The clinical usefulness of an azelastine-containing nasal spray against SARS-CoV-2 has been previously demonstrated in a Phase 2 efficacy indicator study initiated by URSAPHARM Arzneimittel GmbH and CEBINA where a meaningful reduction in nasal viral load in COVID positive subjects was seen. Based on the broader anti-viral effect of azelastine, it is anticipated azelastine may also be effective against the recently discovered Omicron variant of concern, and experiments are underway to confirm this.
The continuous spread of the SARS-CoV-2 virus worldwide has led to a series of emerging new variants of concern, some of which have been reported to be more contagious and to have the potential to cause more severe disease than the original virus. The recently designated variant of concern B.1.1.529, Omicron, has many more mutations in the viral Spike protein than previous variants, and according to preliminary data seems to be highly transmissible and more capable of evading the immune response induced by current vaccines and prior infections. Another concerning trend is the higher incidence of certain respiratory infections that are observed after lockdown periods, especially in the winter seasons as already seen for RSV and expected for influenza. Moreover, respiratory infections can act synergistically leading to increased disease severity. Therefore, broader spectrum anti-viral agents that can prevent or interfere with the most common respiratory viruses in an early stage of infection - namely in the nose – can play an important role during the COVID-19 pandemic.
CEBINA has previously identified the antihistamine drug azelastine as a potential anti-COVID-19 approach, demonstrating that azelastine has potent inhibitory activity against SARS-CoV-2 in in vitro infection models. This has been recently confirmed in a prospective, randomized, double-blind, placebo-controlled Phase 2 clinical trial initiated by CEBINA with its partner URSAPHARM (https://www.researchsquare.com/article/rs-864566/v1), demonstrating that a formulation identical to Pollival® (1mg/ml azelastine), URSAPHARM’s widely available nasal spray containing the antihistamine drug azelastine hydrochloride, was effective in reducing the viral load in the nasal cavity of SARS-CoV-2 positive patients and rendered subjects COVID-PCR test negative earlier, compared to placebo.