Altamira Medica

Protection against airborne allergens and viruses

Development status

Development of Bentrio™ (AM-301) has been completed. The product has been introduced to the market, starting in selected countries of the European Union.

Overview of key studies

StudyStudy designStatus
SARS-CoV-2 protection in human nasal epithelium model for Alpha and Delta variants

Daily treatment with Bentrio™ for 4 days starting 10 minutes prior to inoculation

Completed
SARS-CoV-2 treatment in human nasal epithelium model for Alpha and Delta variants

Daily treatment with Bentrio™ for 4 days starting 24 or 30 hours after inoculation

Completed
Prevention / treatment of H1N1 infection in human nasal epithelium model

Daily treatment with Bentrio™ for 4 days starting after inoculation

Completed
Protection against symptoms of allergic rhinitis under grass pollen challenge

Exposure of patients with history of allergic rhinitis to grass pollen for four hours, treated prior with either Bentrio™ or HPMC powder nasal spray (n=36)

Completed
Protection against symptoms of seasonal allergic rhinitis (SAS) - NASAR trail

SAR patients to self-administer Bentrio™ or saline control 3 times a day or, as needed, for 2 weeks (n=100)

Ongoing
Prevention / treatment of SARS-CoV-2

Treatment of patients with confirmed Covid-19 and non-infected household members with Bentrio™ or placebo (n=592)

Planned

Preclinical and clinical evidence

Preventive use of Bentrio™ reduces SARS-CoV-2 titer by up to 99.4% and 83% for the Alpha and Delta variants, respectively.

Mean viral titer in Vero cells over four days following inoculation of human nasal epithelium model with SARS-CoV-2. Treatment with saline solution (control), AM-301 (Bentrio™) or AM-301 without key component (matrix) started 10 minutes prior to inoculation and continued once daily. Compared to the saline control group, Bentrio™ achieved a reduction in viral titer of >99% for the Alpha and 83% for the Delta variants on Days 3 and 4.

Bentrio™ reduces SARS-CoV-2 titer by up to 92% and 69-85% for the Alpha and Delta variants, respectively, when applied on an already ongoing infection (i.e. used as a treatment).

Mean viral titer in Vero cells over four days following inoculation of human nasal epithelium model with SARS-CoV-2. Treatment with saline solution (control), AM-301 (Bentrio™) or AM-301 without key component (matrix) started 24 hours after inoculation and continued once daily for 4 days. Compared to the saline control group, Bentrio™ achieved a reduction in viral titer of >92% on Day 4 for the Alpha variant and 69 and 83% on days 3 and 4, respectively, for the Delat variant.

Bentrio™ alleviates allergic rhinitis symptoms.

Mean change in the Total Nasal Symptom Score (TNSS) during stay of study participants with history of allergic rhinitis in grass pollen challenge chamber. A single dose of Bentrio™ applied into each nostril  prior to entering the chamber provided for a significant reduction in the self-rated TNSS. 

Current clinical investigations

The NASAR trial, initiated in December 2021, is being conducted during the current pollen season at several study sites in Australia. The trial, which will enroll a total of 100 SAR patients, is designed to compare the safety and efficacy of Bentrio™ against a saline nasal spray.

© Altamira Therapeutics

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