epitopes. It has demonstrated the ability to induce a strong antibody response against key pathological forms of Abeta in preclinical studies. The therapy aims to inhibit plaque formation and increase plaque clearance, potentially reducing or preventing disease progression.
Individuals with Down syndrome have an extra copy of chromosome 21, which includes the gene for amyloid-precursor protein (APP). This overproduction of APP is believed to lead to the accumulation of Abeta plaques, which are indicative of Alzheimer’s disease. Nearly all individuals with DS develop these plaques, sharing similar pathophysiology and biomarkers with other forms of genetic Alzheimer’s disease.
AC Immune is recognized as a global leader in precision prevention for neurodegenerative diseases, with a diversified pipeline that includes several programs in advanced clinical stages. The company maintains a "GREAT" overall financial health score of 3.11 according to InvestingPro metrics, despite current market challenges, and appears undervalued based on comprehensive Fair Value analysis.
This report is based on a press release statement from AC Immune SA.
In other recent news, Swiss biopharmaceutical firm AC Immune SA has reported positive interim results from a Phase 2 clinical trial for its Parkinson's disease immunotherapy candidate, ACI-7104.056. The treatment has shown to generate anti-alpha-synuclein antibody levels significantly higher than those seen with a placebo, indicating a successful immune response. AC Immune plans to further assess the data and decide on the potential expansion of the trial in the first half of 2025.
In addition to the Parkinson's vaccine, AC Immune has made significant strides in Alzheimer's disease research. The company has maintained its Buy rating from H.C. Wainwright and BTIG, following successful prescreening in the Phase 2b ReTain trial for their Alzheimer's disease immunotherapy program, ACI-35.030. This achievement has led to a milestone payment from partner Janssen Pharmaceuticals, bolstering AC Immune's financial position.
AC Immune has also introduced a novel therapeutic antibody drug conjugate technology, morADC, aimed at treating neurodegenerative diseases. Furthermore, the company has entered into a global option and license agreement with Takeda Pharmaceutical Company (NYSE:TAK) Limited for the development of ACI-24.060, another potential Alzheimer's disease treatment. These recent developments reflect AC Immune's ongoing commitment to pioneering precision medicine for neurodegenerative diseases.
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