Hamilton, Bermuda, Aug. 15, 2019 -- Enrollment of first patient in TRAVERS Phase 2 trial with AM-125 in acute vertigoEnrollment completed in Phase 1b trial with AM-201 in.
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Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced positive interim results from its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and somnolence. The study demonstrated good safety and tolerability of AM-201 over the four-week treatment period and revealed relevant reductions in olanzapine-induced weight gain and daytime sleepiness. In female study participants, who overall showed more pronounced changes than male participants, a reduction in weight gain of 1.1 kg against placebo was observed at the highest tested dose of 20 mg three times per day (probability of effectiveness = 90%).
Auris Medical Holding Ltd. (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 European Patent Office (EPO) has issued a notice of “Intention to Grant” for its patent application entitled “Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System” (European Patent Application 11 894 529.3). The communication from the EPO concludes substantive examination of the patent application, which is now expected to issue as a patent once the issue fees are paid and the patent office concludes its respective administrative procedures. A corresponding patent application is currently pending before the US Patent and Trademark Office (USPTO) and was already granted in Japan.
Phase 1b trial with intranasal betahistine for prevention of antipsychotic-induced weight gain progressing towards final read-outPhase 2 trial with intranasal betahistine for.
Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced the formation of a new subsidiary, Zilentin Ltd., to bundle its development projects for the treatment of tinnitus and hearing loss in a separate entity. Upon completion of the transfers from other Group companies, Zilentin AG shall own all tangible and intangible assets related to the development of tinnitus therapeutics (Keyzilen® / AM-101 as well as early stage projects) and hearing loss therapeutics (Sonsuvi® / AM-111). Zilentin Ltd. is domiciled in Zug, Switzerland.
Auris Medical Holding Ltd. (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 it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen® (AM-101) from the U.S. Food and Drug Administration (“FDA”) and from the European Medicines Agency (“EMA”). The Company had reached out to the two agencies in order to discuss and validate the design of a new Phase 2/3 trial for the Keyzilen® program. In their feedback, both the FDA and EMA supported the use of the Tinnitus Functional Index (TFI) questionnaire as the primary efficacy outcome measure.
Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today highlighted the publication of an article describing the anti-epileptic and anti-convulsive activity of betahistine in a mouse model. The article was written by an independent Iranian research group and presents the outcomes of a study on the effects of betahistine on seizure scores, memory deficits, depression, and neuronal loss in a murine model of epilepsy. The researchers found that pretreatment and repetitive treatment with intraperitoneal betahistine entirely prevented generalized tonic-clonic seizures induction and significantly diminished seizure intensity.
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Auris Medical Holding Ltd. (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 United States Patent and Trademark Office (USPTO) has issued a notice of allowance for its patent application entitled “Pharmaceutical Composition Comprising Betahistine” (U.S. Patent Application No. 15/887,388). In addition, the Company received an “Intention to Grant” notice from the European Patent Office (EPO) for its related patent application entitled “Intranasal Composition Comprising Betahistine” (European Patent Application 18 703 749.4).
We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. On...
Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced the appointment of Elmar Schärli, CPA, as new Chief Financial Officer, effective November 1, 2019. “We’d like to thank Hernan for his years of service and many contributions to Auris, and we wish him all the best in his new position.” Hernan Levett will be staying with Auris Medical through October 31 to ensure a smooth transition. Elmar Schärli has acquired almost 30 years of both private and public company finance and accounting experience in the biotech and medtech industry.
Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced positive top-line data from its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and provided an update on the enrollment into its Phase 2 trial with AM-125 in vertigo. The Phase 1b trial demonstrated good safety and tolerability of ascending doses of AM-201 as well as a dose-dependent reduction in weight gain in healthy volunteers treated with oral olanzapine (10 mg) for four weeks. At the highest AM-201 dose of 30 mg administered three times daily, the mean weight gain from baseline to the end of the treatment period was 2.8 kg compared against 3.7 kg in control subjects; the primary efficacy endpoint of mean reduction in weight gain was 0.9 kg and statistically significant (p<0.02; n=81 with pre-specified Bayesian augmented controls).
NEW YORK, NY / ACCESSWIRE / March 26, 2020 / Auris Medical Holding Ltd. (NASDAQ:EARS) will be discussing their earnings results in their 2019 Second Half Earnings call to be held on March 26, 2020 at 8:00 ...
The TRAVERS trial will enroll a total of 138 patients who suffer from acute vertigo following surgical removal of a vestibular schwannoma, a tumor growing behind the inner ear. In addition, oral betahistine 48 mg will be tested in 16 patients under open-label conditions for reference. “After securing approvals from the numerous regulatory authorities and ethics committees involved, we are excited to start patient enrollment into the TRAVERS trial,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO.
Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today provided an update on the impact of the COVID-19 pandemic on its ongoing clinical trials with intranasal betahistine. The Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, has remained unaffected by the COVID-19 pandemic. The Phase 2 trial with AM-125, intranasal betahistine for the treatment of acute peripheral vertigo, will be impacted by the COVID-19 outbreak.
Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced the formation of a Scientific Advisory Board (SAB) for its tinnitus research and development programs. “We are delighted to have several world-renowned tinnitus experts join Auris Medical as advisors as we are preparing to advance our various tinnitus projects through further clinical and pre-clinical development,” stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “There continues to be a strong unmet medical need amongst tinnitus sufferers worldwide, and we look forward to bringing novel therapeutics to patients.
Auris Medical Holding Ltd. (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today provided an update on its ongoing clinical trials with intranasal betahistine. In the Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, the last subject just had its last treatment visit. In total, the trial enrolled 80 healthy volunteers who received either AM-201 or placebo concomitantly with the antipsychotic drug olanzapine over four weeks.