EARS - Auris Medical updates on AM-301 program in allergic rhinitis
Auris Medical (EARS) and its affiliate Altamira Medica provide an update on its AM-301 program for protection against airborne viruses and allergens.Clinical evaluation of AM-301 nasal spray in allergic rhinitis meets primary endpoint, AM-301 effectively alleviates allergy symptoms in clinical pollen challenge. Furthermore, rapid onset and long durability of AM-301’s protective effect was seen, maintained for at least three hours. AM-301 helps to reduce growth in infectious titer in ongoing SARS-CoV-2 infection. In control cultures, SARS-CoV-2 replicated efficiently over four days, resulting in a rapid increase in viral titer.Daily treatment with AM-301 resulted in a statistically significant deceleration of the viral titer growth compared to controls (p-value <0.01, linear mixed-effects model).At Day 4 of the experiment, viral titers were 73.7 to 94.5% lower compared to controls. Upon readiness for CE mark conformity, Altamira Medica expects to submit a 510(k) pre-market notification application to the FDA requesting regulatory clearance for AM-301 for the
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Auris Medical updates on AM-301 program in allergic rhinitis