Sepul Bio (Théa) Launches Phase 2b Clinical Trial of Ultevursen

FIRST PATIENT WITH USH2A-ASSOCIATED RETINITIS PIGMENTOSA TREATED 

 

Sepul Bio has announced that the first participant has been dosed in the LUNA study, a Phase 2b clinical trial investigating ultevursen for individuals with retinitis pigmentosa (RP) or non-syndromic RP caused by variants in exon 13 of the Usher Syndrome Type 2a gene. 

LUNA
LUNA, or SB-421a-006, is a two-year, double-masked study of ultevursen. The trial will enroll 81 adults and children (aged eight and older) with retinitis pigmentosa caused by variants in exon 13 of the *USH2A* gene. The first clinical site has started in the United States, and the Sepul Bio team will open additional locations around the world in the coming months.

Stichting Ushersyndroom is collaborating closely with the Sepul Bio team to bring clinical trial centers to the Netherlands. It is expected that Phase 2b of the clinical trial will take place in Amsterdam, Rotterdam, and Nijmegen. Further information about the opening of these Dutch clinical sites will be announced soon (early 2025) by Sepul Bio.

Sepul Bio
The Sepul Bio team was established in December 2023 and has worked diligently to restart the ultevursen program following its transition from ProQR to Théa. The team’s mission is to advance ultevursen as a treatment option and bring this promising new therapy as quickly as possible to patients with USH2A-associated retinitis pigmentosa.

For more information about Sepul Bio, visit the Sepul Bio website.
Read Sepul Bio’s press release here. 

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