ORPH Orphazyme AS

AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company’s drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021.

A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring high infection rates for subjects who receive the drug, therefore also ensuring large data sets with potentially statistically significant results.

This Phase 2a study will come in the wake of AIM’s recent announcement that all subjects have completed treatment in the company’s Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level. A final study report is expect in the third quarter of 2021.

Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses. This Phase 2a study will test this proposition in humans.

AIM CEO Thomas K. Equels, commented: “It is our belief that Ampligen’s mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a Human Challenge Trial using hRV and Influenza allows us to test in humans Ampligen’s potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses.”

Cathal Friel, Executive Chairman of Open Orphan, stated: “We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product and to demonstrate our expertise in testing vaccines and antivirals using our world-leading portfolio of human challenge models. While the pandemic has undoubtedly inflicted a lot of loss and suffering globally, it has also taught us a valuable lesson in pandemic preparedness. It is my belief therefore that the infectious disease market has been utterly transformed and is going to grow exponentially in the years ahead. Challenge studies are a key weapon in the arsenal against infectious diseases as they can bring effective treatments and vaccines to the market both quicker and faster than they could otherwise.”

An Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruise, cargo or military ships; people on commercial airplanes; and service personnel in close quarters on military installations.

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.

About Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organizations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialized virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Program and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

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. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies 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 respiratory viruses, including SARS-CoV-2, 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, LLCPhone: 212-671-1021Email: aim@crescendo-ir.com

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