AIM ImmunoTech Announces Positive Safety Data in First 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
AIM ImmunoTech Inc. (NYSE American: AIM) has successfully completed dosing for Cohort 1 in a Phase 1 clinical study of its intranasal drug Ampligen, with no serious adverse events reported. This study aims to assess Ampligen's safety and potential as a treatment for COVID-19 and other respiratory diseases. The trial, conducted by the Centre for Human Drug Research, includes 40 healthy subjects across 4 cohorts receiving varying doses of Ampligen. AIM is optimistic about moving to Phase 2 after these initial results, which may expedite the development of Ampligen for preventive treatment.
- Completion of Cohort 1 dosing with no serious adverse events reported.
- Potential to escalate dosing in Phase 1, indicating successful initial outcomes.
- Designed to pave the way for future Phase 2 studies, which may lead to market opportunities.
- Uncertainties remain regarding the safety of higher doses in subsequent cohorts.
- No assurances that the CHDR study will yield favorable data or meet regulatory approvals.
OCALA, Fla., April 07, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy, reporting no serious adverse events, and paving the way for escalation of the dose in Cohort 2. The trial is 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.
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 the sponsor and is funding the clinical study.
The study protocol calls for the enrollment of eight healthy subjects in each of four Cohorts to receive Ampligen. In addition, two healthy subjects in each Cohort will receive placebo, for a total of 40 healthy subjects. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. This study will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The protocol design is for subjects in Cohort 1 to receive 75 μg of Ampligen or a matching placebo, Cohort 2 to receive 200 μg of Ampligen or a matching placebo, Cohort 3 to receive 500 μg of Ampligen or a matching placebo, and Cohort 4 to receive 1250 μg of Ampligen or a matching placebo.
“AIM is pleased with the positive results in this first cohort. This Phase 1 safety study is designed to test the parameters of Ampligen’s intranasal tolerance before commencing a Phase 2 study. While the higher doses that we plan to test in this Phase 1 trial may or may not be well tolerated, we plan on moving quickly into Phase 2 studies with the doses that have successfully passed these Phase 1 tests, such as the dose used in Cohort 1.” said AIM CEO Thomas K. Equels.
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 is the purpose of the AIM ImmunoTech Phase 1 clinical study for Ampligen?
What were the results of Cohort 1 in AIM's clinical trial?
When will AIM ImmunoTech move to Phase 2 of the clinical trial?
How many subjects are involved in the AIM ImmunoTech Ampligen study?
What are the potential market impacts of Ampligen if the clinical trial is successful?
