Bildnachweis: Priavoid, Galimedix.
Neurodegenerative diseases pose enormous challenges for societies and health- care systems. Two German biotech companies are taking different approaches, combining proprietary platforms with innovative financing strategies.
Diseases such as Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS) lead to the progressive and irreversible loss of nerve cells. According to medical societies, the number of people affected continues to rise as life expectancy increases. This creates immense economic costs for care and results in significant productivity losses. To date, drug treatments have focused primarily on alleviating acute symptoms. A permanent cure or a complete halt to nervecell damage and degeneration remains beyond the reach of research. One reason are socalled proteinopathies, in which misfolded proteins such as amyloid-beta, tau, or alpha-synuclein clump together. Chronic inflammation in the nervous system and dysfunction of the cells’ powerhouses further exacerbate the problem.
Developing new drugs is high-risk
The development of targeted drugs for neurodegener-ative diseases is considered particularly capitalintensive and high-risk within the pharmaceutical industry. According to industry analyses by IQVIA Biotech, the historical failure rate in phase II and phase III clinical trials is approximately 98%. A more recent study by the University of Illinois Chicago (2024) estimates that more than USD 100 billion has been invested worldwide in clinical trials for neurodegenerative diseases, concluding that almost all of this money has effectively been ‘lost’.1 The reasons for setbacks are diverse. Pathological processes often begin decades before the first symptoms appear, meaning that therapies frequently intervene too late. In addition, many drug candidates fail to cross the bloodbrain barrier in sufficient quantities. Novel antibodies have achieved initial regulatory ap- provals, but they carry risks of potentially dangerous swelling or bleeding in the brain, known as amyloid-related imaging abnormalities (ARIA).
Galimedix: A shield against toxic protein clusters
Against this backdrop, differentiated mechanisms are gaining importance. Biotech company Galimedix, with locations in the Bavarian village Martinsried and the US, is pursuing a preventive molecular approach. At the heart of its platform is the orally administered molecule GAL-101. It specifically targets the toxic aggregation of amyloid-beta before larger deposits can form. In an initial clinical phase I study in healthy volunteers, the company demonstrated a favourable safety profile and successful penetration of the blood-brain barrier. Explaining the company’s financing history, Dr Alexander Gebauer, co-founder and executive chairman of Galimedix Therapeutics Inc., says: ‘After founding the company with our own funds and support from “family and friends,” we were quickly able to attract two venture capital investors for the first financing round. Our series A was funded primarily by our strategic partner and investor Théa Open Innovation (TOI).’ New funding will be required for the upcoming phase II study in Alzheimer’s disease. Gebauer announces: ‘In our series B, we plan to raise the financial resources we need to conduct phase II studies in both Alzheimer’s disease and at least one additional indication.’ In discussions with investors, Gebauer emphasises the company’s differentiated profile: ‘Firstly, our approach differs significantly from other amyloid-beta programmes: our primary objective is not to dissolve existing plaques, but to prevent the formation of toxic amyloid aggregates. Secondly, we are building on the excellent preclinical and clinical data that our drug candidate GAL-101 has already demonstrated in previous studies.’ Gebauer sees major opportunities in avoiding biological large molecules: ‘Based on the study data already available, we expect our therapy to offer a significant benefit to patient -both the anti-amyloid antibodies that have already been approved and those that have failed in clin- ical development have unfortunately caused serious side effects, known as ARIAs. At the same time, their efficacy in terms of patientrelevant endpoints has so far not been truly convincing. A safe and effective small molecule such as GAL-101 therefore has the potential to become the new “standard of care”.’ With regard to Germany as a location for biotech, Gebauer calls for reforms: ‘I would like to see small biotech companies in particular gain better access to government funding programmes. In addition, the regulatory framework, especially for early-stage clinical trials in the EU and therefore in Germany, is significantly less favourable than in countries such as the US or Australia. When it comes to private venture capital, we are a long way from having an investment culture comparable with that in the UK, US, or China.’
Priavoid: Targeted disassembly of toxic oligomers
Düsseldorf-based Priavoid is pursuing an alternative approach. The company uses a proprietary peptide technology to directly dissolve toxic oligomers that have already formed in the brain, without triggering inflammatory reactions. Its lead drug candidate, PRI-002, is currently in an advanced phase II clinical trial in patients with Alzheimer’s disease. CEO Philipp Bürling points out the company’s distinctive financing model: ‘For one thing, the Federal Agency für Break through Innovation (SPRIND) funding was a strong external validation of our scientific approach. Being able to finance the phase II study in full through the SPRIND subsidiary PRInnovation is crucial and has enabled us to keep our focus on scientific and clinical development. In the long run, every biotech company needs the right partners and investors to support further development and eventual commercialisation. At this stage, we are keeping all options open as we consider our next steps.’ Looking ahead to the up coming study data readout, Bürling explains: ‘The blinded safety data currently available, together with the recommendation of the independent Drug Safety Monitoring Board, which had access to the unblinded safety data, to continue the PRImus-AD study without further ARIA monitoring, gives us confidence.’ The CEO takes a broader view when considering the risks of failure: ‘With PRI-002, we are not targeting amyloid plaques, but neurotoxic amyloid-beta oligomers, which are considered particularly relevant drivers of the disease. Moreover, Priavoid is much more than a single development programme. Our Detangler platform has the potential to address disease-relevant protein aggregates across a range of neurodegenerative diseases, including Alzheimer’s, Parkinson’s, and ALS.’ Regarding the value proposition for investors, Bürling highlights the differentiation from antibodies: ‘Our all-D-peptide candidate uses a completely different, non-immunogenic mechanism of ac- tion: it is designed to disassemble neurotoxic amyloid oligomers into naturally occurring, harmless monomers and thereby neutralise them.’ Bürling describes the next steps as follows: ‘We are currently focusing on the upcoming data update from our phase II PRImus-AD study, which is planned for the second half of 2026. This data will play a key role in shaping the further development of PRI-002. Once we have the complete data set, we will conduct a thorough analysis of the results and, on this basis, determine the next regulatory, clinical, and strategic steps.’
