enrupatinib (EI-1071) / Elixiron Immunotherap, 4B Technologies - LARVOL DELTA

EI-1071-202: 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=7 | Completed | Sponsor: Elixiron Immunotherapeutics Inc. | Recruiting ➔ Completed | N=15 ➔ 7 | Trial completion date: Dec 2026 ➔ May 2026 | Trial primary completion date: Dec 2026 ➔ Mar 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Inflammation

Transcriptomic Insights Of Enrupatinib Administration In Alzheimer's Disease Mouse Models (AAIC 2026) - No abstract available

Preclinical • Alzheimer's Disease • CNS Disorders

Elixiron Immunotherapeutics Reports Positive Phase 2 Interim Results for Enrupatinib: Evidence of Neuroinflammation Reduction and Early Cognitive Benefit in Alzheimer's Disease (The Manila Times) - "Favorable Safety and Tolerability Profile: No drug-related serious adverse events have been observed to date across all evaluable participants (n=7)...Proof of Target Engagement: Within a biomarker-defined subgroup, 80% (4 out of 5) of participants showed TSPO-PET signal reductions exceeding 30% on average from baseline across multiple prespecified brain regions, with a significant reduction...One TSPO-PET responder demonstrated marked improvements across all exploratory cognitive and functional assessments, most notably an 8-point increase in MMSE score from baseline...Elixiron plans to initiate a placebo-controlled study enriched for likely responders using the predictive biomarker identified in this interim analysis, with the goal of confirming enrupatinib's efficacy in a precision-selected patient population."

New trial • P2 data • Alzheimer's Disease

EI-1071-202: 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 (Hong Kong) Ltd. | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Inflammation

Drug Development. (PubMed, Alzheimers Dement) - "These findings underscore the pharmacological potential of enrupatinib in mitigating Alzheimer's disease-related pathologies. By reducing neuroinflammation and preserving neuronal integrity, enrupatinib offers a promising therapeutic avenue for Alzheimer's disease."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation

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