Altamira Therapeutics files Bentrio 510(k) for allergy indication

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Altamira Therapeutics’ (NASDAQ:CYTO) Bentrio is an OTC nasal spray that is drug- and preservative-free and designed to provide triple protection against airborne viruses and allergens. First, it helps to protect the nasal mucosa by acting as physical barrier. Second, it traps airborne particles via electrostatic effects. And third, Bentrio humidifies the nasal mucosa, thus aiding its functionality as the body’s natural defense against airborne particles. Importantly, Bentrio’s proprietary gel formulation allows for an extended residence time within the nose, to provide protection for at least three hours. 

Altamira announced that it has submitted a 510(k) premarket notification with the FDA for Bentrio for the treatment of hay fever and allergy by promoting protection against airborne viruses and alergens.

These include indoor and outdoor environmental pollens, house dust, animal hair and dust mites. Once cleared, the company anticipates partnering Bentrio for the U.S. market rather than commercializing on its own.

Bentrio has been launched in Germany under CE Mark in late July and subsequently in Austria. 

The primary focus of Altamira’s current Bentrio marketing campaign in Europe is on the need for extra protection against SARS-CoV-2. 

During the initial launch stage, Bentrio has been marketed solely through leading online pharmacies, supported by digital campaigns. Promotional activities now are being expanded to further European countries. In the next phase of the European launch of Bentrio, the company also will target traditional brick-and-mortar pharmacy stores. starting in the fourth quarter of 2021.

In international markets, Altamira recently executed letters of understanding with distributors in two key Southeast Asian countries, with national registrations being initiated. Based on a growing number of leads and strong interest in the product, Altamira expects to expand the geographic footprint for Bentrio rapidly through agreements with additional distributors.

The company also is advancing its clinical development programs for Bentrio. In allergy, two studies are moving through the approval process: one for house dust allergy as a challenge study, and another for seasonal allergic rhinitis. These studies will be conducted in Canada and Australia, with data read-outs expected for the first half of 2022. 

In viral infection, Altamira is awaiting approval of a placebo-controlled COVID-19 study by the Drugs Controller General of India.

“While we have been making significant progress in all of our development programs, in many ways, we just recently crossed the starting line, with the European launch of Bentrio marking our transition to a commercial-stage company,” Thomas Meyer, founder, chairman and CEO of Altamira, said in a statement. 

“Now, based on the early success we are seeing in Germany, our focus for the product will be on both geographic and treatment market expansion,” Mr. Meyer added.