BAT4406F / Bio-Thera Solutions - LARVOL DELTA

Bio-Thera: BAT4406F injection has been approved for clinical trial with new indication of minimal change nephropathy/focal segmental glomerulosclerosis [Google translation] (Eastmoney.com) - "Nanfang Finance reported on July 21 that Bio-Thera...announced that the company received the 'Drug Clinical Trial Approval Notice' issued by the National Medical Products Administration for the new minimal change nephropathy/focal segmental glomerulosclerosis indication for BAT4406F injection. BAT4406F is a fully human anti-CD20 antibody developed by the company, and the approved clinical trial indications include neuromyelitis optica spectrum disorder, minimal change nephropathy/focal segmental glomerulosclerosis."

New trial • Immunology • Neuromyelitis Optica Spectrum Disorder

A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Bio-Thera Solutions | Recruiting ➔ Completed

Trial completion • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

IDMC Provides Positive Recommendation for Bio-Thera Solution's BAT4406F (ADCC-Enhanced Anti-CD20 mAb) in Neuromyelitis Optica Spectrum Disorder Based on Interim Analysis of Pivotal Phase II/III Trial (PRNewswire) - P2/3 | N=162 | CTR20231610 | Sponsor: Bio-Thera Pharmaceuticals Co., Ltd. | "Bio-Thera Solutions...announced that the Independent Data Monitoring Committee (IDMC) has recommended early study termination for the pivotal Phase II/III trial of BAT4406F in neuromyelitis optica spectrum disorder (NMOSD) based on positive interim analysis results. Following this recommendation, Bio-Thera has decided to close patient enrollment ahead of schedule....Following a formal review of interim data, the IDMC concluded that BAT4406F demonstrated statistically significant efficacy, meeting the pre-defined superiority criteria, and recommended early trial termination due to compelling efficacy. Based on this recommendation, Bio-Thera has decided to close enrollment ahead of schedule and begin preparation to file for regulatory approval from NMPA. In addition, Bio-Thera intends to explore the safety and efficacy of BAT4406F in other indications."

DSMB • Enrollment closed • P2/3 data • Trial termination • Immunology • Neuromyelitis Optica Spectrum Disorder

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