Eloxx Pharmaceuticals reported additional independent confirmation on the positive TEM assessment results from its proof-of-concept Phase 2 open-label clinical trial of ELX-02 for the treatment of Alport syndrome after eight weeks of treatment. Visual assessment of TEM images from kidney biopsies showed an improvement in foot process effacement in all three treated patients consistent with disease regression. Additional independent confirmation has now been reported. The qualitative assessment of images of pre- and post-treatment kidney biopsies from the three patients in the Phase 2 clinical trial noted: Patient 4401-01 and Patient 4401-02: All images showed more regions of glomerular basement membranes in post-treatment biopsies covered by intact foot processes, consistent with partial improvement of podocyte injury in those biopsies. As previously announced, Patient 4401-02 achieved remission based on Urine-Protein Creatine ratio. Patient 4402-01: Post-treatment images showed wider areas of intact foot processes compared with either pre- or post-treatment images for Patient 4401-01 and Patient 4401-02. These findings are generally consistent with previous assessments, providing stronger evidence of protein restoration and the disease modifying effect of ELX-02 and potential for improvement in proteinuria with longer duration of treatment.
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