Allena Pharmaceuticals Announces First Patients Treated in Phase 2 Basket Study of ALLN-177 in Patients with Primary Hyperoxaluria or Enteric Hyperoxaluria and Advanced Chronic Kidney Disease
Severe hyperoxaluria can result from genetic causes that lead to the overproduction of oxalate by the liver (primary hyperoxaluria) or certain GI conditions that lead to the over absorption of oxalate from diet (enteric hyperoxaluria). Patients with severe hyperoxaluria are at an increased risk of developing systemic oxalosis, a potentially fatal condition that results in oxalate crystal formation throughout the body including in the blood, kidney, bones, joints, skin, eyes and heart. In patients with enteric hyperoxaluria and systemic oxalosis, high plasma oxalate levels can also lead to kidney damage and accelerated decline in renal function.
“In enteric hyperoxaluria patients with kidney impairment, oxalate can form crystals in the kidney tissue, which can cause inflammation, fibrosis and progressive renal failure. As kidney function declines, patients have diminished capacity to excrete oxalate from the body, further perpetuating an increase in systemic oxalate levels and oxalate crystallization,” said
Study 206 is a multi-center, open-label, single arm study that will enroll between 15 and 20 patients in the U.S. and
“ALLN-177 was designed to degrade oxalate in the GI tract. As a result, we believe ALLN-177 has the potential to reduce systemic oxalate absorption and decrease the renal oxalate burden in patients with severe hyperoxaluria and systemic manifestations of the disease,” said
Allena is also evaluating ALLN-177 in URIROX-1™, an ongoing Phase 3 clinical trial in patients with enteric hyperoxaluria who have normal kidney function or mild to moderate CKD. ALLN-177 has been granted separate orphan drug designations by the
About Hyperoxaluria and Systemic Oxalosis
Hyperoxaluria is a metabolic disorder characterized by elevated urinary oxalate levels that may be due to either overproduction of oxalate by the liver from a genetic defect, known as primary hyperoxaluria, or from the excess absorption of oxalate from the diet, known as secondary hyperoxaluria. Secondary hyperoxaluria is further characterized either as enteric, resulting from a chronic and unremediable underlying gastrointestinal disorder, or idiopathic, meaning the underlying cause is unknown. Systemic oxalosis occurs when excess oxalate is present throughout the body including the blood, kidney, bones, joints, eyes and heart. People living with systemic oxalosis have varying degrees of renal impairment including kidney stones, nephrocalcinosis, chronic kidney disease, and end-stage renal disease. For more information about the disorder and videos featuring patient stories, visit http://www.allenapharma.com/systemic-oxalosis.
ALLN-177 is an orally-administered, recombinant oxalate-degrading enzyme that is being developed for the treatment of severe hyperoxaluria. ALLN-177 is being developed to target oxalate in the GI tract in an effort to reduce the burden of both dietary and endogenously-produced oxalate. ALLN-177 has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce long-term kidney complications. ALLN-177 has been granted separate orphan drug designations by the
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, see the section entitled “Risk Factors” in Allena’s Quarterly Report on Form 10-Q for the quarter ended
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Source: Allena Pharmaceuticals, Inc.