First-in-Class Treatment for Enteric Hyperoxaluria

Allena’s lead product candidate, reloxaliase (formerly ALLN-177), is a first-in-class, non-absorbed, orally-administered enzyme for the treatment of hyperoxaluria. Reloxaliase, a crystalline formulation of the enzyme oxalate decarboxylase, has been designed to specifically degrade oxalate within the GI tract, thus limiting systemic absorption of oxalate into the bloodstream. The decrease in systemic absorption reduces the burden on the kidney to filter and then excrete oxalate in the urine and, in turn, reduces the risk of kidney stones and other serious kidney diseases.

Allena has conducted a robust clinical development program of reloxaliase in healthy volunteers and patients with secondary hyperoxaluria. As a result, the company has developed key insights into hyperoxaluria, clinical trials in patients with hyperoxaluria and the activity and tolerability of reloxaliase in this patient population.  In the aggregate, the clinical development program to date has demonstrated that:

•   Reloxaliase can substantially reduce urinary oxalate excretion in patients with enteric hyperoxaluria;

•   Reloxaliase has been well-tolerated, with no drug-related serious or severe adverse events; and

•   Reloxaliase’s effect is specific to oxalate, with minimal to no changes in non-oxalate urine parameters.

Based on these data, the high unmet medical need, and the enzyme’s specific mechanism of action, Allena is initially developing reloxaliase for adult patients with enteric hyperoxaluria.  Enteric hyperoxaluria results from a chronic and unremediable underlying GI disorder associated with malabsorption, such as bariatric surgery complications or Crohn’s disease, which predisposes patients to excess oxalate absorption.  Enteric hyperoxaluria is the more severe type of secondary hyperoxaluria.

Patients with primary or severe secondary hyperoxaluria and declining kidney function, are at risk for systemic oxalosis, which refers to the presence of excess oxalate throughout the body, including the blood, bones, joints, eyes and heart.  We believe that the ability of reloxaliase to degrade oxalate in the GI tract to prevent systemic oxalate absorption and therefore decrease the renal oxalate burden is well suited for testing in these patient populations. If reloxaliase can reduce urine and plasma oxalate levels in these patients, it may be able to diminish the amount of systemic oxalate available for calcium oxalate crystal formation and deposition in the kidney and other organs or tissues.

The FDA has also granted separate orphan drug designations to reloxaliase for the treatment of primary hyperoxaluria and for the treatment of pediatric hyperoxaluria. In addition, the European Commission has granted orphan designation for reloxaliase for the treatment of primary hyperoxaluria. In light of these designations and the high unmet need, the company is enrolling adolescent and adult patients a Phase 2 clinical trial in primary hyperoxaluria or severe forms of secondary hyperoxaluria, both of which can lead to systemic oxalosis, a potentially fatal disorder.

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