Allena Announces Interim Results from Kidney Disorder Med Study

— Substantial Treatment Effect Observed in Patients with Enteric Hyperoxaluria, Including Robust Reductions in Both Urine and Plasma Oxalate –
— Reloxaliase Well-Tolerated Over 12 Weeks of Dosing —
— Detailed Results to be Presented at OHF International Hyperoxaluria Workshop in June 2019 —

Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced interim data from Study 206, its Phase 2 basket clinical trial of reloxaliase, an orally-administered, recombinant oxalate-degrading enzyme. Study 206 includes adult and pediatric patients suffering from the progression of primary hyperoxaluria (PH) or enteric hyperoxaluria (EH) with advanced chronic kidney disease (CKD), both of which can lead to systemic oxalosis, a potentially life-threating condition. Consistent with Allena’s prior clinical experience, EH patients treated with reloxaliase in Study 206 demonstrated a substantial treatment effect.  This includes EH patients with advanced CKD, a patient population not previously treated with reloxaliase, who showed reductions in urine oxalate (UOx) and plasma oxalate (POx). Allena plans to present detailed results at the OHF International Hyperoxaluria Workshop, June 21-22, 2019 in Boston, MA.

“We are pleased to see a robust response to reloxaliase in EH patients suffering from advanced stages of the disease. We believe this reflects reloxaliase’s activity and novel mechanism of action of degrading oxalate within the GI tract, which is well-targeted to treat excess oxalate absorption driven by an underlying GI disorder. The potential to alleviate the high oxalate burden on these patients is very encouraging,” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “To our knowledge, this is a first demonstration of a specific pharmacologic therapy leading to reduction in plasma oxalate and urinary oxalate levels in patients with EH and decreased kidney function, which represents a significant advancement for the field and especially for patients with systemic oxalosis. These results advance our efforts to develop reloxaliase as a potential first-in-class therapy for patients with enteric hyperoxaluria, and we look forward to additional data from Study 206, as well as topline data from our pivotal Phase 3 URIROX-1 trial, anticipated in the second half of the year.”

https://www.globenewswire.com/news-release/2019/06/04/1863888/0/en/Allena-Pharmaceuticals-Announces-Interim-Results-from-Study-206-of-Reloxaliase-in-High-Risk-Patients-with-Advanced-Oxalate-Disorders.html