Study exploring treatment in patients with CKD, gout completes cohorts A, B enrollment
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Allena Pharmaceuticals Inc. announced its ALLN-346 Phase 2a Study 202 examining ALLN-346 treatment in patients with gout and advanced chronic kidney disease has completed enrollment for cohorts A and B.
The FDA granted fast track designation to ALLN-346, a first-in-class, nonabsorbed, orally administered enzyme for the treatment of hyperuricemia and gout in patients with advanced CKD. ALLN-346 was developed to degrade urate in the gastrointestinal tract and reduce urate levels.
Investigators designed a 2-week, outpatient study in which patients who are hyperuricemic will be randomized two to one to receive five capsules of ALLN-346 or placebo three times daily. Ultimately, the study will include four cohorts with up to 12 patients each. Half of enrollment is complete with cohorts A and B. Cohort A enrolled seven patients with gout and stage 2 CKD, and cohort B enrolled 12 patients with gout and stage 3 CKD.
“We are pleased with the progress of our ALLN-346 Phase 2a program and thank our patients, investigators and business partners for helping us achieve this operational milestone,” David J. Clark, MD, MRCP, chief medical officer of Allena Pharmaceuticals Inc., said in the release. “This is an important step in our efforts to develop a new treatment option for patients with hyperuricemia, gout and advanced CKD. There is an established pathophysiologic adaptation of increased intestinal elimination of uric acid in patients with impaired kidney function, so we believe the ALLN-346 therapeutic strategy of degrading uric acid in the gastrointestinal tract is based on a strong scientific rationale. We have been encouraged by initial data from Study 201, which have provided evidence supporting the gastrointestinal mechanism of action for ALLN-346, including the positive correlation between serum uric acid reduction and the degree of renal impairment. We look forward to reporting additional topline safety and efficacy data from the cohorts thus far enrolled in the ALLN-346 Phase 2a development program later this quarter.”
Allena Pharmaceuticals Inc. intends to release topline safety and efficacy results from cohorts A and B by the end of this quarter. The final two cohorts are planned to complete enrollment by the end of 2022.
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