Phase 2b/3 study may proceed under U.S.
Investigational New Drug application
Study design now accepted by U.S. and U.K.
regulatory authorities
Axcella to present at Long COVID forum
co-sponsored by BIO and Solve M.E.
Axcella to host a conference call February 16
at 8:00 a.m. ET; To register, click here
Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage
biotechnology company pioneering novel approaches to treating
complex diseases using multi-targeted endogenous metabolic
modulator (EMM) compositions, today announced its Investigational
New Drug (IND) application to initiate a phase 2b/3 trial in the
U.S. for AXA1125 in the treatment of Long COVID Fatigue has been
cleared by the U.S. Food and Drug Administration (FDA). The company
reported that it had received regulatory guidance from the FDA,
supporting a trial that is designed to serve as the registration
trial for patients with Long COVID Fatigue. The study design now
has acceptance from both the U.S. and U.K. regulatory authorities.
Last month, the company announced a regulatory path to registration
of AXA1125 in the treatment of Long COVID Fatigue, and that it had
received regulatory guidance from The Medicines and Healthcare
products Regulatory Agency (MHRA), the U.K.’s regulatory agency,
supporting a single trial that could serve as the registration
trial for patients with Long COVID Fatigue.
The guidance from the FDA and the MHRA follows the company’s
submission of materials to both regulatory agencies including
results from the Phase 2a randomized, double-blind,
placebo-controlled investigation to evaluate the efficacy and
safety of AXA1125 in patients with fatigue related to Long COVID.
The study found that subjects who received AXA1125 experienced
clinically and statistically significant improvement in mental
(p=0.0097) and physical (p=0.0097) fatigue scores compared to
placebo subjects. Consistent with the Ph2a trial, the Ph2b/3 trial
will enroll participants who have had fatigue for at least 12 weeks
after COVID-19 infection. The primary endpoint will utilize the
same patient reported outcome tool, the Chalder Fatigue
Questionnaire (CFQ-11), to measure improvements in fatigue.
Additional endpoints will evaluate improvements in physical
function, quality of life, and ability to return to work.
Participants will receive either placebo or AXA1125 for three
months.
“We’re excited to now have the regulatory clearance from both
the U.S. and U.K. authorities to advance our Long COVID program
into a trial that can lead to registration,” said Bill Hinshaw, CEO
of Axcella. “The guidance from the FDA demonstrates continued
progress, following the MHRA milestone a few weeks ago, providing
clear next steps in this important, ongoing, and as-yet untreated
disease. There are millions of people around the world suffering
from Long COVID Fatigue who are without options. Axcella has the
leading program in the field, and this regulatory feedback provides
the next step in developing a potential Long COVID Fatigue
treatment.”
“We are pleased to obtain FDA clearance for this phase 2b/3
study, following our positive feedback from the MHRA,” said
Margaret Koziel, M.D., Chief Medical Officer of Axcella. “Both on
an individual and a societal level, the impact of Long COVID on the
ability to have a full and productive life is significant, and we
hope to offer a solution to these patients.”
Dr. Koziel will be presenting at a forum on February 21 that
will bring hundreds of stakeholders together to discuss how the
government and private industry can foster greater and more urgent
public-private engagement on treatments for Long COVID. The forum
is co-sponsored by the Biotechnology Innovation Organization (BIO)
and SOLVE M.E., a non-profit organization that serves as a catalyst
for critical research into diagnostics, treatments, and cures for
myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long
COVID and other post-infectious diseases. Axcella will make a
presentation at the forum to discuss its novel approach to treating
Long COVID Fatigue and its promising clinical data.
“Treatment with AXA1125 resulted in statistically significant
improvement in mental and physical fatigue scores, compared to
placebo, in a well-designed and carefully conducted randomized
controlled trial,” added Jason Maley, M.D., Director of the Beth
Israel Deaconess Medical Center COVID-19 Survivorship Program. “I’m
eager to see AXA1125 move into a phase 2b/3 study. This work is
important to help patients with Long COVID who commonly experience
debilitating daily fatigue.”
“There remains an urgent need for treatment developed
specifically for the millions of patients suffering from Long COVID
Fatigue, a disease that is having a devastating health and economic
impact,” said Oved Amitay, Chief Executive Officer of Solve M.E.
Amitay, who also is the co-founder of the Long COVID Alliance, a
network of patient-advocates, scientists, disease experts, and drug
developers focused on educating policy makers and accelerating
research into post-viral illnesses, added, “I am looking forward to
the conversation at the BIO and SOLVE forum, where I expect
multiple stake-holders to continue to advance progress for Long
COVID patients.”
Long COVID is a persistent and growing long-term consequence of
the pandemic, affecting an estimated one hundred million patients
worldwide, with fatigue as the most commonly reported symptom.
Recent estimates indicate that 15-20% of Americans with COVID have
persisting health issues,i up to four million Americans are out of
work due to Long COVID symptoms, and that Long COVID has
contributed to approximately $1 trillion in lost earnings and $544
billion in increased medical spending.ii
Investor Conference Call Information Axcella will
host a live conference call and webcast at 8:00 a.m. ET on
Thursday, February 16, 2023. Participants include Bill Hinshaw, Dr.
Margaret Koziel, and Dr. Jason Maley. To access the live conference
call, please dial 844-808-7139 (domestic) or 412-902-0127
(international) and refer to “Axcella Health.” A webcast of the
call will also be available under "Events and Presentations" in the
Investors section of the Axcella Health website at
https://ir.axcellatx.com/. The archived webcast will be available
on Axcella’s website approximately two hours after the conference
call and will be available for 90 days following the call.
About Axcella Therapeutics (Nasdaq: AXLA) Axcella
is a clinical-stage biotechnology company pioneering a new approach
to treat complex diseases using compositions of endogenous
metabolic modulators (EMMs). The company’s product candidates are
comprised of EMMs and derivatives that are engineered in distinct
combinations and ratios to reset multiple biological pathways,
improve cellular energetics, and restore homeostasis. Axcella’s
pipeline includes lead therapeutic candidates for the treatment of
Long COVID, NASH, and the reduction in risk of OHE recurrence. 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 potential
utility of AXA1125 as a treatment of Long COVID and the Company’s
anticipated regulatory pathway for AXA1125 and the timing and
potential success thereof. 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 AXA1125, other
potential impacts of COVID-19 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 AXA1125, the clinical development and safety
profile of AXA1125 and its 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.
_________________________ i Bull-Otterson
L, Baca S, Saydah S, et al. Post–COVID Conditions Among Adult
COVID-19 Survivors Aged 18–64 and ≥65 Years — United States, March
2020–November 2021. MMWR Morb Mortal Wkly Rep 2022;71:713–717. DOI:
http://dx.doi.org/10.15585/mmwr.mm7121e1external icon
ii Bach K. New data shows long Covid is
keeping as many as 4 million people out of work. Brookings
Institute. August 24, 2022.
https://www.brookings.edu/research/new-data-shows-long-covid-is-keeping-as-many-as-4-million-people-out-of-work/#footnote-3
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230215005787/en/
ir@axcellatx.com
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