Allena Doses First Patients in Mid-Stage Hyperoxaluria Trial

Rare Daily Staff

Allena Pharmaceuticals said it treated the first patients in a mid-stage study of ALLN-177, its experimental, first-in-class oral enzyme therapy for treatment of hyperoxaluria, a rare and potentially fatal kidney disorder.

Hyperoxaluria is characterized by extremely high levels of oxalate, a metabolite that is normally excreted from the body, but in excess can cause kidney stones and severe kidney damage, which may require that patients receive a kidney transplant.

ALLN-177 is designed to degrade oxalate in the GI tract before it can cause damage to the kidneys. ALLN-177 is a recombinant oxalate-degrading enzyme that 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.

The open-label Phase 2 clinical trial will include 15-20 adults and adolescents with both primary hyperoxaluria, caused by a genetic defect that leads to overproduction of oxalate by the liver, and enteric hyperoxaluria, which is caused by certain GI conditions that lead to over absorption of oxalate from diet.

The endpoints for the study are change from baseline in 24-hour urinary oxalate excretion and plasma oxalate levels. Patients with kidney failure or on dialysis may comprise up to 25 percent of total enrollment. U.S. clinical trial sites are enrolling patients, and investigators are preparing to enroll patients at European sites in the third quarter of 2018.

“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 Alexey Margolin, CEO of Allena Pharmaceuticals. “In the long-term, reducing urine and plasma oxalate levels in these patients can diminish the amount of systemic oxalate available for crystal formation and deposition in the kidney and in other organs or tissues.”

ALLN-177 has been granted Orphan Drug designations by the U.S. Food and Drug Administration for the treatment of primary hyperoxaluria and for the treatment of pediatric hyperoxaluria. In addition, the European Commission has granted Orphan Drug designation for ALLN-177 for the treatment of primary hyperoxaluria.

Allena is also evaluating ALLN-177 in an ongoing late-stage clinical trial in patients with enteric hyperoxaluria who have normal kidney function or mild to moderate chronic kidney disease.

July 23, 2018
Photo: Alexey Margolin, CEO of Allena Pharmaceuticals