August 11, 2020
BioAegis Therapeutics has chosen EastHORN as its partner to expedite the development of its potential COVID-19 treatment. The two companies have worked together on the clinical development of BioAegis’s lead candidate since 2018. The first COVID-19 patients were given the product in early August 2020.
“We are privileged to be in a position to provide clinical and regulatory expertise to BioAegis in a range of countries across Europe”, said Iain Gordon, Chief Business Officer at EastHORN. “We have been working tirelessly to develop a strategy whereby we can optimise access to patient populations as the infection rate ebbs and flows across all parts of Europe”.
BioAegis Therapeutics believes that its lead product, recombinant human plasma gelsolin therapy (rhu-pGSN), is a viable therapeutic option for patients suffering from severe lung injury due to COVID-19. Dr. Susan Levinson, BioAegis CEO commented, “We’ve been studying this exact same condition, not with this particular virus, but with severe flu, for years, so we feel like we are in the perfect position to treat this disease”.
As of early August, there are more than three thousand COVID-19 clinical trials taking place worldwide. Of those researching therapeutic treatments for the acute conditions associated with COVID-19, by far the majority are investigating the repurposing of existing approved and marketed drugs. Gordon explained: “It’s a lot easier to get a study up and running when you are using an existing product that has already been approved by the relevant regulatory agencies. In this case we are working with a Phase II investigational medicinal product (IMP), but despite this we have already managed to assemble the full regulatory dossier, recruit hospitals, receive regulatory approval and give the product to the first patients. The relevant competent authorities promised to prioritise review of the application and expedite their response. We would like to recognise the responsiveness and encouragement of the regulatory agencies in both Western and Eastern Europe”.
The study will assess the efficacy (survival without organ failure on Day 14 without mechanical ventilation, vasopressors or dialysis) of three doses of rhu-pGSN administered intravenously to hospitalised subjects with a primary diagnosis of COVID-19 pneumonia and a severity score of 4, 5 or 6 on the World Health Organization (WHO) 9-point severity scale. It will also measure the safety and tolerability of treatment along with secondary outcomes.
Dr Levinson added, “We are excited to move forward with this study to address the most severe outcomes of COVID-19. Two recent independent publications confirm that COVID 19 patients with lower gelsolin levels are more likely to exhibit organ damage and have higher WHO scores”.
EastHORN Clinical Services is a contract research organisation (CRO) operating in more than 25 countries, providing support and solutions to a range of pharmaceutical and biotech companies across the globe.
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© EastHORN Clinical Services | August 2020