AIM ImmunoTech Inc (NYSE:AIM) told investors it expects to begin enrolling patients in the first quarter next year for a Phase 2 trial of its investigational drug Ampligen as a therapeutic for patients with post-COVID conditions following regulatory approval.
The US Food and Drug Administration (FDA) have cleared the firm's Investigational New Drug (IND) application for the drug AMP-518.
"We are very pleased to be able to proceed with our Phase 2 study and are prepared to advance Ampligen as a potential therapeutic for the treatment of myalgic encephalomyelitis/chronic fatigue (ME/CFS)-like post-COVID conditions, an exploding area of significant unmet medical need," said Thomas K. Equels, the CEO of AIM.
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"Post-COVID-19 Disabling Fatigue, along with other debilitating post-COVID conditions such as 'Brain Fog', continue to affect tens of millions of people worldwide.
"Based on the preliminary uncontrolled clinical data flowing from our AMP-511 study and the antiviral activity we have seen to date, we believe Ampligen has the potential to be an effective treatment option and an important solution for patients and physicians," he added.
Equels said he is "deeply grateful" for the FDA's regulatory guidance related to this important clinical trial and with the IND clearance now in hand, the company is now working to "get the study up and running as quickly and efficiently as possible".
The planned Phase 2 study will be a two-arm, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Ampligen in patients experiencing the post-COVID condition of fatigue.
Around 80 subjects between the ages of 18 to 60 are expected to be enrolled in up to 10 centers across the US, said AIM.
Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks with a follow up phase of two weeks.
AIM is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases.
Contact the writer at giles@proactiveinvestors.com