Initiating Two Phase 2b Studies in 2015
NEWTON, Mass.--(BUSINESS WIRE)--Allena
Pharmaceuticals, Inc., a specialty biopharmaceutical company focused
on developing and commercializing innovative non-systemic oral protein
therapeutics to treat metabolic and orphan diseases, today announced
positive results from a Phase 2a clinical trial of ALLN-177,
an orally administered recombinant oxalate degrading enzyme being
developed for the chronic management of hyperoxaluria and kidney stones.
The multicenter, open-label study demonstrated a statistically
significant reduction of urinary oxalate excretion in recurrent calcium
oxalate kidney stone patients with hyperoxaluria treated with ALLN-177
relative to baseline (P=0.0084). ALLN-177 was well tolerated and no
serious adverse events were reported.
“We are very pleased with the results of this trial of ALLN-177,
Allena’s first study in patients with recurrent calcium oxalate kidney
stones due to hyperoxaluria”
Hyperoxaluria is excessive urinary excretion of oxalate,
a condition resulting from either hyperabsorption of dietary oxalate or
the overproduction of oxalate in the body due to one of several known
genetic defects. Hyperoxaluria, if left untreated, can lead to kidney
stones, and in more severe cases, can progress to chronic kidney
disease, end-stage renal disease and transplantation.
“We are very pleased with the results of this trial of ALLN-177,
Allena’s first study in patients with recurrent calcium oxalate kidney
stones due to hyperoxaluria,” said Alexey Margolin, Ph.D., co-founder,
president and CEO of Allena Pharmaceuticals. “Based on these positive
Phase 2a results, we are initiating two randomized, placebo-controlled
studies in patients with enteric and idiopathic hyperoxaluria, which we
expect to start later this year.”
“Sustained high levels of hyperoxaluria can lead to serious related
conditions, including kidney stones and chronic kidney disease, and with
time to oxalate nephropathy and kidney failure,” said David S. Goldfarb,
M.D., professor of medicine & physiology at NYU Langone Medical Center
and chief of nephrology at NY Harbor VA Medical Center. “Once a patient
with hyperoxaluria has been diagnosed, intervention is required to
prevent the development of these serious complications. Presently, there
are no effective oxalate-reducing therapies available – significantly
limiting therapeutic options for many patients in need. The results of
this clinical trial are very encouraging, and ALLN-177 could represent a
significant breakthrough for these patients if confirmed in further
trials.”
About the Study
The multicenter, open-label, single-arm outpatient Phase 2a study
evaluated the safety and efficacy of ALLN-177 in recurrent calcium
oxalate kidney stone patients with hyperoxaluria. Patients (n=16) were
on self-selected diets (typically low oxalate) as well as high calcium
and high liquid intake, as well as their standard medications (potassium
citrate, thiazides, calcium supplements) throughout the study period.
Key findings included:
The mean reduction of urinary oxalate excretion (UOx)/24-hours between
baseline and treatment periods was 13.9±18.4 mg. The overall reduction
was highly statistically significant (p = 0.0084);
Eleven of 16 subjects had a mean UOx reduction of >5 mg/24 hours on
ALLN-177 (range: 5-60.8 mg; mean 20.8 mg);
30% of patients in this study exhibited extremely high urinary oxalate
levels at baseline (>80 mg range: 87-231 mg UOx/24-hours). Typically
these levels are consistent with patients who have known genetic
defects (primary hyperoxaluria); and
ALLN-177 was well tolerated and no significant adverse events were
reported.
About Hyperoxaluria and Kidney StonesHyperoxaluria is a condition resulting from high oxalate levels in the
urine due to either hyper- absorption of oxalate from the diet
(secondary) or from overproduction of oxalate by the liver (primary) due
to a genetic defect. Hyperoxaluria can initially cause the development
of kidney stones or can lead to kidney damage (nephrocalcinosis),
chronic kidney disease, end-stage renal disease and dialysis. There are
currently no effective pharmacologic treatments for hyperoxaluria.
The incidence of kidney stones has increased dramatically in the last 10
to 20 years, affecting one in 11 people in the U.S. in 2010, compared to
one in 20 in 1994. An estimated four million people in the U.S. suffer
from a kidney stone annually, and 25 percent of these are frequent or
intermittent stone formers. In 2009, there were 1.3 million visits to an
emergency department (ED) in the U.S. for kidney stones, accounting for
approximately 1% of all ED visits. Approximately 20% of all ED visits
for kidney stones resulted in hospitalization.
Kidney stones, while episodic, are also associated with a two-fold
higher risk of chronic kidney disease and end-stage renal disease, as
well as a higher risk of atherosclerosis and cardiovascular events. The
prevalence of kidney stones is greater in patients with intestinal
disease or fat malabsorption who are at higher risk for hyperoxaluria
due to hyper-absorption of oxalate. This high-risk population includes
those who have undergone bowel resection, bariatric or gastric surgery,
and people with fat malabsorption due to conditions like Crohn’s
disease, cystic fibrosis, short bowel syndrome and liver disease.
About ALLN-177ALLN-177 is an orally administered recombinant oxalate degrading enzyme
in development for the chronic management of hyperoxaluria and kidney
stones (nephrolithiasis). ALLN-177 targets oxalate in the
gastrointestinal tract, reducing 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 the incidence of calcium oxalate kidney
stones and related complications. Effective management of hyperoxaluria
could reduce long term kidney complications as well as the number of
interventions required for the management of kidney stones such as
emergency room visits, hospital admissions, extractions and lithotripsy.
About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is a specialty biopharmaceutical company
focused on developing and commercializing non-systemic protein
therapeutics to treat metabolic and orphan diseases. Allena’s lead
program, ALLN-177, is expected to enter a Phase 2b clinical trial in
patients with hyperoxaluria in 2015. The company’s proven approach
enables the design and development of oral protein therapies that remain
in the gastrointestinal (GI) tract, where the protein exerts its
therapeutic effect by reducing toxic metabolites without being absorbed
into the bloodstream. Led by a proven management team with deep
expertise in protein therapeutic design and development, Allena is
committed to bringing breakthrough new treatments to patients with unmet
medical needs. Based in Newton, Mass., the company is backed by top-tier
venture investors including Frazier
Healthcare, Third
Rock Ventures, HBM
Partners, Bessemer Venture Partners and other investors. For more
information, please visit .
Contacts
Company Contact:Allena PharmaceuticalsRobert Gallotto, Chief
Operating Officer617-467-4577orMedia Contact:Pure
CommunicationsKatie Engleman, 910-509-3977
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