AIM ImmunoTech Inc (NYSE:AIM) announced that its dsRNA product candidate Ampligen (rintatolimod) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of Ebola virus disease.
The company said it was developing Ampligen for globally important cancers, viral diseases, and disorders of the immune system. Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1, AIM said.
AIM CEO Thomas K Equels said receiving Orphan Drug Designation for Ampligen was a testament to the depth and breadth of the drug's potential.
READ: AIM ImmunoTech backed by Delaware Court of Chancery’s decision to deny Activist Group’s takeover bid
“We continue to be encouraged by the promising results Ampligen has demonstrated to date across a number of indications where there remains significant unmet need,” he said.
“While Ebola is not a primary focus for the company at the moment, this provides further validation as well as optionality as we determine the next steps for this program moving forward.”
The FDA grants Orphan Drug Designation to drugs intended for the treatment, prevention or diagnosis of a rare disease or condition and provides sponsors with incentives, including tax credits for qualified trials, exemption from user fees, and potential market exclusivity for seven years after approval.
The company highlighted its current work underway evaluating the safety and effectiveness of intravenous Ampligen to reduce the replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients.
AIM added that it plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.
AIM is 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.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on Twitter @emilyjjarvie