TSRA-196 / Tessera Therapeutics, Regeneron - LARVOL DELTA

TSRA196-AAT-201: A Phase 1/2, Open?Label, Multi?Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA?196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated With Severe Alpha?1 Antitrypsin Deficiency (clinicaltrialsregister.eu) - P1/2 | N=10 | Not yet recruiting | Sponsor: Tessera Therapeutics Inc.

New P1/2 trial • Alpha-1 Antitrypsin Deficiency • Genetic Disorders • Hepatology • Pulmonary Disease • Respiratory Diseases

A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD) (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: Tessera Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ Apr 2026

Enrollment open • Trial initiation date • Alpha-1 Antitrypsin Deficiency • Genetic Disorders • Hepatology • Pulmonary Disease • Respiratory Diseases

Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In Vivo Gene Editing Program TSRA-196 for the Treatment of Adults with AATD (GlobeNewswire) - "Tessera recently initiated a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of TSRA-196 in adults with AATD. In this first-in-human, open-label, multi-national study, trial participants will receive a single intravenous administration of TSRA-196 and be followed longitudinally for safety and key biomarkers relevant to AAT expression and function."

Fast track • First-in-human • Orphan drug • Trial status • Alpha-1 Antitrypsin Deficiency