Ocala-based company moves forward with COVID-19 drug trial

Dr. Charles Lapp holds a vial of Ampligen, which Ocala-based AIM ImmunoTech hopes to test as a treatment for long-term COVID-19-induced symptoms. [Submitted]

An Ocala-based biopharmaceutical company is nearing clinical trials of one of its drugs for the possible treatment of long-term COVID-19 symptoms.

AIM Immunotech announced on Thursday that the Institutional Review Board paved the way for a clinical trial using its drug Ampligen for post-COVID-19 treatment, according to a press release.

Ampligen was previously being used in a clinical trial for patients with chronic fatigue syndrome. Fatigue is one of the long-term effects of COVID-19, and treatment with Ampligen is geared toward “Long Haulers,” patients who suffer from COVID-19 symptoms weeks or months after contracting the virus.

“It is anticipated that COVID-19 will trigger a large number ‘long haulers’ suffering COVID induced brain impairment and disabling fatigue,” Dr. Charles Lapp of the Hunter-Hopkins Center in Charlotte, North Carolina, said in a release. “I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy.”

With nearly 17,000 cases in Marion County and over 1.27 million in the state of Florida, there will be plenty of Floridians who will suffer long-term effects from the virus. According to Johns Hopkins Medicine, chronic fatigue syndrome is defined as “profound tiredness, regardless of bed rest.” Symptoms include sensitivity to light, headaches, joint and muscle pain, fatigue and weakness and tender lymph nodes, among others.

“While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients who, while having recovered from the acute infection, may be suffering from long-term and debilitating COVID-induced chronic fatigue symptoms such as brain fog and disabling and profound post-exertional malaise,” AIM CEO Thomas K. Equels said in a release.

AIM now has the clearance to enroll 100 patients in its trial, with 20 of them being long haulers. Ampligen is currently the sole late-stage drug in the pipeline for chronic fatigue syndrome, and it has already been authorized for use in Argentina.