STARPHARMA HOLDINGS

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Starpharma Holdings Limited Announces Publication of New Data Demonstrating the Protective Efficacy of VIRALEZETM Antiviral Nasal Spray against SARS-CoV-2 Challenge in Vivo

08/22/2021 | 08:23pm
Starpharma Holdings Limited announced publication of new data demonstrating the protective efficacy of VIRALEZETM antiviral nasal spray against SARS-CoV-2 challenge in vivo in a humanised mouse model of coronavirus infection. The results of the study have been published in the international peer- reviewed journal, Viruses, in a special issue titled, Medical Interventions for Treatment and Prevention of SARS-CoV-2 Infections. The model used in this study of VIRALEZETM is one of the few animal models endorsed by the World Health Organisation (WHO) to accelerate the testing of vaccines and therapeutic agents for COVID-19. The transgenic mouse model expresses the human angiotensin converting enzyme (hACE2) receptor used by SARS-CoV-2 to infect cells in the human nasal cavity and respiratory tract. The study, conducted at The Scripps Research Institute in the US, showed that VIRALEZETM administered nasally significantly reduced viral load by more than 99.9% in the lungs and trachea of animals challenged with SARS-CoV-2, compared with the virus levels in control animals. Animal challenge models of SARS-CoV-2 provide an opportunity to investigate aspects of the pathogenesis of disease that are not easily, nor able to be, studied in humans. The impressive protective effects of VIRALEZETM against SARS-CoV-2 in this animal model are entirely consistent with the previously reported in vitro virucidal activity of SPL7013 4, which has been shown to reduce infectious SARS-CoV-2, including the Delta Variant of Concern, by >99.9% within 30 seconds of exposure. The production of pro-inflammatory cytokines ("cytokine storm"), in response to SARS-CoV-2 challenge, which can cause significant illness and death in humans after SARS-CoV-2 infection was also significantly reduced in VIRALEZETM treated animals with compared to control animals. VIRALEZETM nasal spray also significantly reduced SARS-CoV-2 viral load in the nasal cavity of treated animals, and remarkably, the same animals had no infectious SARS-CoV-2 virus in both brain or liver, in contrast to all control animals, which had significant levels of virus. Collectively, these data illustrate, in this in vivo animal model, the ability of nasally administered VIRALEZETM to inactivate virus and reduce viral load in the nose, trachea, lung and blood, and the resulting protective benefits of this action on the inflammatory cytokine response. VIRALEZETM is a broad-spectrum antiviral nasal spray that has been developed by Starpharma with the intention of being applied in the nasal cavity to help reduce exposure to viable viral load, thereby helping to protect from infection with respiratory viruses, including SARS-CoV-2. The current study conducted at the Scripps Research Institute used the K18-hACE2 mouse model 5 to evaluate the anti-SARS-CoV-2 efficacy of VIRALEZETM antiviral nasal spray. This model is an established challenge model for investigation of coronavirus SARS-CoV-2 infection, where the animals express the human ACE2 receptor that is responsible for mediating virus and cell receptor interactions (i.e., allowing virus to enter the cell, which leads to infection). These new data provide in vivo validation that the nasal administration of VIRALEZETM inactivates virus, resulting in: reduced viral load in the respiratory tract (nose, trachea, lungs); reduced virus replication in the nasal cavity and respiratory tract; reduced pro-inflammatory cytokine production; and a significant reduction in the extent and severity of SARS-CoV-2 replication and pathogenesis caused by SARS-CoV-2 infection via the nasal passages. Data from around the world indicate that vaccines against COVID-19 are highly effective in preventing hospitalisation and death, but that vaccinated individuals can still become infected and shed virus. Complementary interventions that can reduce viral load at the primary site of initial infection will therefore continue to be helpful to reduce transmission of virus from infected individuals, particularly in the current environment where the dominant variants of SARS-CoV- 2 (Alpha, Beta, Gamma and Delta) have higher transmission rates and have demonstrated evidence of vaccine escape.
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