Benzinga | Jun 21, 2021 09:02AM EDT

AIM ImmunoTech Says Completes All Treatments In Phase 1 Human Safety Study Of Intranasal Administration Of Ampligen

AIM ImmunoTech Inc. (NYSE:AIM) today announced 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 final study report is expect in the third quarter of 2021.



A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the 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.

With these positive preliminary results in hand, the Company is now moving forward with the initial planning and negotiations for a follow-up Phase 2 study testing Ampligen as a potential broad-spectrum respiratory virus prophylaxis. 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). This Phase 2 study will test this proposition in humans. A successful Phase 2 study could also establish Ampligen as a potential prophlyaxis against future viral variants and future novel respiratory viruses for which there are no current therapies. Moreover, 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 cruises, cargo or miltary ships; people on commercial airplanes; and service personnel in close quarters on military installations.