CEBINA Announces Positive Results of a Phase 2 Clinical Study
with COVID-19 patients and Azelastine Nasal Spray Published
in a Peer-Reviewed Scientific Journal
Vienna, 2nd May 2023
CEBINA GmbH, Central European Biotech Incubator and Accelerator, today announces the publication of the positive results of a Phase 2 clinical study that tested azelastine nasal spray as a new approach for reducing viral load in the nose of SARS-CoV-2 positive patients in the peer-reviewed journal Scientific Reports .
Vaccines have been a useful tool to control the COVID-19 pandemic, but have limitations that other complementary approaches such as topical antivirals can address. Azelastine, a widely used anti-histamine, was previously identified as an antiviral drug by CEBINA based on in vitro activity against SARS-CoV-2 and other viruses, such as respiratory syncytial (RSV) and influenza viruses.
The recently published peer-reviewed article describes the final results of the Phase 2 clinical study CARVIN conducted in Germany that tested azelastine nasal spray in SARS-CoV-2 infected individuals. The study, jointly funded by CEBINA and URSAPHARM Arzneimittel, was a proof of concept efficacy trial, randomized, double-blinded, and placebo-controlled, involving 90 SARS-CoV-2 positive volunteers who received either placebo or azelastine nasal spray for a period of 11 days. Treatment with azelastine nasal sprays resulted in a greater decrease in mean viral load compared to that measured in the placebo group at all the timepoints after initiation of treatment, without adverse health events.
“The publication of these data on azelastine efficacy against the SARS-CoV-2 virus demonstrates that azelastine nasal spray is a promising solution to combat viral infections in the early phase when the virus is mainly located in the nose. The data further supports our goal to develop azelastine as a broad anti-viral approach, especially now when we are experiencing increased incidence of upper respiratory viral infections as the consequence of reduced exposure during lock-down and mask protection”. commented Eszter Nagy, MD PhD, CEO, CSO and founder of CEBINA, co-author of the published paper.
CEBINA holds granted patents in the EU and US on the use of azelastine as anti-SARS-CoV-2 solution. URSAPHARM Arzneimittel has initiated an additional Phase 2 study in India and a multi-national Phase 3 clinical study in Europe testing the efficacy of their marketed azelastine containing nasal spray, Pollival® in COVID-19 patients. Another ongoing trial is testing the prophylactic potential of Pollival® for SARS-CoV-2 as well as for other viruses such as seasonal coronavirus, influenza and RSV infections.
CEBINA GmbH – Central European Biotech Incubator and Accelerator (www.cebina.eu) is an Austria-based company committed to advancing entrepreneurship through creating and nurturing early-stage life science projects and companies to develop new medicines and cutting-edge technologies. CEBINA offers office and laboratory facilities, in-house research, development, financing and management capabilities to early and medium stage biotech companies. CEBINA has initiated multiple R&D projects to fight the COVID-19 pandemic; the drug repurposing project that identified azelastine as an antiviral is currently in Phase 2 and 3 clinical testing.
Sophie Zettl, PhD
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