Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients

Summary

The purpose of this phase III study is to assess the efficacy and safety of YW17 produced by CinnaGen Company compared to Aldurazyme® in mucopolysaccharidosis type I (MPS I) patients. All patients receive Aldurazyme® for 12 weeks, followed by YW17 for another 12 weeks. The primary outcome is the assessment of the maintenance of the mean uGAG levels at the end of each medication administration. The secondary outcomes are the assessment of 6-minute walking test (6MWT), predicted forced vital capacity (FVC), enzyme activity assay, and adverse events (AEs).

Timeline

Start

2022-09-10

Primary completion

2023-08-12

Completion

2023-11-18

Publications

• Rabbani A, Alaei M, Asl SN, Setoodeh A, Shakiba M, Salehpour S, Eshraghi P, Salehpour O, Sabzvari A, Kafi H, Jarollahi A. Efficacy and safety of a biosimilar laronidase versus the reference laronidase in patients with mucopolysaccharidosis type I. Sci Rep. 2025 Aug 19;15(1):30427. doi: 10.1038/s41598-025-16351-4.

Drugs

Indications