Allena Pharmaceuticals Provides Updates on Reloxaliase Development Program and Corporate Activities
December 04 2019 - 5:00PM
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 updates on its clinical development programs for
reloxaliase, a potential first-in-class, non-absorbed, orally
administered enzyme for the treatment of severe hyperoxaluria, and
several initiatives to realign resources to support the continued
development of reloxaliase for patients with enteric hyperoxaluria
(EH).
Following positive topline results from URIROX-1 and further
analysis of the data from the trial, Allena plans to re-engage with
the FDA, with the request to discuss measures to potentially
streamline its ongoing URIROX program through modifications to the
adaptive URIROX-2 trial design. These enhancements could
potentially include reducing the target enrollment in URIROX-2,
conducting an earlier interim analysis of the data from URIROX-2,
and modifying the requirements for filing for accelerated approval
of the initial reloxaliase Biologics Licensing Application (BLA).
The company expects to meet with the FDA in early 2020 and to
provide an update on the final design and timing of the URIROX-2
study as it evolves.
“We continue to be encouraged by the pivotal Phase 3 URIROX-1
results and are committed to advancing reloxaliase as the first
potential approved treatment for patients with EH,” said Louis
Brenner, M.D., President and Chief Executive Officer of Allena
Pharmaceuticals. “Reloxaliase achieved its primary endpoint in
URIROX-1, demonstrating a statistically significant and clinically
meaningful reduction in urinary oxalate (UOx). Based on the
positive feedback that we continue to receive from key opinion
leaders and clinicians and the severity of the condition in our
trial population, we are confident that reloxaliase has the
potential to alter the treatment landscape for patients with EH,
and offer treating physicians an important new tool for combating
the toxic accumulation of excess oxalate in patients with
gastrointestinal (GI) disorders. We look forward to initiating
discussions with the FDA in the near-term, as we consider
opportunities to streamline the URIROX-2 program and expeditiously
deliver reloxaliase to patients.”
Allena is implementing several measures in order to preserve
capital and focus its resources on its reloxaliase programs, while
maintaining key product development and corporate capabilities:
- The company will limit the opening of new trial sites for its
ongoing URIROX-2 trial and continue to enroll patients at existing
sites, until further clarity from the FDA is received regarding
potential changes to the URIROX program.
- The company will delay additional planned investments in
manufacturing.
- The company will implement a reduction in its workforce that
will lead to an approximately 30 percent reduction in salary and
related compensation expenses.
Allena also remains focused on completing its ongoing Study 206
in patients with EH and advanced chronic kidney disease (CKD).
Based on the results of the study and the severity of the
condition, the company plans to interact with regulatory agencies
in the first quarter of 2020 to discuss the registrational path,
including expedited options, for reloxaliase in high-risk EH
patients with CKD. Additionally, Allena remains on track to file an
investigational new drug (IND) application for ALLN-346, a novel
urate-degrading enzyme, this quarter, though first-in-human studies
will be pursued only once additional financial resources are
secured.
With these measures in place, Allena expects that its current
cash and cash equivalents will be sufficient to fund its operating
expenses and capital expenditure requirements into the fourth
quarter of 2020. The company also continues to explore a
range of potential financial alternatives to support the
development of reloxaliase, including potential financing
transactions and business development partnerships.
Dr. Brenner added: “We remain conscious of the additional
resources we need to advance reloxaliase through our URIROX
program. To that end, we have made the difficult decision to
realign our investments and internal resources to provide us with
resources to enable us to focus on, and execute against, our
strategy of delivering reloxaliase for the treatment of patients
across the spectrum of EH. Unfortunately, this will impact a number
of our highly talented and dedicated employees. We are incredibly
grateful to those who are affected by this decision, and deeply
appreciative of all of their hard work to support our development
of novel therapies for patients with rare and severe metabolic
disorders.”
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 topline data from the URIROX-1
clinical trial, Allena’s ongoing review of these data and
implications for the future clinical, regulatory and commercial
potential of reloxaliase, statements regarding plans to reengage
with the FDA, statements regarding future plans for the URIROX-2
clinical trial, statements regarding Allena’s development of
ALLN-346, including the expected timing of its IND filing, and
statements concerning Allena’s cash position, potential cost
savings, the sufficiency of cash to fund operations and ability to
complete a financing transaction and/or business development
partnership. In addition, it should be noted that additional
capital will be required to fund operations, including completion
of the planned URIROX-2 clinical trial, which capital may not be
available to Allena on terms that are acceptable to it, if at all.
If adequate funds are not available on a timely basis, Allena may
be required to amend, delay, limit, reduce or terminate one or more
of its ongoing or planned clinical trials of its product
candidates. 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: the risk that
Allena’s clinical and regulatory strategy for reloxaliase may
evolve following further review of the topline data from the
URIROX-1 clinical trial and Study 206, including without
limitation, modifications or termination of the planned URIROX-2
clinical trial; the risk that the results of the URIROX-1 clinical
trial may not be replicated in the URIROX-2 or other clinical
trials of reloxaliase; the risk that the reduction in 24-hour UOx
excretion observed in the placebo arm of the URIROX-1 trial may be
observed in the URIROX-2 or other clinical trials of reloxaliase,
which may have a negative impact on Allena’s ability to secure
regulatory approval for this product candidate; the risk that
results of earlier studies, or interim results, may not be
predictive of future clinical trial results, and planned and
ongoing studies may not establish an adequate safety or efficacy
profile for reloxaliase to support regulatory approval or the use
of the accelerated approval regulatory pathway; risks related to
Allena’s ability to utilize the accelerated approval pathway for
reloxaliase, including the risk that available data at the time of
any sample size re-estimation or interim analysis conducted during
the URIROX-2 trial may not be sufficient to demonstrate an
increased probability of kidney stone events in patients with
enteric hyperoxaluria and increasing UOx levels; the risk that the
FDA may require that Allena increase the sample size or duration of
treatment following the sample size reassessments to be conducted
in accordance with the adaptive design element of the trial or
otherwise collect additional clinical data from the URIROX-2 or
other clinical trials prior to submitting a BLA for reloxaliase;
risks associated with Allena’s ability to enroll a sufficient
number of patients to adequately power URIROX-2 in order to achieve
ultimate statistical success for kidney stone disease progression
in the long-term follow-up phase of the trial; risks related to
Allena’s use of UOx and/or POx as surrogate endpoints in its
ongoing clinical trials, neither of which it believes have been
previously utilized as biomarkers to support regulatory approval of
other drug candidates, and the risks related to validating that
reductions in UOx and/or POx correlate with meaningful clinical
benefit; 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 risks associated with Allena’s dependence on third
parties. 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 II of Allena’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2019, 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.
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 a first-in-class, oral enzyme therapeutic for the
treatment of 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.
Investor Contact Hannah Deresiewicz Stern
Investor Relations, Inc.
212-362-1200hannah.deresiewicz@sternir.com
Media Contact Adam Daley Berry & Company
Public Relations 212-253-8881adaley@berrypr.com
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