FDA approves Rhizen Pharmaceuticals’ application to study Covid-19 drug

The US Food and Drug Administration (FDA) has approved Rhizen Pharmaceuticals’ Investigational New Drug (IND) application to study its dihydroorotate dehydrogenase (DHOHD) inhibitor, RP7214, for SARS-CoV-2 infection.

The selective, oral DHOHD inhibitor demonstrated potent inhibition of Covid-19 viral replication.

DHOHD is a key enzyme in pyrimidine biosynthesis in cells.

The initial study to analyse single ascending doses of RP7214 in healthy participants should begin this month.

Rhizen Pharmaceuticals president and CEO Swaroop Vakkalanka said: “There is an exceptional need for oral antiviral drugs that are suitable for Covid-19 treatment across all hospital and out-patient settings.

“We are pleased to advance RP7214 into a Phase I clinical trial for the treatment of Covid-19 under a US FDA IND.

“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.”

Rhizen Pharmaceuticals plans to conduct a multiple-ascending dose study in Covid-19 patients in line with positive feedback from the FDA during pre-IND discussions, followed by the initial study.

In the preclinical studies, RP7214 was reportedly orally available, safe and tolerable with predictable dose-linear pharmacokinetics.

Further, RP7214 underwent analysis across different inflammation models and showed exceptional anti-inflammatory activity.

With its host-based mechanism, the drug can potentially be combined with direct-acting antiviral agents.

The broad anti-inflammatory action of the DHOHD inhibitor could alleviate the cytokine-mediated inflammatory symptoms observed in SARS-CoV-2 and other viral infections.