Eloxx Pharmaceuticals provides ELX-02, ZKN-013 program updates

Eloxx Pharmaceuticals provided program updates for ELX-02 and ZKN-013, including Orphan Drug Designation for ELX-02. ELX-02: Regulatory and Clinical Updates for Alport Syndrome Nonsense Mutation Program: ELX-02 Granted ODD from U.S. FDA: In April, the FDA Office of Orphan Products Development granted ODD for ELX-02 for the treatment of Alport Syndrome. Requested a Pre-Investigational New Drug meeting with U.S. FDA: The request for a pre-IND meeting formally initiates communications with the FDA regarding development of ELX-02 for the treatment of NMAS. Presented Clinical Data Updates at Alport Workshop Meeting in March: Prof. Daniel Gale presented updated results from the Proof-of Concept Study in 3 NMAS patients treated with ELX-02. Meaningful reduction in Podocyte Foot Process Effacement after treatment measured as an average 60% increase in Filtration Slit Density in post treatment kidney biopsies in all 3 patients. Results confirm the expression of functional collagen 4 protein in-line with the mechanism of protein induction of ELX-02. ZKN-013: Update on Global Licensing Partnership with Almirall: In March 2024, Eloxx announced an exclusive license agreement with Almirall to develop and commercialize ZKN-013 in orphan indications including RDEB and FAP with nonsense mutations. Received $3 million in upfront payment. Additional payments of ELX-02 of up to $470 million and tiered royalties on global sales: Eloxx shall be eligible for additional payments throughout the potential development phases, including regulatory and sales milestones of up to $470 million as well as tiered royalties on any potential global sales. Initiated Phase 1 Single Ascending Dose study: Initiated Phase 1 SAD study in Australia with initial results expected in 2nd half of 2024