Ampligen Embarks on Phase I Intranasal Study
AIM ImmunoTech, a trailblazing biotechnology company, has initiated a pivotal Phase I clinical study to evaluate the efficacy of Ampligen, its groundbreaking drug, as an intranasal therapy for combating COVID-19 and other respiratory viral infections. This study marks a significant milestone in AIM’s unwavering pursuit of developing Ampligen as a potential prophylactic or treatment for these debilitating diseases.
Collaboration and Ethical Approval
This latest development is the culmination of AIM’s collaboration with the Centre for Human Drug Research (CHDR) and the meticulous review and approval process by the Dutch local Ethics Committee. This endorsement underscores the rigorous scientific foundation and ethical considerations underpinning the study.
Study Design and Objectives
The Phase I study will enroll 40 healthy participants, divided into four Ampligen treatment groups and a placebo group. Each participant will receive intranasal doses of Ampligen every other day for 13 days, totaling seven doses per individual. The study aims to assess the safety, tolerability, and biological activity of repeated intranasal Ampligen administration.
Promising Preclinical Data
Prior in vitro modeling conducted at the Institute for Antiviral Research at Utah State University demonstrated Ampligen’s remarkable ability to reduce SARS-CoV-2 infectious viral yields by an impressive 90% at clinically achievable intranasal Ampligen dosage concentrations. These findings provide a strong scientific rationale for the ongoing clinical study.
AIM’s Commitment to Innovation
AIM ImmunoTech remains steadfast in its mission to develop innovative therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19. The company’s unwavering dedication to scientific research and clinical development is evident in its ongoing efforts to bring Ampligen to the forefront of respiratory virus treatment.
Expanding Access to Ampligen
In a parallel development, AIM recently dosed its first ‘long hauler’ COVID-19 patient in the AMP-511 Expanded Access Program (EAP). This program provides access to Ampligen for patients suffering from chronic fatigue-like symptoms following COVID-19 infection. AIM’s unwavering commitment to patient care extends beyond clinical trials, ensuring that those in need have access to potential treatments.
