KIRKLAND, Wash.–(BUSINESS WIRE)–Amcyte Pharma, a Seattle-based company dedicated to the commercialization of immunomodulators, announced the results of an independent clinical trial among ICU staff suggesting that its product, NasitrolTM nasal spray, represents a safe and effective treatment that could prevent transmission of COVID-19. Amcyte will market Nasitrol in the U.S. through a licensing agreement from Laboratorio Pablo Cassara, an Argentinean pharma company leader in innovation.
Nasitrol is a patented nasal spray based on iota carrageenan, a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as a nasal spray in the treatment of the common cold. A previous study at the University of Tennessee Health Science Center found that the iota carrageenan formulation inhibits infection by SARS-CoV-2, the virus that causes COVID-19, in cell culture in vitro.
The current study was conducted at 8 hospital ICUs with a sample of 394 clinically healthy physicians, nurses and other medical professionals who provided care to COVID patients and who had not yet been vaccinated against the disease. Study subjects were randomly assigned to receive four daily doses of Nasitrol spray or placebo for 21 days. The primary end point was clinical COVID-19 infection, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The incidence of COVID-19 infection was significantly lower in the Nasitrol group compared with placebo (1.0% vs 5.0%). There were no differences in the incidence of adverse events between the two groups.
The study was led by Dr. Juan M. Figueroa of The Cesar Milstein Research Institute in Argentina and Dr. Mónica Lombardo of the CEMIC University Hospital in Buenos Aires, and sponsored by the Ministry of Science, Technology and Innovation of Argentina.
“This rigorous, placebo-controlled study provides evidence that the simple intervention of a nasal spray with iota-carrageenan, in addition to hand hygiene, use of personal protective equipment and social distancing, could provide additional protection against transmission,” said Dr. Gustavo Mahler, CEO of Amcyte Pharma. “We look forward to partnering and commercializing Nasitrol in the U.S. so that healthcare professionals, caregivers for COVID patients and other individuals who are at risk can benefit.”
The nasal cavity and the rhinopharynx are key sites of the initial replication of SARS-CoV-2. Iota-carrageenan is thought to exert antiviral activity through its interaction with the viral surface, preventing viral entry and capturing viral particles released by infected cells. The Nasitrol formulation is designed to reduce the viral load in upper respiratory airways, preventing viruses from proliferating and spreading into the lungs. The safety of Nasitrol has been well established and the product has been approved by The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica of the Argentine Republic and commercialized by Laboratorio Pablo Cassara for the prevention of common cold for a decade.
About Amcyte Pharma
Amcyte’s team has over 20 years of experience in cytokine and immunomodulator development and manufacturing. The company has built strong partnerships with leading academic institutions and clinical groups to develop novel indications for its portfolio of products. Amcyte’s pipeline includes cytokines and immunomodulators that enhance the activity of new cell therapy treatments as well as targets for orphan diseases with affordable and improved therapeutic profiles against existing treatments. For more information, please visit www.amcytepharma.com.