Eloxx Pharmaceuticals Finalizes 52-Week Phase 2 EXPRESS Study Design in Nonsense-Mutation ADPKD and Appoints T.R. Srinivas, M.D., Chief Medical Officer
Key Highlights
- ➤EXPRESS plans 60 patients randomized 1:1 to exaluren or placebo for 52 weeks
- ➤Annualized htTKV growth is EXPRESS's primary endpoint, measured by MRI
- ➤First patient dosing expected in 3Q 2027; topline data expected in 1H 2029
- ➤FDA says substantial, durable htTKV effects could support Breakthrough Therapy Designation
- ➤Eloxx received U.S. orphan drug designation for exaluren in ADPKD
Expert Statements
Sumit Aggarwal, President and Chief Executive Officer of Eloxx
“We have deliberately designed EXPRESS as a 52-week study to generate a more robust assessment of htTKV growth change and a full year of kidney-function and safety data. We believe this trial design brings considerable potential regulatory and value creation opportunities”
Sumit Aggarwal, President and Chief Executive Officer of Eloxx
“We have also strengthened our clinical team, including the appointment of Dr. T.R. Srinivas as Chief Medical Officer, to advance our rare kidney programs and support the EXPRESS and EXACT clinical studies.”
T.R. Srinivas, Senior Vice President and Chief Medical Officer of Eloxx
“People with ADPKD caused by a nonsense mutation tend to reach kidney failure earlier, and no available therapy addresses the genetic mutation driving their disease.”
T.R. Srinivas, Senior Vice President and Chief Medical Officer of Eloxx
“Exaluren is designed to restore the missing protein itself, which is a fundamentally different approach. I am excited to join Eloxx at this stage and to help bring this novel potential therapy to patients.”
Eloxx Pharmaceuticals Finalizes 52-Week Phase 2 EXPRESS Study Design in Nonsense-Mutation ADPKD and Appoints T.R. Srinivas, M.D., Chief Medical Officer PR Newswire
* EXPRESS Phase 2 design finalized: 52 weeks of dosing of approximately 60 patients randomized 1:1 to exaluren or placebo, with annualized htTKV growth as the primary endpoint * Substantial, durable htTKV effect could support Breakthrough Therapy Designation; FDA also lists htTKV as a potential surrogate endpoint for accelerated approval in ADPKD * First patient dosing expected in 3Q 2027, and 52-week topline data expected in 1H 2029 * Orphan drug designation granted for ADPKD in the US in addition to Europe * T.R. Srinivas, M.D., joins from Novartis as Senior Vice President and Chief Medical Officer, strengthening medical leadership across Eloxx's ADPKD and Alport programs * Peer-reviewed preclinical data show exaluren restores full-length polycystin-1 in cells carrying PKD1 nonsense mutations and partially corrects disease-associated signaling pathways ARLINGTON, Mass., Oct. 20, 2026 /PRNewswire/ -- Eloxx Pharmaceuticals, Inc. (Nasdaq: ELOX), a clinical-stage biopharmaceutical company developing exaluren for the treatment of rare kidney diseases, today announced the finalized design of its EXPRESS Phase 2 global study in nonsense-mutation autosomal dominant polycystic kidney disease (ADPKD) and the appointment of T.R. Srinivas, M.D., as Senior Vice President and Chief Medical Officer.
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