The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia, pending approval from the Ministry of Health of the Russian Federation. An IND has been submitted to the Ministry of Health and clinical sites have been selected for a Phase I/II study. Per the agreement, Pharmsynthez will purchase HFB30132A for clinical trials in Russia. Upon regulatory approval, Pharmsynthez will continue to commercialize the product as the exclusive partner of HiFiBiO Therapeutics in Russia. HiFiBiO Therapeutics retains all rights and continues to develop and commercialize HFB30132A globally.
HiFiBiO has leveraged its expertise in immune modulation and single-cell science to rapidly discover, engineer, and develop HFB30132A in less than six months. Additionally, the company is currently dosing the second cohort of healthy volunteers in a Phase I ascending dose study (NCT04590430) to assess the safety, tolerability and pharmacokinetics of HFB30132A. This Phase I study will be followed by global phase II/III clinical trials in high-risk adults with asymptomatic or mild to moderate COVID-19.
“We are excited to partner with Pharmsynthez and leverage its expertise and resources to successfully develop and deliver this innovative therapy to patients in Russia,” said Jeff He, Chief Operating Officer of HiFiBiO Therapeutics. “This strategic partnership showcases our open innovation approach and the global collaboration required to rapidly address this pandemic.”
“We expect that HFB30132A will be able to provide a reliable level of protection for people infected with the virus, especially for those who have risk factors such as cardiovascular disease or weakened immunity,” said Kirill Mayorov, President of Pharmsynthez. “This antibody has the potential to help fight active infections and prevent a cascade of serious complications that we have seen around the world. Given the severity of the epidemiological situation, Pharmsynthez will do its best to integrate HFB30132A into the arsenal of Russian medicine once we receive regulatory approval.”
Source: Company Press Release