AIM ImmunoTech Announces Positive Safety Data in Second Cohort of Phase 1 Clinical Study Investigating Intranasal Administration of Ampligen as a Potential Prophylaxis or Treatment for COVID-19 and Other Respiratory Viral Diseases

Rhea-AI Summary

AIM ImmunoTech Inc. (NYSE American: AIM) announced the completion of dosing for Cohort 2 in its Phase 1 clinical study of Ampligen as an intranasal therapy. No serious adverse events were reported in either Cohort 1 or Cohort 2. The study aims to evaluate Ampligen's potential as a treatment for COVID-19 and other respiratory diseases. Following the current cohort, the next dose will escalate to 500 μg, with future plans for additional cohorts. AIM confirms it will provide updates on the study as it progresses.

Positive

• Completion of dosing for Cohort 2 without any serious adverse events.
• Ongoing study aimed at developing Ampligen as a potential treatment for COVID-19.

Negative

• The success of the CHDR study remains uncertain and dependent on future data.
• Potential delays in clinical trial enrollment and reporting due to the COVID-19 situation.

OCALA, Fla., April 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has completed dosing of Cohort 2 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 (SAE). AIM also reported no SAEs in Cohort 1. The study will proceed with enrollment into Cohort 3.

The clinical study is crucial for the company’s ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the 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.

The study protocol calls 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, while subjects in Cohort 2 received 200 μg of Ampligen. The dosage will escalate to 500 μg in the next cohort, Cohort 3, with the highest level of 1250 μg planned for Cohort 4.

AIM will continue to provide interim updates on the clinical trial.

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 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 are the results of AIM's Phase 1 clinical study for Ampligen?

AIM reported no serious adverse events in Cohort 1 and Cohort 2 during the study.

When is the next cohort scheduled for the Ampligen study?

Cohort 3 will escalate the dosage to 500 μg, with plans for additional cohorts afterward.

What is the purpose of the clinical study involving Ampligen?

The study assesses Ampligen's safety and efficacy as a potential treatment for COVID-19 and other respiratory viral diseases.

What is AIM ImmunoTech's stock symbol?

AIM ImmunoTech is traded under the stock symbol AIM.

Where is the clinical study for Ampligen being conducted?

The study is conducted by the Centre for Human Drug Research (CHDR) in the Netherlands.