Starpharma updates on development of COVID-19 treatment

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Starpharma (ASX:SPL) has updated on progress in the development, regulatory and manufacturing activities associated with a nasal spray for protection against COVID-19 based on the company’s proprietary antiviral dendrimer, SPL7013.

The said it has undertaken development activities for the SPL7013 nasal spray. It has been reformulated into several nasal spray formulations. The company said it has identified a manufacturer and device components, undertaken pilot manufacture, and compiled regulatory documentation in preparation for a submission.

Based on discussions with regulators, the company said it expects to be able to expedite approval of a SPL7013 nasal spray by leveraging existing nonclinical and clinical data of its currently approved and marketed products.

The company announced in April that data has shown the potent antiviral activity of SPL7013 against SARS-CoV-2 -the virus that causes COVID-19 infection.

"Extensive antiviral data has been generated and submitted to a peer reviewed scientific journal and is now available on the preprint server, bioRχiv," said the company.

It said the data confirms that SPL7013 inhibits infection of host cells by SARS-CoV-2 when it is applied to the cells either before or after exposure to the virus.

It said, "The selectivity of SPL7013 for SARS-CoV-2 in these assays was very high (selectivity index3 up to ~2200), indicating potent antiviral efficacy compared with minimal cellular toxicity. The selectivity index is a measure of therapeutic window. The high selectivity index of SPL7013 compares very favourably with the selectivity index against SARS-CoV-2 reported in the literature of 279 for remdesivir and 172 for chloroquine."

"The high potency and high selectivity index of SPL7013 indicate that a final formulated product can and will have a concentration of SPL7013 that is several thousand-fold higher than the concentration shown to exert an antiviral effect on SARS-CoV-2," said the company.

Dr Jackie Fairley, Starpharma CEO, said, “We are pleased to provide an update on the progress with development of the SPL7013 nasal spray. The potent activity of SPL7013 in SARS-CoV-2, its action early in the replication cycle and its selectivity are all positive product features. Whilst effective vaccines will be central to the fight against COVID-19, other preventative measures will continue to be important to reduce the risk of transmission and exposure to SARS-CoV-2. Our strategy for the product includes leveraging Starpharma’s vast body of existing technical data and existing regulatory approvals for SPL7013, to fast-track the regulatory and commercialisation pathways to have the product ready for market as soon as possible.”