Altamira Medica

Protection against airborne allergens and viruses

Bentrio™ was introduced to the market in 2021, starting in selected countries of the European Union.

Overview of key studies

StudyStudy designStatus
SARS-CoV-2 protection in human nasal epithelium model with original virus and Delta and Omicron variants

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

Completed
SARS-CoV-2 treatment in human nasal epithelium model with original virus, and Delta and Omicron variants

Daily treatment with Bentrio™ for 4 days starting 24 or 30 hours after inoculation (for original virus) and 24 hours after inoculation (for Delta and Omicron)

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

Daily treatment with Bentrio™ for 4 days starting 10 min prior to inoculation (prevention) or 24 hours after inoculation (treatment)

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

Daily treatment with Bentrio™ for 4 days starting 10 min prior to inoculation (prevention) or 12 hours after inoculation (treatment)

Ongoing
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
Assessment of the nasal residence time

Single exposure of healthy volunteers with fluoresceine stained Bentrio™ or control (n=12)

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

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

Ongoing
Protection against symptoms of allergic rhinitis under house dust mite (HDM) exposure

Exposure of patients with history of perennial allergic rhinitis to house dust mite allergen for 3 hours, treated prior with 1 spray or 2 sprays of Bentrio per nostril or without treatment (n=36)

Ongoing
Treatment of SARS-CoV-2 - COVAMID trial

Treatment of patients with confirmed Covid-19 with Bentrio™, placebo or no treatment (n=136)

Ongoing

Preclinical and clinical evidence

Preventive use of Bentrio™ reduces SARS-CoV-2 titer by up to 99.4%, 83% and 89.5% for the original virus and Delta and Omicron 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 original virus and 83% for the Delta variants on Days 3 and 4. For the Omicron variant, Bentrio™ achieved a maximal effect at the beginning of the treatment period (day 1), reaching 89.5% reduction in the viral titer compared to the saline control group.

Bentrio™ reduces SARS-CoV-2 titer by up to 92%, 69-85% and 73-87.1% for the original virus and Delta and Omicron 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 original virus and 69 and 83% on days 3 and 4, respectively, for the Delta variant. For the Omicron variant, Bentrio™ achieved a maximal effect on days 2 and 3 of the treatment period, reaching 73 and 87.1% reduction in the viral titer (respectively), compared to the saline control group.

Bentrio™ reduces H1N1 titer by up to 83.9% when applied 10 min before viral infection (i.e. used for prevention) and by up to 77.1% when applied on an already ongoing infection (i.e. used for treatment).

Mean viral titer in Vero cells over four days following inoculation of human nasal epithelium model with H1N1 virus. 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. At the end of the treatment period (i.e. day 4), Bentrio™ achieved a reduction in viral titer of 83.9% when applied 10 min before viral infection (i.e. prevention) and of 77.1% when applied 24 hours after infection (i.e. treatment).

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

Three clinical trials with Bentrio™ enrolling patients suffering from allergies due to airborne allergens are currently ongoing. The NASAR trial, initiated in December 2021, is being conducted 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. The second trial will enroll 36 patients suffering from perennial allergic rhinitis due to house dust mite exposure. In March 2022 we started the COVAMID study evaluating Bentrio™ in the treatment of Covid-19 patients. COVAMID is a randomized, placebo controlled clinical trial to investigate 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.

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