AIM ImmunoTech Inc. (NYSE:AMERICAN) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases — including COVID-19, the disease caused by the SARS-CoV-2 virus — today reported positive preliminary pilot study data from its ongoing Expanded Access Program (“EAP or “AMP-511”) evaluating its investigational drug, Ampligen, as a therapeutic for “long COVID”. The preliminary data from this uncontrolled clinical trial found that patients reported statistically significant improvements in chronic fatigue after treatment with Ampligen. Based on these early results, AIM is working to move forward with a Phase 2 controlled trial.
Ampligen is AIM’s RNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen modulates the immune system and has demonstrated antiviral activity.
“Post-COVID conditions are debilitating, can be brutally agonizing and affect millions of people who are suffering without any viable treatment options. The positive preliminary data demonstrated in this pilot study bolsters our confidence in the potential of Ampligen as we continue to drive its development as a potential therapeutic for the treatment of long COVID. With the positive preliminary results demonstrated to date we remain, now more than ever, steadfast in our mission to bring an effective therapeutic option to those in need,” stated Thomas K. Equels, CEO of AIM ImmunoTech.
AMP-511 is an ongoing, prospective, open-label, multi-center Phase 3 study to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) patients with Ampligen. The study was amended in October 2020 to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who then demonstrate chronic fatigue-like symptoms — referred to as Post-COVID Conditions. There have been four Post-COVID subjects treated in this amendment “pilot” program. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev.
To be included under the amendment, subjects must meet the 1988 or 1994 CDC Case Definition for CFS. Their fatigue must have persisted or recurred during 3 or more consecutive months of illness and must not have preceded the onset of the COVID-19 symptoms. During the study, subjects are evaluated at baseline (Week 0) using a Post-COVID-19 Questionnaire. They then begin treatment with Ampligen and the COVID induced fatigue conditions are evaluated over time.
Patients receive open label intravenous (IV) Ampligen twice weekly, with the dose escalating up to 400 mg if well-tolerated.
The first four enrolled Post-COVID patients were treated in the study. Evaluation of safety is a secondary objective in this study. The initial findings for these four enrolled patients are as follows:
| AMP-511 Preliminary Data: Post-COVID Condition of Fatigue Over Time | ||||||||||||
| Patient 1 | Patient 2 | Patient 3 | Patient 4 | |||||||||
| BSL | Wk 6 | Wk 12 | BSL | Wk 6 | Wk 12 | BSL | Wk 6 | Wk 12 | BSL | Wk 6 | Wk 12 | |
| Inability to exercise or be active | 10.0 | 10.0 | 7.0 | 8.0 | 5.0 | 4.0 | 10.0 | 8.0 | 7.0 | 9.0 | 7.0 | 8.0 |
| Fatigue | 9.5 | 8.0 | 6.0 | 6.0 | 3.0 | 3.0 | 9.0 | 8.0 | 7.0 | 8.0 | 7.0 | 7.0 |
| Post exertional malaise (tiredness the day after exercise) | 7.5 | ND | 2.0 | 6.0 | ND | 1.0 | 8.0 | ND | 5.0 | 8.0 | ND | 9.0 |
| Wilcoxon matched-pairs signed rank test measuring changes in total improvement (combining exercise ability, fatigue, and post-exertional malaise) at week 12 compared to baseline: p=0.002
BSL = baseline; Baseline is mean of 2 baseline values ND=Not done; Post exertional malaise was not collected at week 6 Severity Scores: 1-3= Mild, 4-6= Moderate, 7-8= Severe, 9-10= Very Severe |
||||||||||||
The reduction in fatigue observed in the first four patients provide preliminary evidence of Ampligen’s effect in the Post-COVID Condition of fatigue. As shown from these data, by week 12, compared to baseline, there was what the investigators considered a clinically significant decrease in fatigue-related measures.
Dr. Lapp commented, “While still early, we are very encouraged by this promising data and the significant improvement in fatigue and the ability to be active, especially in the category of post-exertional malaise. We remain committed to advancing development of Ampligen as a therapeutic for the treatment of Long COVID — or Post-Acute Sequelae of Covid (PASC) — and look forward to further evaluating its potential.”
Based in part on these early positive data, AIM is continuing to work toward filing an IND application with the FDA for a Phase 2 study of Ampligen for the treatment of Post-COVID conditions. The planned IND is for 12 weeks of therapy.
Dr. Peterson commented, “As we are aware of the previous successes of Ampligen Poly I:Poly C12U in the treatment of a select group of subjects with Chronic Fatigue Syndrome, I began consideration of subjects with well-documented long COVID syndrome for the use of Ampligen per the approved protocol. The first subject fulfilled the current criteria for long COVID disease and had no contraindications. The subject was begun on Ampligen under the protocol and had a gradual and consistent improvement observed by myself, the subject’s family, as well as the nursing staff. The subject has had a dramatic improvement in energy and cognitive function with near complete clearing of her brain fog. The subject will continue according to the protocol to maximal clinical improvement. Due to the subject’s rather dramatic improvement in a relatively short period of time, I have proposed an additional five subjects for entry into the Ampligen protocol for long COVID.”
