EI1071 / Elixiron Immunotherap, 4B Technologies - LARVOL DELTA

ENRUPATINIB, A BRAIN -PENETRANT CSF -1R INHIBITOR, REDUCES NEUROINFLAMMATION AND ENHANCES COGNITIVE FUNCTION IN ANIMAL MODELS OF ALZHEIMER'S DISEASE (ADPD 2025) - "EI-1071) is a highly selective CSF -1R inhibitor with BBB -permeability, currently in a phase II trial for AD... Enrupatinib is effective in reducing neuroinflammation and attenuating mem ory impairment, which holds therapeutic potential for AD."

Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • CSF1R • TREM2 • TYROBP

Drug Development. (PubMed, Alzheimers Dement) - P1 | "1. EI-1071 is effective in reducing activated microglia, neuroinflammation and neuronal injuries, resulting in a significant improvement of memory function in the 5xFAD model. 2. EI-1071 is well-tolerated in a phase 1 clinical trial. The safety profile supports further investigation in patients with AD."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • TYROBP

A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Elixiron Immunotherapeutics Limited

New P2 trial • Alzheimer's Disease • CNS Disorders • Inflammation

Safety of the CSF1R Inhibitor EI-1071 in Human and Its Pharmacological Effects to Reduce Neuroinflammation and Improve Memory Function in a Mouse Model of Alzheimer’s Disease (AAIC 2024) - P1 | "EI-1071 is effective in reducing activated microglia, neuroinflammation and neuronal injuries, resulting in a significant improvement of memory function in the 5xFAD model. EI-1071 is well-tolerated in a phase 1 clinical trial. The safety profile supports further investigation in patients with AD."

Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • TYROBP

A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Elixiron Immunotherapeutics Inc. | Unknown status ➔ Completed | Trial completion date: Dec 2020 ➔ Jan 2022 | Trial primary completion date: Jul 2020 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date • CSF1

Elixiron Immunotherapeutics Announces Orphan Drug Designation Granted to CSF-1R Inhibitor, EI-1071 for the Treatment of Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Elixiron Immunotherapeutics...announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its colony stimulating factor‑1 receptor (CSF‑1R) inhibitor, EI‑1071 for the treatment of idiopathic pulmonary fibrosis (IPF)....'Building on promising data from preclinical and phase I studies, we are actively evaluating options to accelerate the development of EI‑1071 to address unmet medical needs.'"

Orphan drug • Idiopathic Pulmonary Fibrosis