Eloxx Pharmaceuticals Finalizes 52-Week Phase 2 EXPRESS Study Design in Nonsense-Mutation ADPKD and Appoints T.R. Srinivas, M.D., Chief Medical Officer
Eloxx finalized the design of its EXPRESS Phase 2 study of exaluren in nonsense-mutation ADPKD: 60 patients randomized 1:1 to exaluren or placebo for 52 weeks, with annualized htTKV growth as the primary endpoint. FDA written feedback indicated a substantial, durable htTKV effect could support Breakthrough Therapy Designation, and htTKV change is listed as a potential surrogate endpoint for accelerated approval. Exaluren also received US orphan drug designation for ADPKD; first patient dosing is expected 3Q 2027 with topline data in 1H 2029. The company appointed T.R.
Key figures
- Drug Name
- exaluren
- Phase Of Trial
- Phase 2
- Study name
- EXPRESS
- Topline data
- 1H 2029
- Randomization
- 1:1 exaluren vs placebo
- Primary endpoint
- annualized rate of change in height-adjusted total kidney volume (htTKV)
- Adpkd us patients
- 160,000 to 200,000
- Patients enrolled
- 60
- First patient dosing
- 3Q 2027
- Nonsense mutation share
- 26% of PKD1 and PKD2 mutations
- Treatment duration weeks
- 52
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