Auris Medical Holding Ltd. (NASDAQ: EARS), 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.
Today they announced additional details on the outcomes from the clinical investigation of its Bentrio nasal spray in allergic rhinitis and provided an update on the regulatory pathway in the US for the intended use in allergy.
BentrioTM 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 BentrioTM 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.
Undertreatment with BentrioTM, 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 BentrioTM 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. BentrioTM 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, BentrioTM 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 US Food and Drug Administration (FDA). Final analyses show a difference of 0.4 points in favor of BentrioTM (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 BentrioTM; with the exception of one case, all study participants rated the tolerability favorably.
Pre-submission meeting with FDA
On 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 BentrioTM 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.
“We are very delighted to have reached further important milestones with our BentrioTM program”, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We are very delighted by the positive outcomes from the pollen chamber study, where BentrioTM provided rapid and effective protection for four hours of challenging allergen exposure. In addition, we very much appreciated the FDA’s feedback during the pre-submission meeting and feel well-positioned to advance the preparations for a 510(k) submission. At the same time, we are on track to meet the essential requirements for marketing the product in Europe under the CE mark shortly. We intend to launch the commercialization of BentrioTM in selected European countries towards the end of June 2021 through various on- and offline distribution channels. Launch preparations are in full swing.”
*BentrioTM (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, BentrioTM forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms.
