ImmunoBrain Checkpoint (IBC) has announced the dosing of the first two patients in a Phase Ib trial of IBC-Ab002 to treat patients with early Alzheimer’s disease.
The randomised, double-blind, placebo-controlled, first-in-human Phase Ib IBC-01-01 clinical trial will assess the tolerability, safety, pharmacokinetics and exploratory markers of efficacy of the company’s lead programme IBC-Ab002 in these patients.
It comprises single and multiple ascending doses of IBC-Ab002 administered intravenously across up to five cohorts.
Patients with early Alzheimer’s disease will be randomised into a 3:1 ratio to receive IBC-Ab002 or placebo.
For the study, which will be carried out in Israel, the UK, and the Netherlands, IBC plans to enrol 40 subjects.
IBC co-founder and chief scientific officer professor Michal Schwartz said: “The initiation of our IBC-01-01 clinical investigation represents a significant milestone, not only for IBC but for the transformed understanding of brain-immune relationships.
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“After decades investigating the role of the immune system in brain aging and neurodegenerative disease, it is very exciting to advance this research into the clinic.”
The fully human anti-PD-L1 monoclonal antibody IBC-Ab002 harnesses the peripheral immune system and helps the brain overcome the multiple pathological factors which result in neurodegenerative disease progression and the cognitive manifestation.
IBC chief medical officer Robert Glanzman said: “We are excited about the clinical potential of IBC-Ab002, as it represents a truly novel and innovative therapeutic approach in the neurodegenerative disease space.”