Axcella Therapeutics Details Clinical and Operational Milestones for 2022
06 January 2022 - 11:58PM
Business Wire
- Long COVID Phase 2a top-line data anticipated in mid-2022
- EMMPACT℠ Phase 2b interim data in nonalcoholic steatohepatitis
(NASH) anticipated in mid-2022
Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage
biotechnology company pioneering a new approach to treat complex
diseases using multi-targeted endogenous metabolic modulator (EMM)
compositions, today outlined key clinical and operational
milestones that are expected for the company in 2022.
“The year 2021 was a foundational time for Axcella Therapeutics
that was highlighted by the clearance of our first investigational
new drug (IND) filings and the initiation of three Phase 2 clinical
trials,” said Axcella President and Chief Executive Officer Bill
Hinshaw. “These accomplishments set the stage for what we expect to
be an exciting and transformative 2022 as we continue to enhance
our platform, build on our science and leverage important new
clinical insights for additional potential applications. With
patient screening well underway in our Long COVID Phase 2a trial,
we remain at the forefront of the therapeutic development landscape
for this debilitating condition and are on track for a top-line
data readout mid-year. Shortly thereafter, we plan to conduct an
interim analysis from our EMMPACT Phase 2b clinical trial that will
provide the most robust data to date about AXA1125’s potential in
NASH.”
AXA1125 for Long COVID
AXA1125, a multi-targeted oral EMM composition that has shown
the potential to improve mitochondrial energetics and reduce
inflammation, is being investigated in a Phase 2a clinical trial
enrolling approximately 40 patients with Long COVID. In 2022,
Axcella expects to:
- Complete enrollment in the Phase 2a trial (first half of
2022);
- Report top-line data (mid-2022);
- Assuming positive data, engage with regulatory authorities to
discuss the potential for a registrational clinical trial of
AXA1125 in Long COVID; and
- Assuming positive data, consider AXA1125’s potential to address
mitochondrial dysfunction in conditions other than Long COVID.
AXA1125 for NASH
In past clinical studies, AXA1125 has demonstrated its potential
to reduce well-established markers of liver fat, inflammation and
fibrosis. This candidate is currently being investigated in the
EMMPACT Phase 2b clinical trial enrolling approximately 270
patients with biopsy-confirmed F2/F3 NASH. In 2022, Axcella expects
to:
- Report interim data (mid-2022); and
- Complete patient enrollment in EMMPACT.
AXA1665 for OHE
AXA1665 is a multi-targeted oral EMM composition that has shown
the potential to improve amino acid balance, ammonia metabolism,
muscle function and neurocognition in past clinical studies. This
candidate is currently being investigated in the EMMPOWER℠ Phase 2
clinical trial enrolling approximately 150 patients with a history
of overt hepatic encephalopathy (OHE). In 2022, Axcella expects
to:
- Provide an enrollment update for EMMPOWER.
About Axcella Therapeutics (Nasdaq:
AXLA)
Axcella is a clinical-stage biotechnology company pioneering a
new approach to treat complex diseases using endogenous metabolic
modulator (EMM) compositions. The company’s product candidates are
comprised of EMMs and derivatives that are engineered in distinct
combinations and ratios to restore cellular homeostasis in multiple
key biological pathways and improve cellular energetic efficiency.
Axcella’s pipeline includes lead therapeutic candidates in Phase 2
development for the reduction in risk of overt hepatic
encephalopathy (OHE) recurrence, the treatment of Long COVID, and
the treatment of non-alcoholic steatohepatitis (NASH). The
company’s unique model allows for the evaluation of its EMM
compositions through non-IND clinical studies or IND clinical
trials. For more information, please visit www.axcellatx.com.
Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding the timing of development plan disclosures, regulatory
interactions, enrollment updates and clinical trial readouts. The
words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, those related to the potential impact of COVID-19 on
the company’s ability to conduct and complete its ongoing or
planned clinical studies and clinical trials in a timely manner or
at all due to patient or principal investigator recruitment or
availability challenges, clinical trial site shutdowns or other
interruptions and potential limitations on the quality,
completeness and interpretability of data the company is able to
collect in its clinical trials of AXA1665 and AXA1125, other
potential impacts on the company’s business and financial results,
including with respect to its ability to raise additional capital
and operational disruptions or delays, changes in law, regulations,
or interpretations and enforcement of regulatory guidance, whether
data readouts support the company’s clinical trial plans and
timing, clinical trial design and target indications for AXA1665
and AXA1125, the clinical development and safety profile of AXA1665
and AXA1125 and their therapeutic potential, whether and when, if
at all, the company’s product candidates will receive approval from
the FDA or other comparable regulatory authorities, potential
competition from other biopharma companies in the company’s target
indications, and other risks identified in the company’s SEC
filings, including Axcella’s Annual Report on Form 10-K, Quarterly
Report on Form 10-Q and subsequent filings with the SEC. The
company cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made. Axcella disclaims any obligation to publicly update or
revise any such statements to reflect any change in expectations or
in events, conditions, or circumstances on which any such
statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent the company’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date. The company explicitly
disclaims any obligation to update any forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20220105005992/en/
Jason Fredette jfredette@axcellatx.com (857) 320-2236
Axcella Health (NASDAQ:AXLA)
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