AIM ImmunoTech Reports Positive Topline Results from Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions
08 Febbraio 2024 - 2:50PM
AIM ImmunoTech Inc.
(NYSE American: AIM) (“AIM” or the “Company”)
today announced positive topline results from the Company’s Phase 2
study evaluating the efficacy and safety of Ampligen® as a
potential therapeutic for people with the Post-COVID condition of
fatigue (“AMP-518”).
The AMP-518 clinical trial was a two-arm,
randomized, double-blind, placebo-controlled, multicenter study.
The primary outcome measure is change from baseline to week 13 in
PROMIS® Fatigue Score. Although the reduction in that measure did
not show a significant difference at the 13-week time point,
initial analysis revealed that subjects in the Ampligen group had
experienced lower levels of fatigue at multiple time points during
the treatment phase when compared to the placebo group. An analysis
of secondary and ad hoc endpoints found that the difference in
change from baseline in PROMIS® Fatigue Score between the Ampligen
and placebo groups reached or approached statistical significance
at several timepoints during the treatment phase. The Six-Minute
Walk Test also revealed a higher impact of Ampligen on distance
traveled in six minutes at Week 13 compared to placebo.
AIM Chief Executive Officer Thomas K. Equels
stated: “I’m very much encouraged by these results and the fact
that the Ampligen group outperformed the placebo group in PROMIS®
measures of fatigue in 12 of the 13 weeks tracked. Ampligen’s
positive impact on the objective six-minute walk test is also very
encouraging and useful for future trial design. This promising
initial data helps solidify our belief that AIM is on the right
path with the development of Ampligen for the Post-COVID condition
of fatigue. Also as expected, Ampligen was generally well tolerated
in this indication.”
Eighty (80) subjects were enrolled in AMP-518,
and forty (40) were randomized to each treatment group. Of the 80
enrolled subjects, 66 subjects (82.5%, 66/80) completed the
treatment, which consisted of 36 subjects (90.0%, 36/40) in the
Ampligen group and 30 subjects (75.0%, 30/40) in the placebo group.
The primary reasons for discontinuation from treatment included
withdrawal by subject, lost to follow-up, and adverse event.
Demographics and baseline characteristics were generally comparable
between the Ampligen and placebo groups.
AIM Scientific Officer Chris McAleer, PhD.,
stated: “The topline report is encouraging and indicates that
Ampligen improves measures of fatigue over placebo, with portions
of this data approaching statistical significance. And while we
believe the statistical significance could be improved with more
subjects, this was a small proof-of-concept study and was not
powered for significance. I’m eager to receive the complete study
report, which will have outcomes for all secondary readouts, as
well as individual subject data. This will allow us to do in-depth
analysis and to use these preliminary data to calculate the sample
size necessary to achieve high statistical power in future
trials.”
Additionally, the analysis of safety parameters
demonstrated that Ampligen was generally well-tolerated with no
severe adverse events, no treatment-emergent adverse events (TEAEs)
leading to death, and no severe TEAEs reported during the study.
There were six subjects (15.0%) in the Ampligen group with TEAEs
considered related to the study treatment, the majority of which
were mild in severity. Two subjects in the Ampligen group had TEAEs
leading to treatment discontinuation or interruption. More subjects
in the Ampligen group compared to the placebo group reported TEAE
(10 subjects, 25.0% vs. four subjects, 10.0%), however the majority
of these were mild.
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 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.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,” “continue,” “believe,” “potential,”
“upcoming” and other variations thereon 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. There are no guarantees of future success in
this or related clinical trials. Additionally, this
proof-of-concept study was not powered for significance, meaning
that any results are not necessarily statistically significant.
Further, while primary and secondary endpoint data suggests a
positive signal, it is not necessarily indicative of results that
might occur in a pivotal trial powered to achieve statistical
validity. The Company urges investors to consider specifically the
various risk factors identified in its most recent Form 10-K, and
any risk factors or cautionary statements included in any
subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities
and Exchange Commission (the “SEC”). You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. Among other things, for
those statements, the Company claims the protection of the safe
harbor for forward-looking statements contained in the PSLRA. The
Company does not undertake to update any of these forward-looking
statements to reflect events or circumstances that occur after the
date hereof.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/f8ccfdde-6cd3-4bad-a143-bac667f1950d
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
AIM@jtcir.com
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