Indivi and Clouds of Care, two independent TechBio companies, today announced a strategic partnership to advance the use of precision medicine tools in early-phase neuroscience drug development, targeting Alzheimer’s and Parkinson’s disease.
The field of neurodegeneration remains one of the toughest challenges in medicine, with a historically low probability of technical and regulatory success (PTRS). The highest attrition occurs between First-in-Human and Proof-of-Concept studies, where conventional endpoints lack the sensitivity needed to detect early treatment effects.
“Age being the principal risk factor for neurodegenerative diseases, we are facing a global pandemic,” says Michel Vounatsos, Chair of the Board of Directors of Clouds of Care. “Deep phenotyping technologies will be essential to improve drug development success in Alzheimer’s and Parkinson’s Disease and extend healthy brain ageing across the lifespan.”
The partnership will integrate world-class expertise in neuro-electrophysiology (resting-state EEG, event-related potentials, and polysomnography) with digital health technology tools. Together, they aim to establish a unified R&D framework for multimodal deep phenotyping, combining biological (electrophysiology-based) and functional (cognitive and motor behavior) measures to deliver earlier, more definitive Proof-of-Biology (PoB) and Proof-of-Concept (PoC) signals in early drug development trials.
This collaboration creates a technology-integrated value proposition, which de-risks early clinical development, by increasing the signal-to-noise ratio of PoB-PoC endpoints, thereby enhancing the PTRS, and potentially improving the risk-adjusted Net Present Value (rNPV) and accelerating time-to-market for biopharmaceutical partners.
The initiative aligns with the European Medicines Agency’s (EMA) recent call for updated guidelines on early Alzheimer’s trials, emphasizing the need for more responsive and clinically meaningful endpoints in early clinical phases.
“It is not just about bringing deep phenotyping technologies together,” says Shibeshih Mitiku Belachew, Chief Medical Officer of Indivi. “It is about creating a true symbiosis between clinical development and the science of enabling technologies to design smarter, faster, and more successful trials.”
