OTC nasal spray being tested against Covid-19
Bermudian-headquartered Altamira Therapeutics Ltd has reached its extended enrolment target of 160 confirmed subjects in its Covamid clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio nasal spray in patients with acute Covid-19.
Bentrio is an over the counter drug-free nasal spray designed for protection against airborne viruses and allergens.
It is being marketed in several countries throughout Europe and Asia to help protect against allergic rhinitis and, where approved, against viral infection.
Recently, Bentrio was cleared in the US for over the counter marketing for the treatment of allergic rhinitis. It is expected to become available in progressively more countries through a growing global network of distributors.
The company said Covamid is a randomised, placebo controlled clinical trial to evaluate the ability of Bentrio nasal spray to reduce the SARS-CoV-2 viral load in the nose, alleviate Covid-19 signs and symptoms, and decrease the frequency of Covid-19 related hospital admissions.
In the trial, the Covid-19 patients are randomised at a 2:1:1 ratio to receive for 10 days either Bentrio, a placebo (Bentrio minus its key mineral component), or no treatment, followed by a 10-day observation phase.
Covamid is being conducted in Bulgaria and North Macedonia.
Following a blinded interim analysis, the company in early August announced that the size of the Covamid study population would be increased from 136 to 160 patients to ensure adequate statistical power.
Altamira expects to announce top-line data from the Covamid trial during the fourth quarter of the year.
With a positive outcome from the Covamid clinical trial, the company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data.
So far, it said, Altamira has demonstrated that Bentrio provides effective protection from infection with human rhinovirus (common cold), influenza virus and SARS-CoV-2 in cell cultures with human nasal epithelia cells.
“We are glad to have swiftly completed the additional patient enrolment for Covamid,” said Jean Lachance, head of Altamira’s OTC consumer health business unit.
“Based on the compelling results which we already achieved with Bentrio in several SARS-CoV-2 assays, we are confident to see the protective effects confirmed also in a clinical setting.
“We consider Bentrio well-positioned to help protect people in a world with manifold and growing exposures to airborne viruses -- for which Covid-19 has dramatically raised consumer awareness.”
Founded in 2003, Altamira is headquartered in Hamilton, with its main operations in Basel, Switzerland.