Auris Medical Starts Preparations for Covid-19 Trial with Bentrio in India

Rhea-AI Summary

Auris Medical Holding Ltd. (NASDAQ: EARS) announced that its affiliate Altamira Medica is set to conduct a study in India to evaluate its Bentrio^TM nasal spray's efficacy against airborne viruses and allergens, including Covid-19. The study will begin recruitment in Q3 2021, pending regulatory approvals. Thomas Meyer, CEO, highlighted Bentrio's effectiveness in preliminary studies, emphasizing the ongoing health risks posed by Covid-19 variants. Auris Medical focuses on developing therapeutics in neurotology, rhinology, and allergies, with several product candidates currently in trials.

Positive

• Initiation of a clinical study for Bentrio^TM nasal spray may enhance its market presence.
• Bentrio^TM has shown promising efficacy against SARS-CoV-2 in preliminary studies.

Negative

• The study's success depends heavily on regulatory and ethics committee approval.
• Ongoing health risks from Covid-19 variants may hinder market acceptance.

Hamilton, Bermuda, June 1, 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 allergology, today announced that its affiliate Altamira Medica Ltd. has started preparations for the conduct of a study with its Bentrio^TM nasal spray for protection against airborne viruses and allergens in India. The study will seek to evaluate the efficacy of Bentrio^TM in the prevention and treatment of acute Covid-19 and shall start recruitment in the third quarter 2021 subject to regulatory and ethics committee approval.

“In our studies in human nasal epithelium cells, Bentrio has shown to be highly effective both in protecting against SARS-CoV-2 when applied before infection onset and in reducing infectiousness when applied afterwards”, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We now look forward to testing and confirming Bentrio’s efficacy also clinically. Despite great progress with vaccination programs, Covid-19 remains a major health risk and concern for many people and many countries worldwide, as evidenced by recent surges in infection rates and the continued emergence of virus variants.”

About Bentrio^TM

Bentrio^TM (AM-301) is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio^TM 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 Bentrio^TM (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.

Investor contact:

investors@aurismedical.com     

FAQ

What is the purpose of the Bentrio^TM nasal spray study announced by Auris Medical (EARS)?

The study aims to evaluate the efficacy of Bentrio^TM in preventing and treating acute Covid-19 and other airborne viruses and allergens.

When will the Bentrio^TM study recruitment start?

Recruitment for the study is expected to begin in the third quarter of 2021, subject to regulatory approvals.

What are the preliminary findings related to Bentrio^TM?

Preliminary studies suggest Bentrio^TM is effective in protecting against SARS-CoV-2 when applied before exposure and in reducing infectiousness afterwards.

What is the focus of Auris Medical (EARS) in terms of product development?

Auris Medical is focused on developing therapeutics for neurotology, rhinology, allergies, and CNS disorders.

What are the risks associated with the Bentrio^TM study for Auris Medical (EARS)?

The success of the study is contingent on obtaining timely regulatory and ethics committee approvals, which pose significant risks.