An Israeli-developed antibody therapy designed to restore immune protection in the brain has demonstrated a favorable safety profile in its first human trial, according to Phase 1 clinical results published in Nature Medicine.
Alzheimer's disease is the most common form of dementia, a progressive disorder affecting memory, thinking and daily functioning. The World Health Organization reports that more than 55 million people worldwide live with dementia, with Alzheimer's accounting for an estimated 60% to 70% of cases. Currently, no cure exists; available treatments manage symptoms, while newer drugs may modestly slow cognitive decline.
The experimental treatment, an antibody called IBC-Ab002, is based on research by Professor Michal Schwartz of the Weizmann Institute of Science's Brain Sciences Department. Unlike most current Alzheimer's therapies that target amyloid plaques - abnormal protein deposits long considered central to the disease - IBC-Ab002 aims to restore immune functions that decline with age. "The goal of our biological therapy is to restore the immune system's youthful capacity to protect the brain," Schwartz said.
Schwartz, an Israel Prize recipient in Life Sciences, has previously demonstrated that the brain depends on the immune system throughout life for maintenance and repair, contradicting the longstanding assumption that the brain operates independently of immune activity. She identified age-related immune decline as contributing to brain inflammation, a major factor in neurodegeneration, suggesting that removing amyloid plaques alone may be insufficient to halt the disease.
About a decade ago, Schwartz's team found in mouse models that temporarily releasing certain immune "brakes" Helped clear aging cells from the brain, reduce inflammation and ease symptoms. Researchers identified the PD-1/PD-L1 immune checkpoint pathway as a potential treatment target, though results were limited to animal studies.
Schwartz co-founded ImmunoBrain to develop therapies based on her research. The company licensed technology from Yeda, the Weizmann Institute's technology transfer arm, and created IBC-Ab002, a humanized antibody designed to target the immune mechanism identified in her laboratory. Though it targets the same PD-L1 molecule involved in some cancer immunotherapies, IBC-Ab002 was engineered specifically for Alzheimer's treatment.
The trial involved 40 early-stage Alzheimer's patients at 11 medical centers in the United Kingdom, Israel and the Netherlands. The treatment proved safe and well tolerated at all tested doses. The drug's biological activity matched its design, and it reduced biomarkers associated with neuronal damage and synaptic loss.
Since Phase 1 trials primarily assess safety rather than effectiveness, results do not show whether the treatment slows or reverses Alzheimer's. However, researchers noted that the safety profile combined with reduced damage-related biomarkers supports continued clinical development.