- BentrioTM meets primary efficacy endpoint in clinical evaluation in allergic rhinitis
- Clinically relevant and significant reduction in nasal symptoms
- Superior efficacy ratings by patients and clinicians
- Pre-submission meeting with FDA supports 510(k) regulatory pathway
Hamilton, Bermuda, May 7, 2021 – 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 announced additional details on the outcomes from the clinical investigation of its BentrioTM 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
BentrioTM 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.
Under treatment 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.”
About BentrioTM
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.
About Auris Medical
Auris Medical is a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders. The Company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125, in Phase 2) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201, post Phase 1b). Through its affiliate Altamira Medica, the Company is developing a nasal spray for protection against airborne viruses and allergens BentrioTM (AM-301). In addition, Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”
Forward-looking Statements
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may”, “might”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “projects”, “potential”, “outlook” or “continue”, or the negative of these terms or other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval and timing of commercialization of AM-301, Auris Medical’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F for the year ended December 31, 2020, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
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