After hours on Friday, shares of AIM ImmunoTech Inc. (NYSE: AIM), which had gained 2.19% during normal trading, continued to rise, increasing 4.77% to $0.60.
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How did that occur?
The increase boosted the AIM stock’s weekly performance to more than 14% while keeping the monthly performance constant. AIM ImmunoTech (AIM) has revealed that it would move through with starting a Phase 2 research examining its experimental medication, Ampligen. Ampligen has the potential to be a useful therapy option and a significant answer for patients and doctors, according to the early uncontrolled clinical data emerging from AIM’s AMP-511 research and the antiviral activity it has observed thus far.
For that medication as a treatment for patients with post-COVID problems, AIM ImmunoTech has previously submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) under the name “AMP-518.” For formulations and procedures that use an Ampligen-containing composition to treat post-COVID problems, AIM ImmunoTech has pending patent applications.
In order to explore Ampligen as a possible medication for the treatment of post-COVID diseases that resemble myalgic encephalomyelitis/chronic fatigue (ME/CFS), an expanding area of major unmet medical need, AIM ImmunoTech is presently able to move forward with its Phase 2 investigation. In addition to other incapacitating post-COVID disorders like “Brain Fog,” post-COVID-19 Disabling Fatigue continues to impact tens of millions of individuals worldwide.
How will the experiment be run?
The intended Phase 2 research is a two-arm, randomized, double-blind, placebo-controlled, multicenter trial to assess Ampligen’s safety and effectiveness in patients with tiredness associated with post-COVID. Change in PROMIS Fatigue Score from baseline to week 13 is the study’s main outcome metric.
Other study results include:
- Changes in the PROMIS Fatigue Score from baseline to week 6,
- The distance covered during a 6-minute walk test from baseline to weeks 6 and 13,
- The percentage of participants, who achieved a minimal clinically important difference in the 6-minute walk test at the conclusion of the 12-week treatment phase,
- Changes in the PROMIS Cognitive Function Score from baseline to weeks 6 and 13, and
- Changes in the PROMIS Sleep Disturb Score from baseline to weeks 6 and 13.
How AIM will proceed with the trial?
Over the course of up to 10 locations in the United States, AIM ImmunoTech (AIM) will enroll about 80 individuals between the ages of 18 and 60. Patients will be randomly assigned to receive Ampligen or a placebo twice a week by IV for 12 weeks, followed by a 2-week follow-up period. In the AMP-518 trial, AIM anticipates starting patient recruitment and dosing in Q1 2023.
