Protective gel from nasal spray reduces seasonal allergic rhinitis symptoms

Key takeaways:

• Bentrio forms a gel that shields nasal cells against airborne allergens and viruses.
• The Bentrio group saw greater improvements in quality-of-life scores than the saline spray group.

Designed for over-the-counter use, the Bentrio nasal spray from Altamira Therapeutics was more effective in treating nasal symptoms in seasonal allergic rhinitis than saline solution, according to a press release from the company.

Upon application, Bentrio forms a protective and drug-free layer of gel on nasal mucosa, preventing airborne allergens such as pollen, house dust mites and animal dander as well as virus particles from contacting cells for approximately 3.5 hours.

“The main inspiration came from nature, considering how our nasal mucosa helps to defend the body when incredible numbers of harmful airborne particles are inhaled,” Thomas Meyer, PhD, CEO of Altamira Therapeutics, told Healio.

The composition also binds these particles and assists in their discharge, in addition to humidifying the nasal mucosa, alleviating allergic symptoms and mitigating viral infections in the upper respiratory tract, Altamira Therapeutics said.

Thomas Meyer

“We wanted to strengthen that defense by applying a thin protective film on top to act as a barrier, capture airborne particles and aid with their clearance from the nose — a triple effect,” Meyer said.

For example, Meyer explained, inhaled grass pollen would become trapped in the gel without reaching mucosal cells or triggering an allergic reaction. The pollen would then be cleared from the body via the digestive tract.

“Importantly, we wanted to achieve this with a nasal spray free of any active pharmaceutical ingredient and preservatives for good tolerability,” Meyer said.

Study design, results

During the NASAR trial, 100 patients with seasonal allergic rhinitis (SAR) self-treated with Bentrio or saline nasal spray at a 1:1 ratio three times a day or as needed for 2 weeks.

“Unlike previous studies with Bentrio, which had exposed patients to allergens for just a few hours under controlled conditions in so-called challenge chambers, NASAR was the first study conducted under real-life conditions with treatment over 14 days,” Meyer said.

These patients all had reflective Total Nasal Symptom Scores (rTNSS) of at least 5 out of 12, indicating worse level of symptoms, during a treatment-free week-long run-in period. Their average rTNSS was 6.9, which the researchers called moderate.

Mean rTNSS scores after 2 weeks included 5 for the Bentrio group and 6.1 for the saline spray group, which equated to a statistically significant 1.1 point (95% CI, –2 to –0.2) difference, meeting the study’s primary efficacy endpoint. This 2.4 times-larger reduction in nasal symptoms compared with the saline spray was clinically relevant, according to the researchers.

Similarly, mean instantaneous TNSS scores fell from 4.4 at baseline to 2.9 at the end of treatment for the Bentrio group and from 4.8 to 3.7 for the saline spray group, which was a significant difference of 0.8 points (95% CI, –1.6 to –0.04).

Bentrio’s effect on the four nasal symptoms covered by the TNSS — nasal congestion, runny nose, nasal itching and sneezing — were apparent on the first day of the treatment period, according to the press release, particularly among patients whose symptoms were considered moderate to severe.

The Bentrio group also experienced improvements in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, from a mean total of 3 at baseline to 1.7 at day 14, compared to the fall from 2.8 to 2.4 in the saline spray group. This was a statistically significant and clinically relevant difference in improvement of 0.7 points (95% CI, –1.1 to –0.31).

The patients in the Bentrio group saw significantly superior improvements in each of the eight items on the RQLQ compared with the saline spray group, by factors of 1.8 to 3.7, according to data from Altamira Therapeutics, including nasal, eye and non-nose/eye symptoms, activity limitations, sleep and practical problems and emotional function.

Bentrio reduced the need for cetirizine nasal spray rescue medication as well, the researchers continued, as 11 of 16 (68.7%) of the Bentrio group and four of 15 (26.6%) of the saline spray group abstained from using it during the treatment period. Overall, 20.8% of the Bentrio group and 31.9% of the saline spray group required relief medication.

When asked to rate the tolerability of their treatment, 73.5% of the Bentrio group and 85.5% of the saline spray group called it good or very good. However, 10.4% of the saline spray group and 6.1% of the Bentrio group called their treatment tolerability poor.

Adverse events impacted 42.9% of the Bentrio group and 32.7% of the saline spray group, with most events considered mild and unrelated to treatment, according to the press release.

Conclusions, next steps

“Overall, the results provide great validation of our concept and show the benefit of protecting the nasal mucosa,” Meyer said. “Unlike seawater sprays, which are essentially used to rinse the nasal cavity and are quickly gone, the protective film remains for more than 3 hours in place.”

Altamira Therapeutics is now preparing a manuscript describing the NASAR trial and its findings for submission to a peer-reviewed medical journal.

“With the trial, we have essentially concluded the clinical evaluation of Bentrio,” Meyer said. “In a total of four studies, we have demonstrated the product’s broad coverage of the nasal cavity and extended nasal residence time.”

These studies also confirmed the spray’s efficacy, safety and tolerability in both seasonal and perennial allergic rhinitis, Meyer continued. Also, Meyer said, the FDA already has cleared Bentrio for use in alleviating mild allergic symptoms.

“For commercialization, we believe that the product’s great potential will be developed best in the hands of a well-established OTC consumer health company with a strong footprint in the allergy market,” Meyer said. “Partnering discussions are already well advanced.”

Reference:

• Altamira Therapeutics. Bentrio for protection against airborne allergens. (company backgrounder)