'At Allena, we are committed to providing a first-in-class treatment for the full spectrum of patients with enteric hyperoxaluria
(EH),' said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals.
"At Allena, we are committed to providing a first-in-class treatment for the full spectrum of patients with enteric hyperoxaluria
," said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals.
However, even in conditions involving fat malabsorption or inflammatory bowel disease (enteric hyperoxaluria
), if probiotics are taken daily for 2 months, the saturation of the urine is reduced to such an extent that approximately 25% less calcium related (oxalate) stones are formed.
The proposed pathophysiology of the acute kidney injury is acute oxalate nephropathy due to enteric hyperoxaluria
, as the unabsorbed fat in the small bowel produces calcium soaps.
Hyperoxaluria is the most frequent metabolic abnormality found in calcium oxalate stone formers and its basis can be idiopathic (most common), secondary (e.g., enteric hyperoxaluria
due to intestinal dysfunction or resection), or due to primary hyperoxaluria (PH) .
Oxalate nephropathy is seen in a variety of clinical settings and may result from enteric hyperoxaluria
, toxic exposures, excessive dietary intake of oxalate, and inborn errors of metabolism.
This disorder is distinct from enteric hyperoxaluria
, which results from hyperabsorption of oxalate from the digestive tract .
Allena Pharmaceuticals announced that it will present on its reloxaliase development program and the unmet need in patients with enteric hyperoxaluria
in four sessions at the Oxalosis & Hyperoxaluria Foundation International Hyperoxaluria Workshop.
Study 206 includes adult and pediatric patients suffering from the progression of primary hyperoxaluria or enteric hyperoxaluria
with advanced chronic kidney disease, both of which can lead to systemic oxalosis, a potentially life-threating condition.
Allena Pharmaceuticals announced an agreement with the Duke Clinical Research Institute, or DCRI, an academic research institute within Duke University School of Medicine, to support the URIROX-2 Phase 3 clinical trial of reloxaliase in enteric hyperoxaluria
. DCRI will establish and lead an academic coordinating center, or ACC, for Allena's URIROX-2, one of two ongoing pivotal Phase 3 clinical trials evaluating the safety and efficacy of reloxaliase as a novel therapy for patients with enteric hyperoxaluria
Allena Pharmaceuticals announced that it has reached alignment with the FDA on both the design of URIROX-2, its second pivotal Phase 3 trial of reloxaliase in patients with enteric hyperoxaluria
and its strategy to pursue a biologics license application, or BLA, submission for reloxaliase using the accelerated approval regulatory pathway.
Allena Pharmaceuticals announced that it will present clinical data characterizing the significant unmet need in patients with enteric hyperoxaluria
in a poster presentation at ASN Kidney Week 2018, held October 23-27, 2018 in San Diego, CA.