EARS Auris Medical Holding Ltd.

2.64
-0.18  -6%
Previous Close 2.82
Open 2.84
52 Week Low 0.65
52 Week High 6.6
Market Cap $18,716,312
Shares 7,089,512
Float 1,564,182
Enterprise Value $-2,552,569
Volume 647,175
Av. Daily Volume 7,674,003
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Drug Pipeline

Drug Stage Notes
AM-125
Vertigo
Phase 2
Phase 2
Phase 2 Part B initiation announced October 13, 2020 with enrollment to be completed 1Q 2021.
AM-201
Healthy volunteers
Phase 1b
Phase 1b
Phase 1b data released May 26, 2020. Phase 2 trial planned.
Keyzilen (AM-101)
Acute inner ear tinnitus
Phase 3
Phase 3
Phase 3 data released March 13, 2018 - primary endpoint not met. Noted April 25, 2019 that it intends to discuss a new Phase 2/3 trial with the FDA.
AM-101 (Keyzilen) - TACTT2
Acute inner ear tinnitus
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoints
AM-111 REACH
Surgery-induced hearing loss
Phase 2
Phase 2
Phase 2 trial (REACH) enrollment pending funding.
AM-111 ASSENT
Acute inner ear hearing loss
Phase 3
Phase 3
Phase 3 ASSENT trial terminated - November 28, 2017.
AM-111 HEALOS
Acute inner ear hearing loss
Phase 3
Phase 3
Phase 3 HEALOS trial did not meet primary endpoint - November 28, 2017.

Latest News

    • Net cash inflow of $13.4 million from recent registered direct offering and warrant exercises  
    • AM-301 program progressing towards clinical and regulatory milestones 
    • Strategy review ongoing 

    Hamilton, Bermuda, December 15, 2020 – 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 provided a business update related to the Company's funding position, its AM-301 program for the protection against airborne pathogens and allergens and the ongoing strategy review process.

    Significant change in funding position

    On December 2, 2020, the Company entered into securities purchase agreements with…

    • Net cash inflow of $13.4 million from recent registered direct offering and warrant exercises  
    • AM-301 program progressing towards clinical and regulatory milestones 
    • Strategy review ongoing 

    Hamilton, Bermuda, December 15, 2020 – 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 provided a business update related to the Company's funding position, its AM-301 program for the protection against airborne pathogens and allergens and the ongoing strategy review process.

    Significant change in funding position

    On December 2, 2020, the Company entered into securities purchase agreements with several institutional investors for the purchase and sale of 2,000,000 common shares at an offering price of $4.00 per share, pursuant to a registered direct offering. The net proceeds of the offering, which closed on December 4, 2020, were approximately $7.3 million. In addition, certain investors in the May 2019 financing of common shares and warrants exercised warrants for 1,263,845 common shares at the exercise price of CHF 4.34 (approximately $4.82) per share, for net proceeds of CHF 5.5 million. Taken together, these two transactions provided net proceeds of approximately $13.4 million to the Company.

    Further progress with AM-301 program     

    The Company's AM-301 program for the development of a drug-free nasal spray for protection against airborne pathogens and allergens, is progressing towards important milestones. The Company's affiliate Altamira Medica Ltd. is planning to conduct a clinical investigation of AM-301 with human volunteers in an allergen challenge chamber in Europe. Subject to approval by the relevant Ethics Committee, the study is expected to start in the first quarter 2021 and to conclude within approximately 3 months. The Company expects to meet the requirements for CE marking, a prerequisite for commercializing AM-301 in Europe, in the second quarter of 2021. Further, Altamira Medica has requested guidance from the FDA on the proposed product development plan, the applicable regulatory pathway, as well as the potential eligibility for Emergency Use Authorization of AM-301 for use against SARS-CoV-2.

    Strategy review ongoing 

    On September 17, 2020, the Company announced that its Board of Directors had initiated a review of strategic options with the objective of unlocking the potential of its assets and maximize shareholder value. Following the review of various scenarios and opportunities, the Board has entered into discussions with a number of parties about certain potential transactions. At this point, there can be no assurance the Company's strategy review will result in the completion of any particular course of action, and there is no defined timeline for completion of the review process.

    "We are very pleased about the recent capital raises which have significantly strengthened our cash and equity position", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "We estimate that our cash runway now extends to the end of 2021 or into early 2022, thus covering a period during which we expect to reach important milestones. These include the read-out from the Phase 2 clinical trial with AM-125 in acute vertigo and readiness for commercialization of our AM-301 nasal spray for the protection against airborne pathogens and allergens."    

