AIM ImmunoTech Inc (NYSE:AIM) has announced a new provisional patent application for its flagship drug candidate Ampligen as both an intranasal and an intravenous therapy for what the company describes as Post-COVID-19 Cognitive Dysfunction (PCCD).
The Ocala, Florida-based immuno-pharma company has been working steadily to expand its coronavirus (COVID-19) patent portfolio. In addition to the new provisional patent application addressing compositions and methods for treating PCCD, in February 2020 the company filed multiple COVID-19-related provisional patient applications, which are now patent pending worldwide, for Ampligen as a COVID-19 therapy and as a vaccine adjuvant.
“Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the population,” noted the company. The company pointed out that people suffering from PCCD, including some young adults, are afflicted with severe difficulties in “concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks”.
READ: AIM ImmunoTech well positioned with $57.3M to advance clinical trials of flagship drug Ampligen
Early data has demonstrated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program (EAP) have reported improvements in cognitive function, according to Dr Charles Lapp, at Hunter-Hopkins Center, in Charlotte, North Carolina.
“The results of some individual symptoms are very dramatic,” said Lapp, the EAP’s lead investigator. “The results clearly show a significant reduction of one or more symptoms of PCCD in patients after the administration of Ampligen.”
The Wall Street Journal recently reported that intranasal immunity to the SARS-Cov-2 virus may be a key to controlling the spread of COVID-19, especially the more contagious and deadly Delta variant, which can accumulate in nasal tissues even in individuals who have been vaccinated with currently available vaccines.
“AIM’s leadership and scientific experts reached a similar conclusion in the early days of the COVID-19 outbreak, deciding then to make the development of intranasal Ampligen a major R&D goal,” said the company.
“There is a growing and significant need for effective therapies to treat COVID-19, both in the acute phase and its longer-term effects,” AIM CEO Thomas K. Equels said in a statement. “We believe that Ampligen has the potential to activate the body’s innate immune system to fight COVID-19 through its use as a front-line, early-onset therapeutic — which includes potentially reducing intranasal viral load, potentially curbing the spread of the disease and lessening its severity. We believe Ampligen also can play a role in treating Post-COVID-19 Cognitive Dysfunction. PCCD is one of the most common and disabling immediate after-effects of acute COVID-19 infection.”
In early 2021, AIM launched a Phase 1 intranasal safety study of Ampligen, testing the safety and tolerability of Ampligen at increasing doses, in anticipation of testing its potential as an intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. AIM announced in June that there were no severe adverse effects observed in the study at any dosage level.
More recently in July, AIM revealed significant progress toward a Phase 2a Human Challenge Trial to test the intranasal prophylactic effect of Ampligen in separate Rhinovirus hRV and Influenza cohorts. The study is part of AIM’s work to develop Ampligen as a potential therapy against SARS-CoV-2 and other respiratory viruses. The trial is expected to start in the fourth quarter this year.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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