Polaryx Therapeutics selected a CRO for its SOTERIA Phase 2 basket trial evaluating PLX-200 in four lysosomal storage disorders. The trial is planned to start in the first half of 2026, following an FDA safe-to-proceed letter received in October 2025.
Polaryx Therapeutics has selected a contract research organization to conduct SOTERIA, a phase 2 trial evaluating PLX-200 across four rare lysosomal storage disorders, with trial initiation planned for the first half of 2026.
Over 100 children with rare diseases in India have exhausted the Rs 50 lakh financial assistance limit under the National Policy for Rare Diseases 2021, forcing treatment halts and prompting urgent appeals for continued support.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07740512 |
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PLX-200 in Pediatric Patients (Master Protocol) |
NOT_YET_RECRUITING | PHASE2 |
| NCT02120235 |
Investigating Lysosomal Storage Diseases in Minority Groups |
UNKNOWN | |
| NCT02000310 |
Molecular and Cellular Mechanisms of Lysosomal Storage Diseases |
UNKNOWN | |
| NCT00654433 |
ALD-101 Adjuvant Therapy of Unrelated Umbilical Cord Blood Transfusion (UCBT) in Patients With Inherited Metabolic Diseases |
TERMINATED | PHASE3 |
| NCT00001215 |
Genetic Studies of Lysosomal Storage Disorders |
ENROLLING_BY_INVITATION |
