Bentrio™ formulation well tolerated in vitro on human nasal epithelium
Up to 99% reduction of SARS-CoV-2 viral titer with prophylactic treatment vs. controls
Viral titer reduced 12- or 14-fold vs. controls when treatment started 24 or 30 h post infection
Hamilton, Bermuda, July 14, 2021 – Auris Medical Holding Ltd. (NASDAQ: EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced additional preclinical data in a model of primary human nasal airway epithelium from its Bentrio™ (AM-301) nasal spray development program in SARS-CoV-2. AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental models of prophylaxis and mitigation. The manuscript describing these preclinical data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2021.07.12.452021v1 and will undergo scientific peer-review for potential publication.
“These data provide strong evidence for Bentrio’s potential to help reduce the risk of SARS-CoV-2 infection of human mucosal cells when used preventatively and to decelerate its course when used shortly after its onset“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Recently published clinical data from an independent research group show that targeting the nasal mucosa during the early stage of Covid-19 is an ideal strategy for preventing the propagation of SARS-CoV-2.1 We look forward to the imminent start of the market roll-out of our Bentrio nasal spray to help address this current pandemic with a novel drug-free means for self-protection.”
The preclinical studies were performed in a well-established model of reconstituted nasal epithelium from human donors (MucilAir™), which provides testing conditions that tend to be more challenging than real-life conditions in the human nose. AM-301 was studied to determine its compatibility with MucilAir™, its efficacy in preventing MucilAir™ from being infected by SARS-CoV-2, and its ability to mitigate an established infection in MucilAir™ without any previous treatment. First, AM-301 had no detrimental effects on MucilAir™ inserts despite repeated application over 4 days: measures of tight junction integrity and cytotoxicity support Bentrio’s safety and did not show any significant difference between treated and control cultures. An expected finding was that the ciliary beat frequency was slightly reduced due to the viscosity of the formulation.
Prophylactic treatment with AM-301 was protective against SARS-CoV-2 infection, as daily application of the product starting 10 minutes prior to inoculation led to a 2-log (99%) reduction in viral titer (Tissue Culture Infectious Dose; TCID50) by Day 4 compared to controls. Inserts that received the product daily, starting 24 or 30 h after viral infection, also had a lower viral titer, corresponding to a 12- or 14-fold lower TCID50 at the end of the treatment. In a linear-effects mixed model with log-transformed data, the time profile of SARS-CoV-2 infection was significantly decelerated compared to controls both in case of prophylactic treatment (t=5.49; p<0.001) and in case of mitigation treatment starting 24 or 30 h post infection (t=3.68; p<0.01).
As recently announced, Auris Medical’s affiliate Altamira Medica Ltd. will start the market roll-out of Bentrio™ by launching it in Germany. Bentrio™ will shortly become available through selected online pharmacies; over the coming months, market coverage will be expanded progressively through additional distribution channels and in further countries.
Bentrio™ (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio™ 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. In human nasal epithelium cells infected by SARS-CoV-2, Bentrio™ was shown to reduce the infectious viral load by more than 99% when used for prevention. Further, Bentrio™ was effective in slowing the growth of the viral titer when treatment started only 24 or 30 hours after infection. In allergy, a clinical investigation in a pollen challenge chamber demonstrated a significant reduction in the main symptoms of allergic rhinitis with the protective effect setting in rapidly and lasting for 4 hours.
About Auris Medical
Auris Medical is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore™ / SemaPhore™ platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio™; pre-commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen® and Sonsuvi®, Phase 3). 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.” The Company will change its name to “Altamira Therapeutics Ltd.” and its ticker symbol to “CYTO”, subject to approval by a Special General Meeting of shareholders to be held on July 21, 2021.
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.
1 Ahn JH et al. (2021), Nasal ciliated cells are primary targets for SARS-CoV-2 replication in the early stage of COVID-19, J Clin Invest. 131(13):e148517.