Hamilton, Bermuda, January 29, 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, today announced with its affiliate Altamira Medica AG the initiation of a clinical investigation of AM-301 in allergic rhinitis.
The clinical investigation is an open-label randomized cross-over study that will enroll 36 patients with allergic rhinitis to grass pollen. Study participants will be administered a single dose of AM-301 nasal spray or a comparator product (one puff into each nostril) prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge will be repeated with the alternate treatment following a wash-out period. The difference in the Total Nasal Symptom Score (TNSS) between the two treatments over the 4-hour exposure will serve as the primary efficacy endpoint; the investigation shall demonstrate clinical non-inferiority of AM-301 to the comparator product.
“We are very excited to initiate the clinical investigation of AM-301 for its intended use of alleviating allergic symptoms triggered by inhalation of airborne allergens,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Allergic rhinitis from exposure to allergens such as pollen, house dust or animal hair is affecting 7.8% of the adult US population and 9% of children and can have a major impact on well-being and quality of life. Despite its high prevalence, there is still no cure for it. With AM-301, we are seeking to provide a simple, drug-free and yet effective means for protection of the nasal mucosa against airborne allergens.”
Results from the allergen challenge chamber study are expected in Q2 2021. Beside the development of AM-301 for use in allergy management, Altamira Medica is advancing the testing of the nasal spray for use in the protection against infections from airborne viruses such as SARS-CoV-2.
“Like all of us in the past few weeks, we have been watching with growing concern the spreading of various SARS-CoV-2 mutations around the world,” stated Thomas Meyer. “Given AM-301’s mode of action and inherent broad spectrum, we are confident that the nasal spray will exert protective effects also in case of the new strains. For confirmation, we are planning to test AM-301 against them in reconstituted human nasal epithelia cells shortly.” The Company maintains its objective of introducing AM-301 in selected markets in late Q2 2021.
About AM-301
AM-301 is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, AM-301 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. Together, this is designed to reduce the risk of upper respiratory 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 (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, Auris Medical’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the ability to pursue strategic partnering and non-dilutive funding for its Phase 3 programs, the results of Auris Medical’s review of strategic options and the outcome of any action taken as a result of such review, 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, 2019, 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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