Auris Medical (EARS) Announces Positive Preclinical and Clinical Outcomes with AM-301 and Details Plans for Market Launch

• Clinical evaluation of AM-301 nasal spray in allergic rhinitis meets primary endpoint
• Extended protection achieved over several hours
• Preliminary preclinical data suggest therapeutic utility post SARS-CoV-2 infection
• Product launch under BentrioTM brand in selected European countries towards end of Q2 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 provided an update on its AM-301 program for protection against airborne viruses and allergens.

“We are very pleased to report on major progress with our AM-301 nasal spray program, which is moving in large steps forward towards the start of commercialization”, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “AM-301 has been designed to provide a triple protective effect by acting as a protective layer on the nasal mucosa, trapping and helping to remove airborne particles and through humidification of the mucosa. Fresh preclinical and clinical data confirm AM-301’s protective effects in case of exposure to airborne allergens and suggest potential utility of the product also in case of ongoing infection from SARS-CoV-2. We have numerous additional studies ongoing or planned and look forward to sharing further outcomes, including through scientific communications.”

AM-301 effectively alleviates allergy symptoms in clinical pollen challenge

Altamira Medica recently completed the treatment phase of its open-label randomized cross-over clinical investigation of AM-301 in 36 patients with allergic rhinitis to grass pollen. Study participants were administered a single dose of AM-301 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. Preliminary analyses show that AM-301 met the primary endpoint of non-inferiority in the Total Nasal Symptom Score (TNSS) relative to the marketed comparator product, which serves as the predicate device for the planned 510(k) submission to the US Food and Drug Administration (FDA). In addition, the treatment was well tolerated. Proof of substantial equivalence to the predicate device is a key requirement for market clearance under the 510(k) regulatory pathway.

Furthermore, the allergen challenge study demonstrated a rapid onset and long durability of AM-301’s protective effect, as measured by a clinically relevant 1-point reduction in the TNSS compared to unprotected pollen exposure. On average, the protective effect was maintained for at least three hours. These clinical observations are in line with the results from a new in vitro study based on a barrier diffusion model. The assay, which was performed at 35°C and 90% relative humidity to mimic conditions within the nasal cavity, showed that a thin layer of AM-301 prevented Timothy grass pollen from diffusing into an agar block for up to 6 hours, the maximum duration of the experiment.

AM-301 helps to reduce growth in infectious titer in ongoing SARS-CoV-2 infection

In parallel with the outcomes from the allergy studies, Altamira Medica obtained first data from testing AM-301 after the start of infection of human nasal epithelium cells with SARS-CoV-2. In a previous study in the same type of assay, AM-301 had been shown to be highly effective in reducing the infectious viral titer when daily treatment was started right before inoculation of the cells, i.e. in a preventative fashion. In the new experiment, daily treatment with AM-301 started 24 or 30 hours post inoculation. Saline- and vehicle-treated and untreated cell cultures served as controls.

In control cultures, SARS-CoV-2 replicated efficiently over four days, resulting in a rapid increase in viral titer (as measured by the Median Tissue Culture Infectious Dose, TCID50, in Vero cells). Daily treatment with AM-301 resulted in a statistically significant deceleration of the viral titer growth compared to controls (p-value <0.01, linear mixed-effects model). At Day 4 of the experiment, viral titers were 73.7 to 94.5% lower compared to controls.

Selection of BentrioTM brand name for commercialization

With the ongoing progress in the development and testing of AM-301, the Company expects to meet the essential requirements for marketing the product in Europe under the CE mark shortly. Altamira Medica intends to launch the commercialization of AM-301 under the brand name BentrioTM in selected European countries starting in June 2021, employing various on- and offline distribution channels. The Company expects to expand market coverage rapidly during the second half of 2021, including collaborations with future licensing partners. The expansion will be supported by significant, scalable contract manufacturing capacity.

Upon readiness for CE mark conformity, Altamira Medica expects to submit a 510(k) pre-market notification application to the FDA requesting regulatory clearance for AM-301 for the intended use in allergy. Regarding the intended use in viral infections, the Company continues to be engaged in a dialogue with the FDA on the applicable regulatory pathway.

Conference Call & Webcast

Auris Medical's management team will host a live conference call and webcast to present a business update on the AM-301 program at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-877-870-9135 (US, toll free) or +44-2071-928-338 (international), and enter passcode 5649276. A live webcast of the conference call can be accessed in the Investor Relations section of the Auris Medical website at www.aurismedical.com. A replay will be available approximately two hours following the live call.

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