First 100 Patients Enrolled in Phase 3 Trial of ScandiBio Therapeutics AI-developed Drug for Alzheimer´s Disease
Stockholm, 4 December, 2025 – ScandiBio Therapeutics AB today announced that the first 100 patients have been recruited to the multi-centre, 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 drug candidate CMA has been developed using AI-driven systems biology, yielding a rationally designed combination of metabolic activators that target multiple cellular pathways simultaneously. CMA is, to ScandiBio’s knowledge, the first AI-designed, systems biology-based combination therapy to advance into a human phase 3 clinical trial. The randomized, double-blind study is being conducted across nine clinical centers in Turkey and includes patients with mild, moderate, and severe Alzheimer’s disease. It represents one of the largest clinical programs to date aimed at targeting mitochondrial dysfunction in neurodegeneration.
“Mitochondrial dysfunction plays a key role in cognitive decline associated with
neurodegenerative diseases, including Alzheimer’s disease, as reported in
numerous recent scientific publications. However, addressing mitochondrial
dysfunction has proven challenging using traditional medicinal chemistry, given the
need to modulate several cellular pathways simultaneously,” says co-founder Dr. Mathias Uhlén.
Therefore, CMA is designed to address one of the underlying causes of mitochondrial dysfunction by enhancing NAD⁺ metabolism, stimulating fatty acid oxidation and reducing oxidative stress. The component N-acetyl cysteine aims to support glutathione synthesis, promoting antioxidant defense and toxin elimination, the component L-serine aids in neurotransmitter production and protects against neuroinflammation, L-carnitine enhances mitochondrial energy metabolism by facilitating transport of lipids to mitochondria and thus supports fat oxidation and the component NAD+ plays a central role in cellular metabolism and is essential for energy production, DNA repair, and cell signaling.
In a recent editorial in the journal Nature, ScandiBio’s co-founder and Chief Scientific Officer, Dr. Adil Mardinoglu, explains, “By integrating multi-omics data with advanced AI and systems biology approaches, we have been able to develop a therapeutic strategy based on combined metabolic activators.”
Dr. Olof Nord, the company’s CEO, comments, “Reaching more than 100 enrolled patients within just a few weeks across nine centers highlights the unmet need in Alzheimer’s disease, the strength of our clinical trial collaboration, and reinforces our ambition to create a new therapeutic class that complements and enhances existing treatments.”
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 clinical-stage 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 Therapeutics’ 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 Therapeutics undertakes no obligation to update forward looking statements except as required by law.
Read more:
Gustavsson M. Alzheimer angrips med cocktail som ska boosta små kraftverk. Dagens Medicin. 8 december 2025. Summary of the article in English
Anderberg T. ScandiBio Therapeutics Enters Phase III With Mitochondrial-Focused Alzheimer’s Treatment. BioStock. 11 November 2025.
The longevity opportunity: AI meets big biological data. Nature Portfolio – Advertisement Feature. 2025.
