AIM ImmunoTech Announces that Analysis of AMP-518 Complete Clinical Patient Data Underscores Ampligen’s Potential to Improve the Post-COVID Condition of Fatigue

Rhea-AI Summary

AIM ImmunoTech (NYSE American: AIM) has announced promising results from its AMP-518 Phase 2 clinical trial for Ampligen as a potential treatment for moderate-to-severe Post-COVID fatigue. The analysis showed that patients with Long COVID who received Ampligen were able to walk farther in a Six-Minute Walk Test (6MWT) compared to those who received a placebo.

Notably, subjects with a baseline 6MWT less than 205 meters showed significant improvement, with a mean increase of 139 meters compared to 91 meters in the placebo group. Based on these findings, AIM plans to focus future trials on patients with moderate or worse Long COVID-related fatigue. The company has also made key appointments to strengthen its medical team and research efforts in this area.

Positive

• Ampligen showed significant potential (p <0.02) in improving walking distance for Long COVID patients with severe fatigue
• Patients with baseline 6MWT <205 meters showed mean improvement of 139 meters vs 91 meters in placebo group
• Company plans to focus future trials on moderate-to-severe Post-COVID fatigue patients
• Appointment of experienced medical professionals to lead development efforts

Negative

• None.

Insights

Medical Research Analyst

The analysis of AMP-518 clinical trial data reveals promising results for Ampligen in treating moderate-to-severe Post-COVID fatigue. The significant improvement in the Six-Minute Walk Test (6MWT) for patients with baseline scores below 205 meters is particularly noteworthy. With a 52.7% increase in walking distance compared to placebo, Ampligen demonstrates potential in enhancing mobility for severely affected individuals.

However, it's important to note that this is a Phase 2 trial and further studies are needed to confirm efficacy and safety. The company's decision to focus on moderate-to-severe cases in future trials is strategically sound, potentially streamlining the path to FDA approval. Investors should monitor upcoming trial designs and results closely, as positive outcomes could significantly impact AIM's market position in the growing Long COVID treatment landscape.

Market Research Analyst

This news could have a positive impact on AIM ImmunoTech's market position. The Long COVID treatment market is largely untapped, with few effective therapies available. If Ampligen proves successful in larger trials, it could capture a significant market share. The focus on moderate-to-severe cases is particularly strategic, as these patients have the highest unmet medical need and potentially represent a more lucrative market segment.

However, investors should be cautious. The competitive landscape for Long COVID treatments is rapidly evolving and larger pharmaceutical companies may enter the space. Additionally, the timeline for further trials and potential FDA approval remains uncertain. While the news is promising, it's important to consider the long road ahead in drug development and commercialization.

Financial Analyst

From a financial perspective, this news is moderately positive for AIM ImmunoTech. While the clinical results are promising, they are still early-stage and don't guarantee commercial success. The company's focus on a specific patient population could potentially reduce development costs and time to market, which is favorable for its cash position.

However, investors should note that AIM is a small-cap biotech company ($34.5 million market cap as of September 2024) with no approved products. The company reported $38.5 million in cash and equivalents as of June 30, 2024, which provides some runway, but additional financing may be needed to fund larger trials. While the stock may see a short-term boost from this news, long-term value will depend on successful progression through clinical trials and eventual commercialization.

Company is planning a follow-up clinical trial with a focused subject population of moderate-to-severe Post-COVID-related fatigue

OCALA, Fla., Sept. 11, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced that an analysis of the complete clinical patient data from the AMP-518 clinical trial supported the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.

AIM had previously reported positive topline results from its AMP-518 Phase 2 clinical trial. In further analyzing the results of AMP-518, AIM determined that, in this study, patients with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo. AIM therefore believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects whose Long COVID-related fatigue can be categorized as moderate or worse.

AIM Medical Officer Charles Lapp, MD, stated: “Approximately two hundred meters in six minutes is generally agreed upon as the difference between a person being “home ambulatory” or “community ambulatory.” To put that simply, this tells us that a person who can make that walk is someone who is healthy and active enough to go out in their community, but people who cannot make that distance are far more likely to be homebound. For this reason, we believe that Ampligen also has the greatest potential value for Long COVID subjects whose fatigue is moderate to severe.”

Dr. Lapp was recently appointed AIM’s lead Medical Officer, having joined the Company in April 2024 to help lead development efforts for Ampligen as a potential treatment for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Long COVID. David Strayer, MD, will continue to serve as a Medical Officer of AIM on a part-time basis. Christopher F. Nicodemus, MD, FACP, who is a nationally renowned immuno-oncologist, will also be joining AIM as a consultant on September 15, 2024; Dr. Nicodemus is a member of AIM’s Scientific Advisory Board.

In related news, AIM Scientific Officer Christopher McAleer, PhD, was invited to be a panelist on Study Design at the National Institutes of Health’s “RECOVER Treating Long COVID – Navigating the Pathway Forward” meeting, being held September 23-25, 2024.

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 X, 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. Data, pre-clinical success and clinical success seen to date does not guarantee that Ampligen will be approved for the commercial treatment of Long COVID or Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 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. 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.

FAQ

What were the key findings of AIM ImmunoTech's AMP-518 Phase 2 clinical trial for Ampligen?

The AMP-518 trial showed that Long COVID patients treated with Ampligen were able to walk farther in a Six-Minute Walk Test compared to those who received a placebo. Patients with a baseline 6MWT less than 205 meters showed significant improvement, with a mean increase of 139 meters versus 91 meters in the placebo group.

How does AIM ImmunoTech (AIM) plan to focus its future clinical trials for Ampligen?

Based on the AMP-518 trial results, AIM plans to focus future clinical trials on patients with moderate-to-severe Post-COVID-related fatigue, as this group showed the most significant potential for improvement with Ampligen treatment.

What recent changes has AIM ImmunoTech made to its medical team?

AIM has appointed Dr. Charles Lapp as lead Medical Officer to help lead development efforts for Ampligen. Additionally, Dr. Christopher F. Nicodemus, a renowned immuno-oncologist, will join AIM as a consultant on September 15, 2024.

What is the significance of the 205-meter threshold in the Six-Minute Walk Test for AIM's Ampligen study?

The 200-meter threshold in the Six-Minute Walk Test is generally considered the difference between being 'home ambulatory' and 'community ambulatory'. AIM believes Ampligen has the greatest potential value for Long COVID subjects whose fatigue limits their walking ability to less than this distance, indicating moderate to severe fatigue.