Altamira Therapeutics Reports Positive Top-Line Data from Bentrio Clinical Trial in Seasonal Allergic Rhinitis

• Bentrio® meets primary efficacy endpoint in NASAR clinical trial in seasonal allergic rhinitis
• Clinically relevant and statistically significant improvement in Total Nasal Symptom Score over saline nasal spray control (p = 0.012)
• Bentrio efficacy and tolerability rated as "good" or "very good" by 63.5% and 73.5% of study participants
• NASAR concludes Altamira's clinical development program for Bentrio in allergic rhinitis

HAMILTON, BERMUDA / ACCESSWIRE / May 24, 2023 / Altamira Therapeutics Ltd. (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced positive and statistically significant top-line results from the randomized controlled NASAR clinical trial evaluating its Bentrio nasal spray in patients with seasonal allergic rhinitis (SAR). Bentrio nasal spray is formulated as a drug-free and preservative-free gel emulsion designed to help protect against airborne allergens such as pollen or house dust mites.

The NASAR trial enrolled 100 SAR patients in Australia who were randomized at a 1:1 ratio to receive either Bentrio or saline nasal spray for two weeks via self-administration three times per day, or as needed. For eligibility, patients had to have a baseline reflective Total Nasal Symptom Score (rTNSS) of at least 5 points out of 12, referring to the worst level of nasal congestion, sneezing, nasal itching, and rhinorrhea (runny nose) within the past 24 hours averaged over a one-week treatment-free run-in period. The primary efficacy endpoint was defined as the difference in the average rTNSS over the subsequent 2-week treatment period between Bentrio and saline nasal spray, the current standard of care in drug-free SAR management. The change in mean rTNSS over two weeks is generally accepted as a primary efficacy endpoint for SAR trials and is also recommended by the FDA.

Foto: Accesswire

Graph above compares reduction in mean reflective Total Nasal Symptom Score (rTNSS) with Bentrio vs. saline nasal spray control over two weeks of treatment from baseline

The rTNSS decreased in the Bentrio group from 6.9 points in the pre-treatment period to an average of 5.0 points over the 14-day treatment period (i.e. -1.9 points), while the saline spray group showed a decrease from 6.9 to 6.2 points (i.e. -0.8 points) (see ‘Mean rTNSS' graph). The reduction in nasal symptoms conferred by Bentrio was thus 2.5 times larger than with saline nasal spray. The difference in rTNSS reduction of 1.1 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.012; 95% confidence interval -2.0 to -0.3), and the study thus met the primary efficacy endpoint.