AIM ImmunoTech Announces Completion of Enrollment in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions
08 Agosto 2023 - 7:05AM
AIM ImmunoTech Announces Completion of Enrollment in Phase 2 Study
Evaluating Ampligen® for the Treatment of Post-COVID Conditions
AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”)
today announced the completion of enrollment in the company’s Phase
2 study evaluating Ampligen® as a potential therapeutic for people
with post-COVID conditions (“AMP-518”).
The study has met the planned enrollment of 80
AMP-518 subjects ages 18 to 60 years who have been randomized 1:1
to receive twice-weekly intravenous infusions of Ampligen or
placebo for 12 weeks, with a follow-up phase of two weeks. The
company expects to complete dosing of the last study patient in Q4
2023. Topline data is expected as early as Q1 2024.
AIM Chief Executive Officer Thomas K. Equels
commented, “We are incredibly pleased with the extremely rapid pace
of enrollment for AMP-518. The completion of enrollment in such a
short timeframe highlights the unmet medical need for a therapeutic
option to treat Long COVID with chronic fatigue-like symptoms. We
continue to be encouraged by the potential of Ampligen and are
working diligently to bring this study across the finish line with
the ultimate goal of helping the millions of people struggling with
this debilitating and life-altering syndrome.”
Oved Amitay, President and CEO of the national
advocacy organization Solve M.E., commented, “The CDC estimates
that approximately four million Americans are struggling with
significant activity limitations from Long COVID, presenting
extreme challenges for patients, their caregivers and their
families. Complete AMP-518 study enrollment is a critical step in
the ongoing effort to develop Ampligen as a therapeutic to address
the debilitating aspects of Long COVID and to bring hope not only
to the millions of people affected by this disease, but also to the
many people suffering from associated conditions such as myalgic
encephalomyelitis, also known as chronic fatigue syndrome or
ME/CFS.”
The AMP-518 clinical trial is a two-arm,
randomized, double-blind, placebo-controlled, multicenter study to
evaluate efficacy and safety of Ampligen in subjects experiencing
the post-COVID condition of fatigue. The primary protocol planned
outcome measure of the study is change from baseline to week 13 in
PROMIS® Fatigue Score. Other protocol planned study outcomes
include: change from baseline to week 6 in PROMIS® Fatigue Score;
change from baseline to weeks 6 and 13 in distance traveled during
a Six-Minute Walk Test; proportion of subjects that surpass 54
meters in the Six-Minute Walk Test at the end of 12-week treatment
phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive
Function Score; and change from baseline to weeks 6 and 13 in
PROMIS® Sleep Disturbance Score.
For more information about AMP-518, please visit
ClinicalTrials.gov and reference identifier NCT05592418.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company
focused on the research and development of therapeutics to treat
multiple types of cancers, immune disorders and viral diseases,
including COVID-19. The company’s lead product is a first-in-class
investigational drug called Ampligen® (rintatolimod), a dsRNA and
highly selective TLR3 agonist immuno-modulator with broad spectrum
activity for globally important cancers, viral diseases and
disorders of the immune system.
For more information, please visit aimimmuno.com
and connect with the company on Twitter, LinkedIn, and
Facebook.
About Solve M.E.
The Solve ME/CFS Initiative (Solve M.E.) is 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-infection diseases. Solve M.E.’s. work with the
scientific, medical, and pharmaceutical communities; advocacy with
government agencies; and alliances with patient groups around the
world is laying the foundation for breakthroughs that can improve
the lives of millions who suffer from various “long haul”
diseases.
Cautionary Statement
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,”
“expect,” “plan,” “anticipate” and similar expressions (as well as
other words or expressions referencing future events or
circumstances) are intended to identify forward-looking statements.
Many of these forward-looking statements involve a number of risks
and uncertainties. Among other things, for those statements, the
company claims the protection of safe harbor for forward-looking
statements contained in the PSLRA. The information relied upon for
this Study is primarily derived from preliminary data from a small
number of subjects. Significant additional testing and trials will
be required to determine whether Ampligen® will be effective in the
treatment of Post-COVID conditions. No assurance can be given as to
whether the Phase 2 Study will be successful or yield favorable
data or require additional funding. The company does not undertake
to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof.
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