reports
- Sean Conroy
- Sean Conroy
Auris Medical Holding - A nasal spray to help protect against COVID-19
Auris recently announced the development of the AM-301 nasal spray for protection against SARS-COV-2 (COVID-19) infection (though it is also intended to protect against other airborne pathogens and allergens as well). AM-301 is a gel that would form a protective layer in the nasal mucosa, preventing contact between the pathogen and cells. In vitro data so far suggest contact between AM-301 and COVID-19 reduced the viral load by up to 99%. The company is targeting regulatory submission as an over...
- Sean Conroy
Auris Medical Holding - AM-201 data expected in early May
Auris has announced that final data from its 80-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence should be available in early May. The key component of this release will be the data from the final dose level of 30mg in 30 healthy volunteers (we had previously only seen data in patients dosed up to 20mg). Due to the coronavirus, enrolment has been paused in the Phase II TRAVERS trial of 118 patients with surgically induced acute vertigo. Interim data from Part A of ...
- Sean Conroy
Auris Medical Holding - Interim AM-201 data
Auris has announced interim data from its 50-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence. The drug demonstrated safety and tolerability and provided initial signals of efficacy (limitations of the trial in terms of size and duration hamper its ability to provide definitive evidence). In the female study subjects, who showed more pronounced changes than the male study subjects, AM-201 demonstrated a 1.1kg benefit versus placebo over four weeks in those who rece...
- Maxim Jacobs
Auris Medical Holding - AM-201 proof of concept data is weeks away
Auris Medical Holding announced in July that the 50-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence completed enrolment, with top-line data in five dose levels expected in the coming weeks. Due to the positive safety profile seen in the trial so far (efficacy is unknown as the company is blinded), the company is seeking to extend the trial by adding two higher dose cohorts, with data from these expected around Q120. The company has also initiated the 138-patient A...
- Maxim Jacobs
Auris Medical Holding - Data coming in second half
Auris recently announced that the TRAVERS Phase II trial of AM-125 (intranasal betahistine) for treating acute vertigo is being initiated at study sites as regulatory and ethics committee approvals are coming in. An interim analysis of the data is expected in Q419. Also, its AM-201 Phase I trial for olanzapine-induced weight gain reached the midpoint in enrollment in early May and is on track for full enrollment by the end of June. Top-line data is expected in Q319.
- Maxim Jacobs
Auris Medical Holding - Full-year results and near-term trial initiati...
Auris recently announced its full-year 2018 financial results and provided an update on its active intranasal betahistine programs. R&D expenditure for the year was down roughly 65% compared to FY17, which reflects the shift to focus on earlier-stage program development. Auris plans to initiate the AM-125 Phase II trial of intranasal betahistine for treating acute vertigo in Q119 following the finalisation of clinical site selection, which it states is nearly complete. Additionally, Auris plans ...
- Maxim Jacobs
Auris Medical Holding - Q318 results and business updates
Auris Medical recently reported its Q318 results and provided a brief business update on its active programs. R&D expenditure for the period was down roughly 60% over Q317, which reflects management’s swift pivot to focus on Phase I development. Auris plans to initiate two intranasal betahistine trials in Q119: the AM-125 Phase II trial in acute vertigo and AM-201 Phase I trial for olanzapine-induced weight gain.
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