    About AM-301

    AM-301 is a drug-free nasal spray for personal protection against airborne pathogens 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 other pathogens and allergens with cells; in addition, the composition serves to "trap" 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. In an in vitro model of reconstituted human nasal epithelia infected with SARS-CoV-2, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection. 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls (p<0.01). 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively (p<0.001).  

    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 pathogens 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.

    Investor contact:

     



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  1. Hamilton, Bermuda, December 2, 2020 – Auris Medical Holding Ltd. (NASDAQ:EARS) ("Auris" or the "Company"), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced it has entered into securities purchase agreements with institutional investors for the purchase and sale of 2,000,000 common shares, par value CHF 0.01 per share, at an offering price of $4.00 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be approximately $8,000,000 before deducting fees and other estimated offering expenses. The Company intends to use the net proceeds for working…

    Hamilton, Bermuda, December 2, 2020 – Auris Medical Holding Ltd. (NASDAQ:EARS) ("Auris" or the "Company"), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced it has entered into securities purchase agreements with institutional investors for the purchase and sale of 2,000,000 common shares, par value CHF 0.01 per share, at an offering price of $4.00 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be approximately $8,000,000 before deducting fees and other estimated offering expenses. The Company intends to use the net proceeds for working capital and general corporate purposes. The closing of the registered direct offering is expected to take place on or about December 4, 2020, subject to the satisfaction of customary closing conditions. 

    A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

    This offering was made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-228121) previously filed with the U.S. Securities and Exchange Commission (the "SEC").  This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  A prospectus supplement relating to the common shares will be filed by Auris with the SEC.  When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by email at  

    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 pathogens 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 release may contain forward-looking statements that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as "may", "will", "aim", "will likely result", "believe", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", "seek to", "future", "objective", "goal", "project", "should", "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the Company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company's most recent Forms 20-F and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

    Investor contact:

     



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    • Results suggest potential for AM-301 nasal spray to mitigate risk of Sars-CoV-2 infection

    Hamilton, Bermuda, December 1, 2020 – 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 positive efficacy data from testing AM-301 in vitro. AM-301 is a drug-free nasal spray being developed by the Company's affiliate Altamira Medica for protection against airborne pathogens and allergens.

    AM-301 was tested for its capability to prevent or mitigate SARS-CoV-2 infection of nasal epithelial cells, which are part…

    • Up to 99.4% reduction of viral titer in human epithelial cell culture (p<0.001)
    • Results suggest potential for AM-301 nasal spray to mitigate risk of Sars-CoV-2 infection

    Hamilton, Bermuda, December 1, 2020 – 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 positive efficacy data from testing AM-301 in vitro. AM-301 is a drug-free nasal spray being developed by the Company's affiliate Altamira Medica for protection against airborne pathogens and allergens.

    AM-301 was tested for its capability to prevent or mitigate SARS-CoV-2 infection of nasal epithelial cells, which are part of the nasal mucosa and the first barrier against continuously inhaled substances such as pathogens and allergens. The experiment was performed over four days on reconstituted human nasal epithelia, which are frequently used to study the effects of human respiratory viruses. In saline-treated control cultures, Sars-CoV-2 replicated efficiently, resulting in a rapid increase in viral titer (as measured by the Median Tissue Culture Infectious Dose, TCID50). In contrast, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection. 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls (p<0.05). 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively (p<0.001). Even when unbound virus was not removed daily through apical washing, allowing the virus to accumulate in the culture for 4 days, the reduction in viral titer was 92.4% compared to saline-treated controls (p<0.001).    

    "We are very excited to see the protective effects of AM-301 against Sars-CoV-2 confirmed in an assay that very closely replicates real-life conditions in the human nose", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Our first experiments in September showed that AM-301's key component trapped up to 99% of Sars-CoV-2 when brought into contact with a viral suspension. Now, with our newly developed spray formulation, we have direct evidence that AM-301 has the potential to significantly mitigate the risk of infection of nasal mucosal cells. We look forward to taking AM-301 through additional tests and advancing the program towards the submission of regulatory applications in 2021."    

    About AM-301

    AM-301 is a drug-free nasal spray for personal protection against airborne pathogens 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 other pathogens and allergens with cells; in addition, the composition serves to "trap" 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 pathogens 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.

    Investor contact:

      

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  2. Hamilton, Bermuda, November 20, 2020 – 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 the launch of a dedicated website for its affiliate Altamira Medica Ltd. The website, www.altamiramedica.com, offers quick and easy access to information about the Company's development of AM-301, a drug-free nasal spray intended for self-protection against risks from exposure to airborne viruses and allergens.   

