AIM ImmunoTech Announces First Healthy Subjects Dosed in Phase 1 Intranasal Ampligen Clinical Study

Rhea-AI Summary

AIM ImmunoTech has commenced its Phase 1 clinical trial to evaluate the safety of Ampligen as an intranasal therapy for COVID-19 and other respiratory viral diseases. Conducted by the Centre for Human Drug Research in the Netherlands, the study will involve 40 healthy subjects. Positive preliminary in vitro results indicate that Ampligen can decrease SARS-CoV-2 viral yields by 90%. CEO Thomas K. Equels expressed optimism about Ampligen's potential in preventing COVID-19 transmission.

Positive

• Initiation of Phase 1 clinical trial for Ampligen targeting COVID-19.
• Promising in vitro results showing a 90% reduction in SARS-CoV-2 viral yield.

Negative

• Trial outcome is uncertain; success not guaranteed.
• Potential delays in clinical trial due to COVID-19 medical emergency.

Marks important milestone towards development of Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases

OCALA, Fla., March 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM’s drug Ampligen as a potential intranasal therapy. AIM’s ’s goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

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

The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. The trial is designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

The prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

Thomas K. Equels, CEO of AIM stated, “We greatly appreciate the tremendous efforts of the entire team at CHDR to help us initiate our Phase 1 study of Ampligen as a potential intranasal therapy. Our objective is to expedite the development of Ampligen as a potential prophylaxis or treatment for COVID-19. Prior results of in vitro modelling were promising, and we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19. We look forward to providing further updates as this critical trial progresses.”

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 is the purpose of AIM's Phase 1 trial for Ampligen?

The trial aims to evaluate the safety of Ampligen as a potential intranasal therapy for COVID-19 and other respiratory viral diseases.

How many subjects are involved in the Ampligen clinical study?

The study plans to enroll a total of 40 healthy subjects, divided into four treatment groups and placebo.

What were the results of the preliminary studies on Ampligen?

Preliminary studies indicated that Ampligen could reduce SARS-CoV-2 infectious viral yields by 90% at clinically achievable dosages.

What are the next steps for AIM following the trial's initiation?

AIM will monitor the trial's progress and provide updates on safety and efficacy as data becomes available.