Goradia Foundation grant focusing on potential long-term use of ACI-7104
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AC Immune has been awarded $4 million to extend the first part of an ongoing clinical trial that’s testing ACI-7104, its experimental vaccine targeting alpha-synuclein protein clumping, which is a hallmark of Parkinson’s disease.
The grant, funded by the Vijay and Marie Goradia Charitable Foundation, will allow the first part of the Phase 2 trial to be extended for an additional two years. The goal, according to a company press release announcing the research grant, is to establish the therapy’s long-term safety profile.
This will be particularly important for individuals with early disease, who are likely to require long-term treatment, according to the company.
The trial, dubbed VacSYn (NCT06015841), is assessing ACI-7104’s safety, pharmacological properties, and ability to elicit an immune response in an estimated 150 people with early Parkinson’s. Final data from this study part, through the two-year mark, are expected later this year, per AC Immune.
“We thank The Vijay and Marie Goradia Charitable Foundation for this grant in support of our efforts to develop ACI-7104 in early-stage [Parkinson’s disease],” said Martin Zügel, MD, AC Immune’s interim CEO designate and chair of the board of directors. “The grant will significantly impact the extension of Part 1 of the VacSYn trial and enable us to generate vital long-term data on the use of the product in patients.”
Parkinson’s is caused by the progressive loss of neurons in the brain that produce dopamine, a chemical messenger involved in motor control. The formation of toxic clumps of misfolded alpha-synuclein protein is believed to contribute to neurodegeneration and disease progression.
During the aggregation, or clumping, process, single alpha-synuclein molecules bind into oligomers, chain-like structures that continue to assemble into long, ordered fibers called amyloid fibrils. Researchers believe that oligomers are the most toxic form of alpha-synuclein because they can interfere with normal cell function.
ACI-7104 is an optimized vaccine formulation containing a lab-made small protein region of alpha-synuclein, which can trigger the production of antibodies against alpha-synuclein oligomers.
The treatment, given as an intramuscular injection, is expected to promote the clearance of alpha-synuclein aggregates and prevent further clumping, helping to slow or stop neurodegeneration in people with early Parkinson’s.
The first part of the VacSYn trial enrolled three groups of patients, each randomly assigned to receive ACI-7104 at different dosages, or a placebo, for nearly 1.5 years. After treatment came a six-month follow-up period.
In this first part, biomarker data are being used to adjust the dose and monitor disease-related biomarkers. In the second part, the study aims to provide early evidence of treatment benefit and monitor changes in motor and nonmotor symptoms, as well as digital, imaging, and biological biomarkers.
Interim data have shown the treatment had a favorable safety profile and that targeting alpha-synuclein protein clumping could slow disease progression.
“It is our hope that this grant will contribute to expanding our knowledge of [Parkinson’s] and to bringing ACI-7104 to patients in the earliest stages of disease, before its symptoms have irreversibly changed the lives of patients and their families,” Vijay Goradia said.
We are particularly excited and hopeful about the future potential for ACI-7104 to prevent [Parkinson’s], sparing other families from this disease altogether.
According to the company, “final results from Part 1 of the trial (to week-104) are expected in” the second half of this year.
“If realized, [ACI-7104’s] potential to slow the rate of progression would revolutionize the treatment of [Parkinson’s], preserving function and independence for individuals and bringing hope to millions,” Goradia said. “We are particularly excited and hopeful about the future potential for ACI-7104 to prevent [Parkinson’s], sparing other families from this disease altogether.”
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