PLX 200 / Polaryx - LARVOL DELTA

Polaryx Therapeutics Inc…announced today that the U.S. Food and Drug Administration has granted Fast Track Designation to PLX-200 for the treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis, also known as CLN2 disease. (Investing.com)

Fast track • Rare Diseases

Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3 (clinicaltrials.gov) - P3 | N=39 | Not yet recruiting | Sponsor: Polaryx Therapeutics, Inc. | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • CNS Disorders

Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3 (clinicaltrials.gov) - P3 | N=39 | Not yet recruiting | Sponsor: Polaryx Therapeutics, Inc. | Trial completion date: Aug 2024 ➔ Dec 2025 | Trial primary completion date: Feb 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders

Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3 (clinicaltrials.gov) - P3; N=39; Not yet recruiting; Sponsor: Polaryx Therapeutics, Inc.; Phase classification: P2 ➔ P3; N=24 ➔ 39; Initiation date: Feb 2021 ➔ Sep 2021

Clinical • Enrollment change • Phase classification • Trial initiation date • CNS Disorders

Safety, Tolerability, and Efficacy of PLX-200 in Patients With CLN3 (clinicaltrials.gov) - P2; N=24; Not yet recruiting; Sponsor: Polaryx Therapeutics, Inc.

Clinical • New P2 trial • CNS Disorders