Auris Medical provides update on Bentrio program in allergy.

Auris Medical Holding Ltd. a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, and its affiliate Altamira Medica Ltd. announced additional details on the outcomes from the clinical investigation of its Bentrio (formerly AM 301) nasal spray in allergic rhinitis and provided an update on the regulatory pathway in the US for the intended use in allergy. Bentrio effectively alleviates allergy symptoms in clinical pollen challenge: Bentrio was tested in an open-label randomized cross-over trial in 36 patients with allergic rhinitis to grass pollen. Study participants were administered a single dose of Bentrio nasal spray or a comparator product prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge was repeated with the alternate treatment following a wash-out period. The study demonstrated a rapid onset and long durability of Bentrio’s protective effect, established substantial equivalence to the marketed comparator with superior efficacy ratings by patients and clinicians, and showed good tolerability. Under treatment with Bentrio, participants reported a mean increase in the Total Nasal Symptom Score (TNSS; averaged over 4 hours in 20 minute intervals) of 4.75 points, which was 1.11 points and thus significantly below TNSS levels when exposed to pollen without nasal spray protection (ANCOVA least square means; 95% confidence interval, CI: -1.61 to -0.61). A 1-point reduction in the TNSS is considered clinically relevant. 31.4% of study participants rated the efficacy of Bentrio as “good” or “very good”, while study investigators provided such rating for 45.7% of participants. Under treatment with the comparator product, a powder spray based on hydroxypropylmethylcellulose (HMPC), the TNSS increased on average by 5.14 points, which was 0.71 points lower than when unprotected (CI: -1.21 to -0.21). 14.3% of study participants rated the efficacy of the comparator as “good” or “very good”, while study investigators provided such rating for 25.0% of participants. Bentrio showed significantly lower increases in the TNSS than HPMC especially during the early phase of pollen exposure, reaching clinical relevance and suggesting a rapid onset of action. As previously announced, Bentrio met the primary endpoint of substantial equivalence in the change of TNSS relative to HPMC, which serves as a predicate device for the planned 510(k) submission to the FDA. Final analyses show a difference of 0.4 points in favor of Bentrio (CI -0.89 to 0.10), confirming non-inferiority. Proof of substantial equivalence to the predicate device is a key requirement for market clearance in the US under the 510(k) regulatory pathway. In addition, the study provided further evidence for the favorable safety profile of Bentrio; with the exception of one case, all study participants rated the tolerability favorably. n May 6, 2021, Altamira Medica met with the FDA for a pre-submission meeting relating to a 510(k) pre-market notification application. The Company expects to request regulatory clearance for Bentrio for the intended use in allergy under the 510(k) pathway. During the meeting, the Company obtained important information needed to help finalize the submission package. Importantly, the Agency indicated that the design of the pollen challenge study appeared appropriate to support the planned 510(k) submission.