    Altamira Medica Ltd. was set up in September 2020 as a subsidiary of Auris Medical Holding Ltd. to focus on and expedite the development of AM-301. Upon application into the…

    Hamilton, Bermuda, November 20, 2020 – 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 the launch of a dedicated website for its affiliate Altamira Medica Ltd. The website, www.altamiramedica.com, offers quick and easy access to information about the Company's development of AM-301, a drug-free nasal spray intended for self-protection against risks from exposure to airborne viruses and allergens.   

    Altamira Medica Ltd. was set up in September 2020 as a subsidiary of Auris Medical Holding Ltd. to focus on and expedite the development of AM-301. 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 airborne viruses and allergens with cells; in addition, the composition serves to "trap" 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. The potential protective effects of AM-301 have been demonstrated to date in a SARS-CoV-2 assay. A short contact between AM-301's key component and the virus suspension was sufficient to reduce the viral infectious load by up to 99%.

    "We are proud to provide further updates on our AM-301 program through the new dedicated website", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Since the announcement of the program, we have received a lot of positive feedback on our approach of providing a simple, effective and affordable means for reducing risk when potentially exposed to airborne viruses or allergens. We are working hard to advance the AM-301 project quickly and aim to submit regulatory applications in 2021." 

    Altamira Medica's website will be continuously updated with development updates, relevant background information and press releases.  

    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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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.

    Investor contact:

    Joseph Green

    Edison Advisor for Auris Medical

    646-653-7030

    or

     



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  3. Hamilton, Bermuda, October 13, 2020 – Auris Medical Holding Ltd. (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that the first patient has been randomized in Part B of its "TRAVERS" Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020, the completion of enrollment into the oral treatment group, and the receipt of regulatory clearance for Part B in the first three of the participating study countries.

    In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from…

    Hamilton, Bermuda, October 13, 2020 – Auris Medical Holding Ltd. (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that the first patient has been randomized in Part B of its "TRAVERS" Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020, the completion of enrollment into the oral treatment group, and the receipt of regulatory clearance for Part B in the first three of the participating study countries.

    In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute vertigo following neurosurgery. They will be randomized to receive either 10 or 20 mg of intranasal betahistine or a placebo three times daily for four weeks. The improvement in the "Standing on Foam" test from baseline to Day 14 will be the primary efficacy endpoint; the improvement in the "Tandem Romberg" test to Day 42 (i.e. two weeks after completion of treatment) will be the key secondary efficacy endpoint. The two tests measure how long patients are able to maintain balance on a foam mat or with the two feet aligned one after the other, respectively, while they have their eyes closed. As the Company remained blinded to treatment allocation during the interim analysis, the corresponding data from Part A will be pooled with those from Part B.

    "In Part A of the TRAVERS trial, we demonstrated good safety and tolerability of AM-125 and observed a compelling dose response effect with active treated patients, showing up to 1.9 to 2.4 times better performance in key balance tests," commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "With Part B, we aim to confirm these positive outcomes with the two highest doses in a larger patient sample and, based on those results, advance the program into Phase 3 development. For patients suffering from vertigo, regaining balance as quickly as possible is of utmost importance. Unlike other vertigo drugs that suppress the vestibular function to treat just short-term symptoms such as nausea, AM-125 acts as a vestibular stimulant to enhance and accelerate vestibular compensation and help patients to ‘get back on their feet'."

    The Company expects to complete enrollment into Part B of the TRAVERS trial by the end of the first quarter 2021, provided that the Covid-19 pandemic does not cause further restrictions on patient enrollment.   

    About Betahistine

    Betahistine is a small molecule structural analog of histamine, which acts as an agonist at the H1 and as an antagonist at the H3 histamine receptors. Unlike histamine, it crosses the blood-brain-barrier. It is known to enhance inner ear and cerebral blood flow, increase histamine turnover and enhance histamine release in the brain, increase release of acetylcholine, dopamine and norepinephrine in the brain and to result in general brain arousal. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.

    About AM-125

    Intranasal betahistine is being developed under project code AM-125 for the treatment of acute vertigo. Betahistine has been shown to increase cochlear, vestibular and cerebral blood flow, facilitate vestibular compensation and inhibit neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere's disease.

    About Auris Medical

    Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology 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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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.

    Investor contact:

    Joseph Green

    Edison Advisor for Auris Medical

    646-653-7030

    or

     

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