Regulators in the US have approved Rhizen Pharmaceuticals’ Investigational New Drug (IND) application to study its oral DHODH inhibitor for SARS-CoV-2 infection.
The company’s initial study shall evaluate single ascending doses of RP7214 in healthy volunteers and that dosing is expected to commence in early December 2020.
Dihydroorotate dehydrogenase (DHOHD) is a key enzyme involved in pyrimidine biosynthesis in the cell. RP7214 is potentially a best-in-class selective DHODH inhibitor that has shown potent inhibition of COVID-19 viral replication.
RP7214 has also been studied extensively across multiple inflammation models where it has demonstrated excellent anti-inflammatory activity. Further, the IND-enabling preclinical studies have shown RP7214 to be orally available, safe and tolerable with predictable dose-linear pharmacokinetics.
The host-based mechanism of RP7214 could allow complementary combinations with direct acting anti-viral drugs, while the broad anti-inflammatory action could potentially mitigate the cytokine mediated inflammatory symptoms typically seen in SARS-CoV-2 & other viral infections.
“RP7214 has a unique preclinical profile, high oral bioavailability, robust anti-viral potency and broad anti-inflammatory role, that we expect will translate in the clinic and support its eventual development as a potential treatment for COVID-19,” said Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals.