AIM ImmunoTech Announces Positive Safety Data from the Third Cohort of Its Phase 1 Intranasal Clinical Trial

Rhea-AI Summary

AIM ImmunoTech Inc. announced the completion of dosing for Cohort 3 in a Phase 1 clinical study investigating Ampligen as an intranasal therapy. The study, conducted by the Centre for Human Drug Research, involved 40 healthy subjects and reported no serious adverse events. Cohorts received escalating doses up to 500 μg, with Cohort 4 now receiving 1250 μg. The study aims to evaluate Ampligen’s safety and biological activity as a potential treatment for COVID-19 and other viral diseases. Future updates depend on ongoing trial results and regulatory approvals.

Positive

• Completion of Cohort 3 dosing without serious adverse events.
• Progression to Cohort 4, increasing the dose to 1250 μg.
• Study aimed at evaluating Ampligen's potential in treating COVID-19.

Negative

• Uncertainty regarding future study results and regulatory approvals.
• Potential delays in clinical trial enrollment due to COVID-19.

OCALA, Fla., May 26, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has completed dosing of Cohort 3 in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as an intranasal therapy, reporting no serious adverse events.

This is consistent with results in the first two cohorts of the study and at escalating doses.The study protocol called for a total of 40 healthy subjects to receive repeated administration of either Ampligen or a placebo. Subjects in Cohort 1 received 75 μg of Ampligen, subjects in Cohort 2 received 200 μg of Ampligen and subjects in Cohort 3 received 500 μg. The study is already proceeding with Cohort 4, with subjects receiving 1250 μg.

The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the Phase 1 clinical study AMP-COV-100 (CHDR2049), titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C₁₂U) in Healthy Subjects.” AIM is sponsoring and funding the clinical study.

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 disease caused by the SARS-CoV-2 virus.

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 cannot assure that the CHDR study will be successful or continue to yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Contacts:

Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com

AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com

FAQ

What were the results of AIM ImmunoTech's Phase 1 clinical study on Ampligen?

The Phase 1 clinical study reported no serious adverse events after dosing Cohort 3, which received a 500 μg dose of Ampligen.

How many cohorts are there in the AIM ImmunoTech Ampligen study?

The study has progressed through three cohorts, with Cohort 4 currently receiving 1250 μg of Ampligen.

What is the purpose of the AIM ImmunoTech Ampligen study?

The study evaluates the safety, tolerability, and biological activity of Ampligen as an intranasal therapy in healthy subjects.

What is the stock symbol for AIM ImmunoTech?

AIM ImmunoTech trades under the stock symbol 'AIM' on the NYSE American.

What are the next steps for AIM ImmunoTech after Cohort 3 results?

The study will continue with Cohort 4, and future results will depend on ongoing trials and regulatory approvals.