Altamira Therapeutics Ltd. provided an update on the clinical trials with Bentrio® in seasonal allergic rhinitis (SAR) and acute COVID-19. Bentrio nasal spray is intended to help protect against airborne allergens and viruses. An interim analysis based on the accumulated data from the first 53 participants in the NASAR trial showed a statistically significant reduction of nasal symptoms with Bentrio vs.

saline nasal spray comparator as well as good tolerability and safety. The mean reflective Total Nasal Symptom Score (rTNSS) as the primary efficacy endpoint decreased in the Bentrio group from 6.7 points in the pre-treatment period to 5.1 points over the 14-day treatment period, while the saline spray group showed a decrease from 7.6 to 7.1 points. The treatment effect of 1.55 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.015; 95% confidence interval -2.78 to -0.32).

The result is well above the minimal clinically important difference of 0.28 points. The interim analysis further showed good tolerability and safety both for Bentrio and the comparator. For eligibility in the NASAR trial, patients had to rate their rTNSS at 5 points or higher, among meeting other requirements.

The TNSS comprises ratings for nasal congestion, sneezing, nasal itching, and rhinorrhea (runny nose) and has a maximum score of 12 points. Participants were randomized at a 1:1 ratio to either receive Bentrio or saline spray via self-administration three times per day, or as needed. Since the interim analysis confirmed the validity of assumptions for the statistical powering of the study, enrollment into the trial was completed at n = 100, as planned.

The last patient recently completed its last study visit; the results from the complete trial are expected to become available in Second Quarter 2023. Top-line data from the COVAMID trial in 160 patients with current COVID-19 infection show a trend for a more pronounced improvement in the Bentrio treatment groups on the primary efficacy endpoint, the change in PCR cycle threshold (CT), compared with no treatment. The mean increase in the CT value from baseline to Day 11, was 15.3 for the Bentrio group, 14.1 for the modified-Bentrio group and 13.7 for the untreated control group.

An increase in the CT by 1 indicates a decrease in the nasal viral load of 50%. In the mixed model for repeated measures (MMRM) the difference in the mean change of CT values of the Bentrio group vs. the untreated and the modified-Bentrio groups to Day 11 failed to reach statistical significance (LSmeans 0.8 and 0.64; p = 0.319 and 0.427; 95% CI -0.78 to 2.38 and -0.95 to 2.23, respectively).

More Bentrio and modified-Bentrio treated patients achieved full resolution of COVID-19 signs and symptoms by Day 11 than untreated patients (93.7 and 92.5 vs. 85.0%) and more of them were uninfected or asymptomatic at that time point (59.5 and 65.0 vs. 45.0%).

The treatment was well tolerated. The incidence of adverse events in the Bentrio group was 2.4% (mild cases only), 9.5% in the modified-Bentrio group (mild cases only), and 16.3% in the untreated group (all mild, except for 1 moderate case and 2 severe cases /unwitnessed sudden death after Day 11). The COVAMID trial enrolled patients in Bulgaria and North Macedonia suffering from acute COVID-19 (confirmed by positive PCR test) up to 3 days from symptom onset.

They were randomized at a 2:1:1 ratio to receive for 10 days either Bentrio, modified Bentrio (lacking one mineral ingredient) or no treatment, followed by a 10-day observation phase. During the study period, Omicron was the predominant SARS-CoV-2 variant in the population of the study countries. Based on an estimated incubation time of 3 days, participants of the COVAMID trial started treatment on average 4.5 days post infection.