Allena Pharmaceuticals, Inc. (NASDAQ:ALNA), a late-stage,
biopharmaceutical company dedicated to developing and
commercializing first-in-class, oral enzyme therapeutics to treat
patients with rare and severe metabolic and kidney disorders, today
announced that the first subject has been dosed in a Phase 1
clinical trial of ALLN-346. ALLN-346 is an investigational, orally
administered, novel urate-degrading enzyme that has been designed
for activity and stability in the gastrointestinal (GI) tract, and
is intended for the treatment of hyperuricemia in patients with
gout and advanced chronic kidney disease (CKD).
Hyperuricemia, or elevated levels of uric acid in the blood, is
due to overproduction and/or insufficient excretion of uric acid
and is a significant predisposing condition for gout. Increased
uric acid excretion in the urine and hyperuricemia are also
associated with kidney stone formation and kidney damage. CKD
patients with hyperuricemia and gout are often not optimally
managed due to limitations of available therapies, including
decreased tolerability, dose restrictions, drug-drug interactions,
and contraindications. According to a published study, there are
approximately 375,000 patients in the United States with
hyperuricemia and CKD on urate lowering therapy who have
uncontrolled gout.1
“We are thrilled to advance ALLN-346, our second product
candidate, into the clinic. Like reloxaliase, ALLN-346 was designed
using our proprietary oral enzyme technology platform. Our goal is
to create the first orally-delivered, non-absorbed, stable enzyme
that degrades urate in the GI tract, in order to reduce the
metabolic burden of urate on the kidney,” said Louis Brenner, M.D.,
President and Chief Executive Officer of Allena Pharmaceuticals.
“This is another compelling application of our oral enzyme
platform, as our scientific team continues to innovate and provide
potential new treatments for patients with difficult metabolic
diseases.”
This Phase 1 clinical trial is a randomized, double blind,
placebo-controlled, single ascending dose study of orally
administered ALLN-346 in approximately 24 healthy volunteers. The
primary objective of the study is to assess safety and tolerability
over 28 days. Allena expects to report initial clinical data in the
fourth quarter of 2020, subject to the impact of COVID-19. For more
information about the clinical trial design, please visit:
www.clinicaltrials.gov (NCT04236219).
At the 2018 American College of Rheumatology (ACR/ARHP) Annual
Meeting, Allena presented preclinical proof-of-concept data for
ALLN-346, demonstrating urate reduction in a urate oxidase
knock-out mouse model, an animal model of severe hyperuricemia with
kidney damage due to urate crystal deposition. After one week of
treatment, mice treated with ALLN-346 achieved a substantial
reduction in urate burden on the kidney, as evidenced by
normalization in urine uric acid and a significant reduction in
plasma urate. These data were subsequently supported in a porcine
model with acutely induced hyperuricemia that was presented at the
ACR/ARHP Annual Meeting in 2019.
“Patients with gout and moderate-to-severe CKD are in need of
new therapeutic options, which can help lower the levels of uric
acid in their blood and urine and help limit painful flares of
gouty arthritis and potentially limit kidney stones. The oral
therapies available to treat hyperuricemia in gout patients all are
limited by CKD in their dosing and efficacy, and boosting
convenient oral uric acid lowering therapies with this approach is
compelling,” said Robert Terkeltaub, M.D., Professor of Medicine
at University of California San Diego. “By leveraging the
gut-kidney-axis, ALLN-346 relies on a novel mechanism of action,
which corresponds to the underlying physiology of hyperuricemia and
the extrarenal pathway for uric acid elimination. There is
potential for improved reduction in uric acid burden in gout
patients with moderate-to-severe CKD.”
About Hyperuricemia
Hyperuricemia, or elevated levels of uric acid in the blood,
results from overproduction or insufficient excretion of urate, or
often a combination of the two. Hyperuricemia is associated with
gout, a kind of arthritis caused by excess uric acid in the blood
that leads to the formation of hard crystals in the joints.
Hyperuricemia can also lead to increased uric acid excretion in the
urine and subsequently to kidney stone formation and kidney damage
also known as urate nephropathy. In addition, hyperuricemia has
been linked to hypertension, CKD, glucose intolerance,
dyslipidemia, insulin resistance and obesity.
About ALLN-346
ALLN-346 is an investigational, orally administered, novel,
engineered urate oxidase that has been optimized for stability in
the GI tract and high production yield. Allena has designed
ALLN-346 to degrade urate in the GI tract and in turn, reduce the
urate burden on the kidney and lower the risk of urate-related
complications. ALLN-346 is targeted to lower serum uric acid in
patients with CKD, whose renal function is decreased and who have
diminished capacity for urinary excretion of uric acid. In
September 2020, Allena announced first enrollment in a Phase 1
clinical trial of ALLN-346 and expects to report initial clinical
data in the fourth quarter of 2020.
About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is a late-stage
biopharmaceutical company dedicated to developing and
commercializing first-in-class, oral enzyme therapeutics to treat
patients with rare and severe metabolic and kidney disorders.
Allena’s lead product candidate, reloxaliase, is currently being
evaluated in a pivotal Phase 3 clinical program for the treatment
of enteric hyperoxaluria, a metabolic disorder characterized by
markedly elevated urinary oxalate levels and commonly associated
with kidney stones, chronic kidney disease and other serious kidney
disorders. Allena is also developing ALLN-346, currently being
evaluated in a Phase 1 clinical trial, for the treatment of
hyperuricemia in the setting of gout and advanced chronic kidney
disease.
Forward-Looking Statements
This release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements regarding the Allena’s
development of ALLN-346 and the Phase 1 clinical trial, statements
regarding implementation of the amended trial design
for URIROX-2 , the timing of sample size reassessments
and interim analyses during the URIROX-2 trial, Allena’s
ability to utilize the accelerated approval regulatory pathway for
reloxaliase, the impact of the COVID-19 coronavirus on
Allena’s business, the biotech sector generally and the broader
macroeconomic environment, statements concerning the future
clinical, regulatory and commercial potential of reloxaliase
statements regarding Allena’s financial position and need for
capital. Any forward-looking statements in this press
release are based on management’s current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking
statements. These risks and uncertainties include, but are not
limited to: market and other conditions, the timing for completion
of Allena’s clinical trials of its product candidates, risks
associated with obtaining, maintaining and protecting intellectual
property; risks associated with Allena’s ability to enforce its
patents against infringers and defend its patent portfolio against
challenges from third parties; the risk of competition from other
companies developing products for similar uses; risk associated
with Allena’s financial condition and its need to obtain additional
funding to support its business activities, including the future
clinical development of reloxaliase and its ability to continue as
a going concern; risks associated with Allena’s dependence on third
parties; and risks related to the COVID-19 coronavirus. For a
discussion of other risks and uncertainties, and other important
factors, any of which could cause Allena’s actual results to differ
from those contained in the forward-looking statements, see
the section entitled “Risk Factors” in Item 1A of Part I of
Allena’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020, as well as discussions of
potential risks, uncertainties and other important factors in
Allena’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Allena undertakes no duty to update this
information unless required by law.
Investor ContactHannah DeresiewiczStern
Investor Relations,
Inc.212-362-1200hannah.deresiewicz@sternir.com
1 Lim, J., Fu, A., Reasner, D. & Taylor, D. (2017,
April). Prevalence of CKD and Uncontrolled Gout Among US
Adults: Results From NHANES 2007–2012. Poster presented at the
National Kidney Foundation Spring Clinical Meetings, Orlando,
FL.
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