BAT4406F / Bio-Thera Solutions - LARVOL DELTA

Bio-Thera Solutions Publishes Phase I Clinical Study Results for BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorders (PRNewswire) - P1 | N=15 | NCT04146285 | Sponsor: Bio-Thera Solutions | "No subjects experienced DLT at the studied doses. BAT4406F injection has shown favorable safety, with most of the adverse events (AE) of CTCAE Grade 1 or 2 in severity, and no Grade ≥3 adverse drug reactions (ADR) or serious adverse reactions occurred in any subjects. With the dose increase of BAT4406F, Cmax, AUC0-t and AUC0-inf showed an increasing trend, whereas the CL, lZ, and Vd decreased. The mean elimination half-life (T1/2) ranged from 9.0-16.4 days. PK profile of BAT4406F was generally nonlinear. BAT4406F led to a rapid and significant B-cell depletion in all dose groups. Single dose of BAT4406F administration maintains B lymphocyte at a low level, and the duration of B lymphocyte suppression and depletion depends on the dose. During the observation period, 13 (86.7%) subjects remained relapse free and 2 (13.3%) subjects relapsed."

P1 data • PK/PD data • Neuromyelitis Optica Spectrum Disorder

First-in-Human Study of BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody in Patients With Neuromyelitis Optica Spectrum Disorders. (PubMed, CNS Neurosci Ther) - P1 | "BAT4406F was well tolerated at doses up to 750 mg and showed an expected pharmacodynamic effect of significant and long-term depletion of CD19+ B lymphocytes. It has also shown preliminary evidence of activity in NMOSD maintenance treatment, warranting further investigations."

Journal • P1 data • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - P2 | N=162 | Recruiting | Sponsor: Bio-Thera Solutions

New P2 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Bio-Thera Solutions | Unknown status ➔ Recruiting | N=48 ➔ 15 | Trial completion date: Dec 2021 ➔ Jun 2023 | Trial primary completion date: Dec 2021 ➔ Mar 2023

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • CD19