AIM ImmunoTech Completes Treatment of Last Subject in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions

Rhea-AI Summary

AIM ImmunoTech Inc. (AIM) announced the completion of dosing in the Phase 2 study for Ampligen® as a potential therapeutic for Post-COVID fatigue. No severe adverse events reported. Topline data expected in Q1 2024.

Positive

• Completion of dosing in the Phase 2 study is a positive milestone
• No severe adverse events reported so far

Negative

• Topline data expected in Q1 2024, which may be considered a potential delay

No severe adverse events reported to date

Topline data expected as early as Q1 2024

OCALA, Fla., Nov. 21, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the last subject has completed treatment in the Company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with the Post-COVID condition of fatigue (“AMP-518”).

AIM Chief Executive Officer Thomas K. Equels commented, “With dosing now complete, our AMP-518 focus turns to the next milestone of being able to report topline study data as soon as it is available. We continue to believe in the potential of Ampligen to provide a much-needed therapeutic option to treat Long COVID with chronic fatigue-like symptoms. Post-COVID conditions have emerged as a serious public health threat and a clear public need.”

As previously announced, the Company completed enrollment in the AMP-518 study in August 2023. Approximately 80 subjects, ages 18 to 60 years, were enrolled and randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. To date, no severe adverse events have been reported. The Company remains on track to report topline data as early as Q1 2024.

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 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” 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 Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

What did AIM ImmunoTech Inc. (AIM) announce?

AIM ImmunoTech Inc. (AIM) announced the completion of dosing in the Phase 2 study for Ampligen® as a potential therapeutic for Post-COVID fatigue.

When is the topline data expected?

Topline data is expected as early as Q1 2024.

How many subjects were enrolled in the AMP-518 study?

Approximately 80 subjects, ages 18 to 60 years, were enrolled and randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks.

What are the primary protocol planned outcome measures of the study?

The primary protocol planned outcome measure is the change from baseline to week 13 in PROMIS® Fatigue Score. Other outcomes include changes in cognitive function, sleep disturbance, and distance traveled during a Six-Minute Walk Test.