Thomas Meyer: Thank you, Cova. Now let’s discuss our legacy assets, the Bentrio drug-free nasal spray and our AM-125 betahistine nasal spray for vertigo. In the month of May, we shared exciting findings from the randomized controlled NASAR clinical trial, evaluating Bentrio nasal spray in patients with seasonal allergic rhinitis, short SAR. To study the efficacy of Bentrio, there’s a NASAR trial enrolled 100 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 3 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, which is 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 two-week treatment period between Bentrio and saline nasal spray, which is the current standard of care when it comes to drug-free allergic rhinitis management. The NASAR results demonstrated for Bentrio a statistically significant and highly relevant clinical improvement in efficacy over saline nasal spray. The improvement from baseline was 1.9 points in the rTNSS, which was 1.1 points or 2.4 fold larger than saline. Both outcomes came in well above the minimal clinically important difference of 0.28 points. 63% of Bentrio-treated study participants rate treatment efficacy is very good or good compared to just 29% of saline spray users. Whereas a saline nasal spray aims to rinse-out allergen articles, Bentrio forms a thin protective layer, which prevents contact of those particles with the nasal mucosa and helps to remove them through natural mucociliary clearance.
As already demonstrated in a previous trial, Bentrio stays for about 3.5 hours within the nasal cavity where it can exert its protective effects. In contrast, saline sprays present for only about 1 hour and provides narrow distribution and less coverage within the cavity. We expect to release further results from the NASAR trial shortly and to submit an article for publication in a peer-reviewed medical journal. The data readout from the NASAR trial completes the Bentrio development program in allergic rhinitis. Previous clinical trials demonstrated already safety, tolerability and the efficacy of Bentrio in patients exposed to grass pollen or house dust mites under controlled conditions and the extended nasal residence time of more than 3 hours in human volunteers.
The accumulated data suggests that Bentrio based on a drug-free and preservative-free formulation can help to effectively reduce the most common symptoms of allergic rhinitis. The reduction of symptoms was similar to that observed in response to medicated nasal sprays, but without the tolerability issues, frequently experienced with the use of such sprays. In July, we announced an exclusive agreement with Pharma Nordic for the marketing and distribution of Bentrio in Norway and potentially for the Scandinavian countries. The collaboration agreement will allow Pharma Nordic to market and commercialize Bentrio in Norway, beginning in the first quarter of 2024 and subject to meeting certain milestones also in Sweden, Finland and Denmark later on.
We look forward to building Bentrio together with Pharma Nordic into one of the leading brands for allergic rhinitis management in Scandinavia. Discussions with potential marketing and distribution partners for the U.S. and other key markets have continued to move forward and are still ongoing at this time. In the context of these partnering discussions, we have made the decision to suspend preparations for launching Bentrio in the U.S. on its own and minimize marketing and sales activities in Europe, as previously communicated. It’s worth noting that in 2023, the U.S. sales of over the counter allergy remedies are estimated to reach close to $4 billion, representing a major opportunity in a non-medicated preservative-free treatment category.
