AIM ImmunoTech
Announces Phase 2a Human Challenge Trial to Test its Drug Ampligen as an
Intranasal Antiviral Prophylactic Therapy
Subjects
will be exposed under controlled clinical facilities and medical
monitoring to A/Perth/16/2009 (H3N2) or human rhinovirus (hRV-16) to
gauge Ampligen’s effectiveness against those, and potentially other
viruses
OCALA, Fla., July 09, 2021 (GLOBE NEWSWIRE) -- 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.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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