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Auris Medical Holding Ltd. (NASDAQ: EARS) has launched a dedicated website for its subsidiary, Altamira Medica Ltd., aimed at promoting its AM-301 nasal spray, designed to protect against airborne viruses and allergens. The website offers insights into AM-301's development and its efficacy, having demonstrated up to a 99% reduction in viral load in SARS-CoV-2 assays. The company plans to submit regulatory applications for AM-301 in 2021, indicating a commitment to advancing its product pipeline.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced the randomization of the first patient in Part B of the "TRAVERS" Phase 2 trial for AM-125, an intranasal betahistine treatment for acute vertigo. Following a positive interim analysis for Part A, the trial aims to enroll 72 patients post-neurosurgery. The primary endpoint is the improvement in balance tests by Day 14. The company expects to complete enrollment by Q1 2021, subject to COVID-19 restrictions. Betahistine, known for its good safety profile, is currently available for oral use in many countries, excluding the US.
Auris Medical Holding Ltd. (NASDAQ: EARS) provided a business update and financial results for H1 2020, reporting a net loss of CHF 2.7 million or CHF 0.58 per share. Key milestones include positive interim results from the Phase 2 trial of AM-125 for acute vertigo, demonstrating significant improvement over placebo in balance tests. The company also reported positive results from the AM-201 trial aimed at preventing weight gain from antipsychotics. Additionally, Auris Medical initiated the development of AM-301, a nasal spray to protect against airborne pathogens, with in vitro tests indicating a 99% reduction in SARS-CoV-2 viral load.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced a business update and first-half 2020 financial results release scheduled for September 17, 2020. Following this, management will host a conference call at 8:30 AM ET. The company is focused on developing therapeutics for neurotology and CNS disorders, with products like intranasal betahistine (AM-125, Phase 2) and nasal spray for airborne protection (AM-301). Auris Medical also has two Phase 3 programs: Sonsuvi® (AM-111) for hearing loss and Keyzilen® (AM-101) for tinnitus.
Auris Medical (NASDAQ: EARS) announced positive interim results from its Phase 2 TRAVERS trial of intranasal betahistine (AM-125) for vertigo treatment. The trial showed a dose-dependent improvement in balance tests, with the 20 mg dose demonstrating a 1.9 to 2.4 times greater improvement compared to placebo. The company plans to advance to Part B, testing 10 and 20 mg doses against placebo in a larger cohort. With a significant portion of the US population suffering from vestibular dysfunction, AM-125 aims to address this unmet medical need.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced it has regained compliance with Nasdaq listing requirements as of August 20, 2020. The company received confirmation that its shares maintained a closing bid price of at least $1.00 for ten consecutive business days, resolving prior compliance issues. Auris Medical focuses on developing therapeutics for neurotology and CNS disorders, with ongoing Phase 3 programs for acute inner ear conditions. The company emphasizes its commitment to addressing unmet medical needs in these areas.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced the completion of patient enrollment in Part A of its Phase 2 TRAVERS trial, testing intranasal betahistine (AM-125) for vertigo. The trial enrolled 30 patients and aims to assess vestibular function improvement. Interim results will be released in Q3 2020, prior to starting Part B of the trial with an estimated 72 patients. The company's founder highlighted a quick recovery in study activities following COVID-19, enhancing recruitment rates for future phases.
Auris Medical Holding Ltd. (NASDAQ: EARS) reported positive results from its Phase 1b trial of AM-201, demonstrating significant reduction in weight gain induced by olanzapine. The trial showed a mean weight gain of 2.8 kg for subjects receiving AM-201, compared to 3.7 kg in controls, achieving a statistically significant reduction (p<0.02). Additionally, the company announced that enrollment in the Phase 2 TRAVERS trial of AM-125 for acute vertigo has resumed after delays due to COVID-19. The treatment was well tolerated with no adverse effects noted.