ADX-001 / Adaxion Therapeutics - LARVOL DELTA

A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Adaxion Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response (clinicaltrials.gov) - P1 | N=88 | Not yet recruiting | Sponsor: Adaxion Therapeutics

New P1 trial

ADX-001, A Novel Hypoimmunogenic, Half-life Extended Anti-TNFα/IL-23p19 Bispecific Antibody for Inflammatory Disease (ACR Convergence 2026) - "ADX-001 is a novel hypoimmunogenic anti-TNFα/IL-23p19 bispecific antibody offering a promising therapeutic advancement for inflammatory indications by improving efficacy over monotherapies, minimizing immunogenicity risks, and providing a more streamlined and patient-friendly dosing regimen. ADX-001 is currently in IND-enabling studies with a projected Phase 1 initiation in Q4 2026. ADX-001, containing conjugated CD22Ls, suppresses ADA titers (A), and rescues the pharmacokinetics (PK) in (B) in B6-hFcRn knock-in mice following 4 weekly subcutaneous injections at 4mg/kg"

Bispecific • Gastroenterology • Gastrointestinal Disorder • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Seronegative Spondyloarthropathies • CD22

Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Alzeca Biosciences, Inc.

First-in-human • New P1 trial • Alzheimer's Disease • CNS Disorders

Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease (clinicaltrials.gov) - P1 | N=16 | Terminated | Sponsor: Alzeca Biosciences, Inc. | Recruiting ➔ Terminated; A temperature excursion occurred at the drug supplier's storage facility, which led to the loss of a significant portion of the IMP stock. Consequently, there is not enough IMP available to support continued recruitment

First-in-human • Trial termination • Alzheimer's Disease • CNS Disorders

Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Alzeca Biosciences, Inc. | Initiation date: Jul 2022 ➔ Nov 2022

First-in-human • Trial initiation date • Alzheimer's Disease • CNS Disorders

Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Alzeca Biosciences, Inc. | Trial completion date: Jun 2024 ➔ Jan 2025 | Trial primary completion date: Jun 2024 ➔ Jan 2025

First-in-human • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders