AIM ImmunoTech Announces Ethics Committee Approval to Commence Phase 1 Clinical Study of Ampligen as an Intranasal Therapy

Rhea-AI Summary

AIM ImmunoTech Inc. (NYSE American: AIM) has received Ethics Committee approval in the Netherlands for its Phase 1 clinical study of Ampligen as an intranasal therapy for COVID-19 and respiratory viral diseases. The study will enroll 40 healthy subjects to evaluate safety and tolerability over 13 days. CEO Thomas K. Equels expressed optimism about the potential of Ampligen, noting previous results that showed a 90% reduction in SARS-CoV-2 infection in vitro. Enrollment is expected to start in Q1 2021.

Positive

• Ethics Committee approval obtained for Phase 1 clinical study of Ampligen.
• Study aims to evaluate safety and tolerability in 40 healthy subjects.
• Previous in vitro results showed Ampligen reduced SARS-CoV-2 viral yield by 90%, indicating strong potential.

Negative

• Future success of the trial is uncertain, with potential regulatory hurdles ahead.
• No assurances that Ampligen will be effective as an intranasal therapy for COVID-19.

OCALA, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy, a critical step in the company’s ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.

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. This will 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.

“We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of the trial,” said AIM CEO Thomas K. Equels. “We are on track for site initiation later this month and expect to begin enrolling participants in the study during the first quarter of 2021. Importantly, our 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 concentrations. As a result, we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19 and are excited to commence safety tests of potential dosing regimens.”

Dr. Matthijs Moerland, principal investigator at CHDR: “We’re very happy helping AIM with this important step. Together with AIM’s study team, we feel we have not only designed a trial evaluating Ampligen’s intranasal safety profile, but also yielding important mechanistic data on the compound’s immunomodulatory activities.”

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. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. 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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3611a63e-e942-4a1e-9f9e-b463ef0a224a

FAQ

What is the purpose of AIM's Phase 1 clinical study for Ampligen?

The study aims to evaluate the safety and tolerability of Ampligen as an intranasal therapy for COVID-19 and other respiratory viral diseases.

How many subjects will be enrolled in the AIM study?

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

When is the enrollment for AIM's Ampligen study expected to begin?

Enrollment is expected to begin during the first quarter of 2021.

What were the results of previous studies on Ampligen's effectiveness against SARS-CoV-2?

Previous in vitro studies demonstrated that Ampligen could decrease SARS-CoV-2 viral yields by 90%.

What are the potential risks associated with AIM's clinical study?

The study faces risks such as lack of regulatory approval, potential delays in enrollment, and the need for further testing to confirm Ampligen's effectiveness.