After reporting positive data in a small subset of patients with long Covid, AIM ImmunoTech is seeking an IND for a Phase II trial of Ampligen in long Covid in 2022.

The planned Phase II trial would enroll 80 long patients experiencing the long Covid condition of fatigue in a multicenter Phase II trial, says Deputy Chief Science Officer Chris McAleer, PhD. Half of the patients will receive intravenous (IV) therapy of Ampligen twice weekly, and the other half will take placebo, McAleer tells Clinical Trials Arena.

AIM ImmunoTech is in the midst of pre-IND discussions with the FDA regarding the Phase II trial, CEO Thomas Equels adds. The biotech plans to recruit through multiple sites in the US, though it is possible the company will conduct studies in Europe as well, he notes.

On July 28, AIM ImmunoTech reported positive results for four patients with long Covid receiving Ampligen as part of an expanded access study (NCT00215813). The trial was originally designed for patients with chronic fatigue syndrome (CFS) but expanded to include some patients with long Covid symptoms of fatigue.

“We believe that this pilot study—where we’re getting basically 100% response in a very small sample—compels us to move into a randomised, placebo-controlled, double-blind trial to test Ampligen in this serious unmet need,” Equels explains.

Choosing fatigue endpoints

Long Covid describes the constellation of symptoms patients can experience at least a month after an acute Covid-19 infection. In AIM ImmunoTech’s planned Phase II trial, the company will specifically focus on symptoms of fatigue and exercise capacity, McAleer says.

As a Phase II trial endpoint, AIM ImmunoTech could use the PROMIS fatigue score, an FDA-approved, self-reported questionnaire assessing fatigue levels, McAleer explains. The trial could also measure the 6-Minute Walk Test (6MWT), which the FDA recognises as a measure of fatigue and exercise capacity, he adds.

Meanwhile, a PROMIS questionnaire for cognition could serve as a secondary endpoint for the long Covid symptom of brain fog, McAleer notes. Brain fog describes the short-term memory loss, difficulty concentrating, and confusion occurring in some patients with long Covid.

Recruiting for long Covid fatigue

For a target patient population experiencing chronic fatigue, transportation to and from infusion sites can prove somewhat challenging, Equels says: “The disease itself works against us because of the nature of the symptoms.”

Nevertheless, with an estimated 23 million Americans experiencing post Covid symptoms, the unmet need for new treatments is high, McAleer says. AIM ImmunoTech plans to open up multiple sites where physicians can administer infusions of Ampligen, extending beyond the two trial locations in the expanded access study, Equels adds. The expanded access study takes place at sites in Incline Village, Nevada and Charlotte, North Carolina.

Ampligen is an immuno-modulator in development for cancers, viral diseases, and immune system disorders. The expanded access cohort was one of several long Covid trial readouts slated for the second half of 2023.