Item 8.01. Other Events.
On
ALLN-346 Program Update
ALLN-346 is a potential first-in-class, non-absorbed, orally administered enzyme
in development for the treatment of hyperuricemia and gout in the setting of
advanced chronic kidney disease (CKD). In
The ALLN-346 Phase 2a clinical program consists of two trials: Study 201, a
one-week inpatient study conducted at a clinical pharmacology unit, and Study
202, a two-week outpatient study being conducted at 23 sites across the
For Study 201, patients with hyperuricemia were randomized (2:1) to receive
either five capsules of ALLN-346 or matching placebo three times daily for one
week. The trial enrolled 16 patients (11 in cohort A and 5 in cohort B), the
majority of whom had stage 2 CKD. Preliminary, topline data from the cohort A
patients were reported in
As announced in January, data from the first group of patients (cohort A) demonstrated a statistically significant reduction in serum uric acid (sUA) from baseline (p<0.05) in patients treated with ALLN-346 compared to placebo. The results from the additional five patients (cohort B) were consistent with those seen in the first 11 patients. In the full group of 16 patients, statistically significant reductions in sUA were seen from days five to seven (p<0.01 on days five and six, and p<0.05 on day seven). There was approximately a 15% reduction from baseline seen in sUA in patients treated with ALLN-346 vs. an approximately 8% reduction from baseline seen in the placebo group. The results also provide support for the potential GI-based mechanism of action of ALLN-346. Specifically, there was a positive correlation between the effect of ALLN-346 on sUA reduction and the degree of renal impairment as measured by estimated glomerular filtration rate (eGFR) (correlation coefficient r=0.84; p=0.002). In gout patients with advanced CKD, the intestinal tract becomes the primary route of elimination for urate, and ALLN-346 is specifically designed to capitalize on this physiologic adaptation by enhancing the breakdown and secretion of urate in the intestinal tract.
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The sUA data analyzed from the full group of 16 patients during the one-week treatment period are shown graphically below:
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The second Phase 2a trial of ALLN-346, Study 202, is a two-week, outpatient study designed to assess safety and tolerability in hyperuricemic patients with gout and CKD. Patients are randomized (2:1) to receive either five capsules of ALLN-346 or a matching placebo three times daily. Cohort A enrolled seven patients with Stage 2, or mild CKD (eGFR of 60-89 mL/minute) and Cohort B enrolled 12 patients with Stage 3, or moderate CKD (eGFR of 30-59 mL/minute). The planned Cohort C (patients with Stage 4 CKD, eGFR of 15-29 ml/min) and Cohort D (patients with Stage 3 CKD, eGFR of 30-59 ml/min, in combination with allopurinol treatment) are designed to evaluate up to 24 subjects per cohort to assess safety and serum urate changes in the patient populations which the Company believes are most representative of the expected target populations for ALLN-346.
Data from Cohorts A and B are summarized graphically below. In Study 202 mean percent reductions from baseline in sUA on days seven and fourteen were between zero and five percent for patients treated with ALLN-346, vs. an increase of two to five percent from baseline seen in the placebo group. These changes were not statistically significant. Numerically larger responses were observed in Cohort B, which included patients with more severe CKD, compared with Cohort A, which the Company believes provides further evidence for the GI-based mechanism of action of ALLN-346. However, the positive correlation between the effect of ALLN-346 on sUA reduction and the degree of renal impairment as measured by estimated glomerular filtration rate seen in Study 201 was not seen in Study 202. Two out of eleven ALLN-346 treated patients, and no placebo treated patients, experienced a gout flare. There are several possible triggers for gout flares, including the initiation of urate lowering therapy.
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ALLN-346 was well tolerated, and analysis of clinical and laboratory parameters revealed no significant safety signals. The Company believes that the aggregate safety data from Study 201 and cohorts A and B of Study 202 allow for the possibility of opening cohort C in patients with more advanced CKD and cohort D in patients being treated with allopurinol.
Corporate Update
The Company is continuing to evaluate the data from cohorts A and B of Study 202 and the long-term viability of the ALLN-346 clinical program. In light of the clinical data observed to date, in particular the data from Study 201, which demonstrated a potential GI-based mechanism of action, it is possible that the clinical effect could be more pronounced in a more acute patient population (cohort C) or when used in combination with allopurinol (cohort D). However, the Company currently lacks the financial resources to conduct these studies.
As previously disclosed, the Company has initiated a strategic process to explore a range of strategic and financing alternatives to maximize shareholder value, including but not limited to securing financing to enable further development of the ALLN-346 clinical program. However, there can be no assurance that this strategic process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed.
The Company needs to raise capital imminently to continue as a going concern. Adequate financing may not be available on acceptable terms, or at all. The failure to obtain sufficient funds on commercially acceptable terms to fund the Company's operations and satisfy the Company's obligations to creditors will likely have a material adverse effect on the Company's business, results of operations and financial condition and jeopardize its ability to continue operations in the near-term. Unless the Company can raise capital to fund operations, it will need to implement additional cost reduction strategies, including, among others, amending, delaying, limiting, reducing, or terminating the development program for ALLN-346, and it will likely need to seek an in-court or out-of-court restructuring of its liabilities. In the event of such future restructuring activities, holders of the Company's common stock and other securities will likely suffer a total loss of their investment.
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Forward-Looking Statements
This Current Report on Form 8-K 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 ALLN-346; and statements regarding
Allena's financial position and need for capital. Any forward-looking statements
in this Current Report on Form 8-K 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.
Additional 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; risks associated with Allena's financial condition
and its need to obtain additional funding to support its business activities,
including the future clinical development of ALLN-346, and its ability to
continue as a going concern; risks associated with Allena's dependence on third
parties; risks related to the COVID-19 coronavirus; risks associated with
Allena's ability to identify and consummate financing and strategic alternatives
that yield additional value for shareholders; the timing, benefits and outcome
of the Allena's strategic alternatives review process, including the
determination of whether or not to pursue or consummate any strategic
alternative, the structure, terms and specific risks and uncertainties
associated with any potential strategic transaction, potential disruptions in
Allena's business and stock price as a result of its exploration, review and
pursuit of strategic alternatives or the public announcement thereof and any
decision or transaction resulting from such review. 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 Allena's Quarterly Report
on Form 10-Q for the quarter ended
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description 104 Cover Page Interactive Data File (Embedded within the Inline XBRL Document).
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