Eloxx finalizes Phase 2 kidney disease trial and appoints new chief medical officer
Eloxx Pharmaceuticals finalized the global EXPRESS Phase 2 study of exaluren for nonsense-mutation autosomal dominant polycystic kidney disease on October 20, 2026. The trial is designed to enroll 60 adults for 52 weeks, with first-patient dosing expected in 3Q 2027 and topline data in 1H 2029. Eloxx also appointed T.R. Srinivas, M.D., as Senior Vice President and Chief Medical Officer.
Why it matters
The trial design advances Eloxx's lead clinical program and sets the next development milestones for investors. The FDA said a substantial and durable htTKV effect, supported by eGFR and safety data, could potentially support Breakthrough Therapy Designation, but any designation or accelerated pathway depends on clinical results and further FDA discussions.
Key facts
- 1EXPRESS will randomize approximately 60 adults 1:1 to exaluren or placebo for 52 weeks, using annualized htTKV change as its primary endpoint. prnewswire.com
- 2The FDA identified htTKV change as a potential surrogate endpoint for accelerated approval in ADPKD. prnewswire.com
- 3Exaluren received orphan drug designation for ADPKD in the United States in addition to Europe. prnewswire.com
- 4T.R. Srinivas will lead medical strategy and clinical evidence work across Eloxx's Alport and ADPKD programs. prnewswire.com
Open questions
- The FDA has not granted Breakthrough Therapy Designation or accelerated approval; both remain conditional on future clinical results and FDA discussions.
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.