ScandiBio Therapeutics AB Announces Initiation of Phase 3 Clinical Trial of Combined Metabolic Activators (CMA) for Alzheimer’s Disease
Alzheimer’s disease (AD) is the most common cause of dementia, which is a general term for memory loss and other cognitive impairments that are significant enough to interfere with daily life. A growing body of evidence suggests that impaired brain energy metabolism and mitochondrial dysfunction may contribute to cognitive decline in AD. In this trial, the aim is to improve mitochondrial dysfunction by treating patients with the proprietary Combined Metabolic Activator (CMA2) drug.
Stockholm, Sweden – November 4, 2025– ScandiBio Therapeutics AB today announced the initiation of a multicentre, phase 3 human clinical trial evaluating the efficacy and safety of their pharmaceutical, Combined Metabolic Activator (CMA), in patients with Alzheimer’s disease (AD). The trial is taking place across nine clinical centres in Turkey and targets patients with mild, moderate and severe symptoms. CMA is designed to address one of the underlying causes of disease progression: mitochondrial dysfunction by enhancing NAD⁺ metabolism, stimulating fatty acid oxidation and reducing oxidative stress.
CMA is a formulation taken orally and consist of L-serine, N-acetyl-L-cysteine (NAC), nicotinamide and L-carnitine tartrate. Earlier phase 2 clinical studies have demonstrated that CMA improves cognitive performance and favourably modulates systemic metabolic pathways with a strong safety and tolerability profile. These findings form the basis of the current phase 3 trial, involving over 600 patients. This trial represents one of the largest clinical programmes to date to target mitochondrial dysfunction in neurodegeneration.
Dr Olof Nord, the company’s CEO, comments, “We are delighted to announce the successful initiation of our phase 3 trial and the enrolment of the first patients.” Dr Mathias Uhlén (professor at KTH), chairman of the board of directors, adds: “Alzheimer’s disease remains one of the greatest medical challenges of our time. The launch of this phase 3 study marks a significant milestone in our journey from systems biology research to clinical translation.”
Dr Adil Mardinoglu (professor at King’s College London and associate professor at KTH), Chief scientific officer and co-founder of the company, comments, “Backed by extensive preclinical, multi-omics and early clinical data, CMA represents a novel therapeutic strategy that could transform how we treat neurodegenerative disorders. By addressing mitochondrial dysfunction, a fundamental driver of disease progression, CMA has the potential to modify the course of Alzheimer’s disease and improve cognitive function.”
The recruitment of patients is ongoing with 60+ patients recruited so far and ScandiBio Therapeutics expects to complete the study during the latter part of 2026.
Contact: Dr Olof Nord, CEO, +46-70 350 20 88, Olof.Nord@scandibio.com
ScandiBio Therapeutics, Stockholm, Sweden
ScandiBio Therapeutics is a biotechnology company founded by researchers from KTH Royal Institute of Technology, Karolinska Institutet and Sahlgrenska Academy in Sweden, and is part of Navigare Ventures’ venture portfolio (www.navigareventures.com).
Its science originates from research conducted at the Science for Life Laboratory in Stockholm, led by Dr Adil Mardinoglu (professor at King’s College London and associate professor at KTH) and Dr Mathias Uhlén (professor at KTH), and Dr Jan Boren (professor at the Sahlgrenska Academy in Gothenburg). The company has developed an AI-based modelling platform for biology and medicine with the potential to treat diseases involving metabolic dysfunction. The company has developed drug candidates consisting of a combination of several metabolic activators aimed at improving the condition of patients with mitochondrial dysfunction. A large number of human clinical trials have been conducted to treat various diseases, including patients with conditions such as non-alcoholic fatty liver disease (NAFLD), Alzheimer’s disease, Parkinson’s disease and patients with SARS-CoV-2 infection. For more information, see: www.scandibio.com
Science for Life Laboratory, Stockholm, Sweden
The Science for Life Laboratory (SciLifeLab) is a research institution dedicated to advancing molecular biosciences in Sweden. It started out in 2010 as a collaboration between four universities: Karolinska Institutet, KTH Royal Institute of Technology, Stockholm University and Uppsala University. The centre provides thousands of researchers with access to a variety of advanced life science infrastructures, creating a unique environment for health and environmental research at the highest level. For more information, see: www.scilifelab.se
KTH Royal Institute of Technology, Stockholm, Sweden
Since its foundation in 1827, KTH Royal Institute of Technology in Stockholm has grown to become one of Europe’s leading technical and engineering universities, as well as a key centre of intellectual talent and innovation. Sweden’s largest technical research and learning institution, KTH is home to students, researchers and faculty from around the world who are dedicated to advancing knowledge. For more information, see: www.kth.se
King’s College London, UK
King’s College London is one of the top 35 universities in the UK and one of the top 10 in Europe (QS World University Rankings, 2020/21). It is also one of the oldest universities in England. It has more than 31,000 students (including over 12,800 postgraduates) from around 150 countries, as well as around 8,500 members of staff. The college has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF), 84% of King’s research was rated ‘world-leading’ or ‘internationally excellent’ (3* or 4*). For more information, see: https://www.kcl.ac.uk
Forward looking statements
This press release contains forward looking statements, including, but not limited to, statements regarding the design, conduct, timing, and potential outcomes of ScandiBio’s clinical programme. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. CMA has not been approved for any indication. ScandiBio undertakes no obligation to update forward looking statements except as required by law.
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English summary of the Swedish article in Life Science Sweden
Dagens Industri: ScandiBio Therapeutics AB Announces Initiation of Phase 3 Clinical Trial of Combined Metabolic Activators (CMA) for Alzheimer’s Disease
Photo in full resolution: Mathias Uhlen (Photo by Gustav Ceder)
