AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions
10 Juli 2023 - 2:05PM
AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study
Evaluating Ampligen® for the Treatment of Post-COVID Conditions
AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”)
today announced it has enrolled and dosed the first subject in the
company’s Phase 2 study evaluating Ampligen® as a potential
therapeutic for people with post-COVID conditions (“AMP-518”). This
important study milestone follows on the heels of the company
having recently opened multiple clinical study sites and having
screened numerous subjects. Study screening is ongoing and AIM
expects to dose additional new subjects in the coming weeks. For
more information about AMP-518, please visit ClinicalTrials.gov and
reference identifier NCT05592418.
AIM Chief Executive Officer Thomas K. Equels
commented, “We have clinical sites up and running, and we expect
additional sites to be open in the very near future. AIM knows how
vital it is to keep building on this momentum. By developing
Ampligen as a therapeutic for Long COVID with chronic fatigue-like
symptoms, we are working to bring hope to the millions of people
struggling with this debilitating and life-altering syndrome. Long
COVID is a major unmet medical need — in other words, there is no
approved therapy available for this major health problem, and we
believe that Ampligen has the potential to be a therapeutic
solution.”
Oved Amitay, President and CEO of the national
advocacy organization Solve M.E., commented, “Post-COVID conditions
are a looming public health crisis. The CDC estimates that 1.6% of
adults in the U.S. are struggling with significant activity
limitations from Long COVID, presenting extreme challenges for
patients, their caregivers and families. We are encouraged by the
progress of the AMP-518 clinical study, and the potential for this
therapeutic to address debilitating aspects of these conditions and
to bring hope to the millions of people affected by Long COVID, as
well as the many other 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.
AMP-518 is expected to enroll approximately 80
subjects between the ages of 18 to 60 years across up to 10 centers
in the United States. Subjects will be randomized 1:1 to receive
twice weekly IV infusions of Ampligen or placebo for 12 weeks, with
a follow-up phase of two weeks.
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 in clinical trials 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 Post-COVID. 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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