The following excerpt is from the company's SEC filing.
study focused on high unmet need in patients with gout and chronic kidney
- Novel therapeutic candidate targets uric acid in the GI tract
- Initial data expected in late 2021 or early 2022 -
NEWTON, Mass., September 29, 2021 Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) (Allena or the Company), a late-stage
biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize
oral enzyme therapeutics for
metabolic diseases, today reported that it has dosed the first patient in a se cond Phase 2a trial of
202 Trial), a novel, orally-administered, urate-degrading enzyme in development for the treatment of gout in patients with chronic kidney disease (CKD). The Phase 2a program, comprised of this
outpatient trial and a
inpatient trial currently being conducted in a clinical pharmacology unit, is designed to assess initial bioactivity data and
additional safety data for
the second orally delivered,
enzyme developed using Allenas proprietary oral enzyme technology platform.
We are pleased to initiate our second trial in the Phase 2a program for
noted Louis Brenner,
M.D., President and Chief Executive Officer of Allena. In gout patients with chronic kidney disease, the GI tract becomes the primary route of elimination for uric acid, and
designed to capitalize on this physiologic adaptation by enhancing the breakdown and excretion of uric acid in the GI tract. Currently available agents are either dose-limited or contraindicated in this challenging patient population due to safety
and tolerability concerns. We have been very pleased with the results from the Phase 1 studies, in which
was well-tolerated with no safety signals observed.
Dr. Brenner added, We look forward to reporting initial data from this study, as well as initial data from our ongoing
inpatient study in subjects with hyperuricemia, beginning in late 2021 or early 2022. As we evaluate the initial data from the Phase 2a program, we will potentially study additional patients to assist us
in determining the optimal dosing paradigm and target population for later stage clinical trials.
About the Phase 2a Program for
The Phase 2a trial (Study 202) announced today is an outpatient study expected to enroll 24 hyperuricemic
patients with gout and
chronic kidney disease. Patients are to be randomized (2:1) to receive either five capsules of
or matching placebo, three times daily, during a
treatment period. Of the two
cohorts of 12 patients each, the first cohort will consist of patients with an eGFR (estimated glomerular filtration rate) of
mls/minute, and the
second will consist of patients with an eGFR of
The other Phase 2a trial (Study 201), initiated
in July, is a
study conducted in a clinical pharmacology unit (CPU) setting enrolling patients with hyperuricemia. Patients are randomized (2:1) to receive either
or matching placebo. Dosing of
for the initial cohort of approximately 12 patients is five capsules of
three times daily, with the dose level of
for any additional cohorts to be determined based upon data from the first cohort.
For both studies, key bioactivity endpoints will include measurements of serum uric acid and urine uric acid. Both studies will also assess safety and
tolerability in the hyperuricemia, gout and chronic kidney disease patient populations.
to Address the Underserved Gout Treatment Landscape
In June, the Company hosted a KOL webinar highlighting the treatment paradigms and also
limitations of existing gout therapies with key opinion leader (KOL), Robert Terkeltaub, M.D., Professor of Medicine at the University of California San Diego School of Medicine and Section Chief of Rheumatology at the Veterans
Administration Medical Center in San Diego (a replay of the webinar can be found here). Managing gout in the setting of advanced chronic kidney disease remains a significant challenge for clinicians because currently available agents are
either dose-limited or contraindicated in these patients. There are approximately 500,000 patients with gout and advanced chronic kidney disease in the United States.
is an investigational
orally administered enzyme for the
treatment of hyperuricemia and gout, a metabolic disorder characterized by high systemic levels of uric acid that can lead to several complications, including arthritis, kidney stones, and chronic kidney disease.
Allena recently completed a Phase 1b multiple ascending dose study of
The study included 18 healthy
volunteers, who received either
or placebo (2:1 randomization) for seven days. There were two cohorts consisting of nine subjects each, with the first receiving three capsules of
three times daily, and the second receiving five capsules of
three times daily.
was well tolerated with no
evidence of systemic absorption, as confirmed by an
immunosorbent assay (ELISA). Evaluation of clinical and laboratory parameters revealed no significant safety signals and no serious adverse
events were reported.
About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company leveraging its novel oral biologic platform to discover, develop and commercialize
Allenas 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
for the treatment of hyperuricemia and gout in the setting of advanced
chronic kidney disease, with a Phase 1 multiple ascending dose study recently completed and a Phase 2a program recently initiated.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements concerning the future clinical, regulatory and commercial potential of reloxaliase, statements regarding enrollment and the timing of the planned interim analysis in the
trial, the impact of an earlier initial interim analysis on the size and duration of the
trial, statements regarding Allenas strategy of pursuing
a BLA submission for reloxaliase based upon data from its URIROX program using the accelerated approval regulatory pathway, which strategy is predicated on the FDAs agreement with our predictive model supporting a relationship between UOx
levels and kidney stone formation rates, statements regarding Allenas development of
including the timing of planned clinical trials and the announcement of topline data for these trials, and
statements regarding Allenas financial position and need for capital. Any forward-looking statements in this press release are based on managements 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 Allenas clinical trials of its product candidates; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allenas 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; risks associated with Allenas financial condition and its need
to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and ALLN-346 and its ability to continue as a going concern; risks associated with Allenas dependence on third parties;
and risks related to the
coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allenas actual results to differ from those
contained in the forward-looking statements, see the section entitled Risk Factors in Allenas Quarterly Report
on Form 10-Q for
the quarter ended June 30, 2021, as
well as discussions of potential risks, uncertainties and other important factors in Allenas 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 Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
Berry & Company Public Relations
The above information was disclosed in a filing to the SEC. To see the filing, click here.
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