Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company working to develop new treatments that address critical unmet healthcare problems, announced today that it has got a regulatory permit from the Ministry of Health of North Macedonia to expand the COVAMID clinical investigation of its BentrioTM nasal spray in sick people with acute COVID-19 into the Republic of North Macedonia. North Macedonia is a sovereign state with 2.1 million inhabitants and shares western borders with Bulgaria.
COVAMID is a completely random, placebo-controlled clinical trial designed to assess the potential of Bentrio nasal spray to minimize SARS-CoV-2 viral load in the nose, relieve COVID-19 signs and symptoms, and decrease the occurrence of COVID-19-related hospitalizations. In the COVAMID experiment, 136 COVID-19 patients will be randomly selected in a 2:1:1 ratio to receive Bentrio, a placebo (Bentrio excluding its vital mineral constituent), or no therapeutic interventions for 10 days, preceded by a 10-day monitoring period.
“Expanding our study into North Macedonia solidifies our capacity to achieve our COVAMID testing target,” said Thomas Meyer, founder Chairman and CEO of Altamira Therapeutics. “We are delighted to increase the overall recruitment potential by expanding the number of research sites in conformance with our original plans. We remain hopeful that the COVAMID test will be completed in the third quarter of 2022, assuming there are enough COVID-19 cases.”
In a statement released by the Company last month, it confirmed that it had attained the midpoint of enrollment in its COVAMID clinical study. Altamira will finalize enrollment at 136 or widen it to up to 180 participants depending on a blinded pilot study to evaluate the accuracy of research hypotheses.
Bentrio (AM-301) is a drug-free nasal spray designed to protect the user from airborne viruses and allergens. Bentrio forms a protective gel layer on the nasal mucosa after being applied to the nose. This thin film is intended to stop viruses or allergens from contacting cells; additionally, the composition binds such particles and aids in their emission, as well as humidifying the nasal mucosa. This is intended to lower the risk of upper respiratory tract viral infections while also promoting the relief of allergic symptoms. Bentrio was shown to decrease the infectious viral load in human nasal epithelial cells colonized with SARS-CoV-2 by more than 99 percent when used for mitigation.
Furthermore, when treatment began only 24 or 30 hours after infection, Bentrio was able to slow the rise of the viral titer. A clinical study in a pollen challenge chamber showed a substantial decline in the main symptoms of allergic rhinitis, with the protective effect occurring quickly and lasting for 4 hours.