Receive our newsletter – data, insights and analysis delivered to you
  1. News
February 17, 2021

AIM ImmunoTech to commence study of intranasal Covid-19 therapy

AIM ImmunoTech is set to commence the Phase I clinical study of its Ampligen drug as an intranasal therapy for the treatment of Covid-19 and other respiratory viral diseases.

AIM ImmunoTech is set to commence the Phase I clinical study of its Ampligen drug as an intranasal therapy for the treatment of Covid-19 and other respiratory viral diseases.

This forms a critical step in the company’s ongoing efforts to develop the drug as a potential prophylaxis or treatment for these diseases.

The latest development comes after the company received approval from the required Ethics Committee in the Netherlands.

AIM and the Centre for Human Drug Research (CHDR) had earlier entered a sponsorship agreement for the proposed AMP-COV-100 (CHDR2049) trial. The Dutch local Ethics Committee gave clearance last week to carry out this trial.

The current study intends to enrol a total of 40 healthy participants with eight each in each of the four Ampligen treatment groups and eight people receiving placebo.

It will evaluate the safety, tolerability and biological activity of repeated intranasal administration of Ampligen.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

The participants will be given intranasal doses of the drug every other day for 13 days, for a total of seven doses each.

AIM CEO Thomas Equels said: “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 modelling 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.”

AIM is focused on researching and developing therapeutics for treating various types of cancers, immune disorders and viral diseases, such as Covid-19.

Last month, the company dosed its first Covid-19 ‘long hauler’ patient in the active AMP-511 Expanded Access Program (EAP) with the Ampligen (rintatolimod) drug for the treatment of post-Covid-19 infection chronic fatigue-like symptoms.

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU