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 clinical data from its Phase 1 trial of ALLN-346 in
healthy volunteers. 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 chronic kidney disease (CKD).
The double-blind, placebo-controlled, single-ascending dose
study enrolled 24 healthy volunteers. Groups of eight study
participants were randomized 3:1 to ALLN-346 or matching placebo in
three sequential cohorts dosed orally with three, six, or 12
capsules in one day. Each capsule of ALLN-346 contained a target
dose of 90 mg of enzyme, equivalent to 2,250 units. ALLN-346 was
well-tolerated with no clinically significant safety signals and no
dose-limiting toxicities observed in any cohort up to the highest
administered dose. In addition, assay of serum samples by ELISA
immunoassay demonstrated that ALLN-346 was not absorbed
systemically, supporting that its mechanism of action appears to be
restricted to the GI tract.
“We are very encouraged by the preliminary safety and
tolerability data collected for ALLN-346 in healthy volunteers,”
said Louis Brenner, M.D, President and Chief Executive Officer of
Allena. “While there are several classes of approved therapies to
treat hyperuricemia and gout, all have significant limitations in
the CKD population due to toxicity-related concerns, dose
limitations, and contraindications. We specifically designed
ALLN-346 to overcome these challenges, using our proprietary
platform to create a stable oral enzyme that is intended to act via
the gut-kidney axis, degrading urate in the GI tract and reducing
the systemic and metabolic burden of urate on the kidneys. The
results announced today support our belief in ALLN-346’s
gut-restricted mechanism of action and support its further
development as a scientifically-driven therapeutic candidate for
the approximately 375,000 people living with gout and
moderate-to-severe CKD. We are now preparing to advance ALLN-346
into separate Phase 1b multiple-ascending dose and Phase 2 clinical
studies, and look forward to further progress, including potential
proof-of-concept data, in 2021.”
Subject to feedback from the U.S. Food and Drug Administration,
Allena expects to initiate a Phase 1b multiple-ascending dose trial
in healthy volunteers and a Phase 2 proof-of-concept trial in
patients with hyperuricemia and CKD in the first half of 2021, with
initial data from both studies expected in the second half of
2021.
About HyperuricemiaHyperuricemia, 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.
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
_______________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.
About ALLN-346ALLN-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.
About Allena PharmaceuticalsAllena
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 for the treatment of hyperuricemia in the
setting of gout and advanced chronic kidney disease, with a Phase
1b multiple-ascending dose study and a Phase 2 proof-of-concept
study planned for 2021.
Forward-Looking StatementsThis release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 including, without
limitation, statements regarding the clinical data from Allena’s
Phase 1 trial of ALLN-346; Allena’s future development plans for
ALLN-346; Allena’s pipeline of oral enzyme therapeutic candidates
and Allena’s plans to build a commercial organization.
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 September 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
Media ContactAdam DaleyBerry & Company
Public Relations 212-253-8881adaley@berrypr.com
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