Rhizen Pharmaceuticals has dosed the first subject in a Phase II clinical trial of its oral drug, RP7214, in Covid-19 patients with mild and symptomatic disease with an underlying risk factor, in India.
It is the first study of RP7214, a small molecule oral dihydroorotate dehydrogenase (DHODH) inhibitor with reduced nanomolar potency, in Covid-19 patients with mild, symptomatic disease.
RP7214 is estimated to work by hindering the DHODH enzyme on host cells and reduce their ability to aid viral replication.
Rhizen noted that if this particular mechanism of action is found to be successful in clinical trials, RP7214 would be complementary to other antiviral therapies that directly hinder the virus.
The randomised, double-blind, placebo-controlled Phase II trial will assess the efficacy and safety of the drug in Covid-19 patients.
Based on favourable preclinical efficacy and Phase I safety in healthy subjects, a Phase II trial was initiated.
The Phase II trial is being carried out across 12 centres in the country with Rhizen’s India affiliate Incozen Therapeutics, enrolling up to a total of 204 subjects in both trial cohorts.
It will also assess RP7214’s tolerability, immunomodulatory activity and its impact on viral load and clearance, disease biomarkers and clinical improvement in the status of the subjects.
Rhizen Pharma founder and CEO Swaroop Vakkalanka said: “In this study, we expect to get a read on the ability of RP7214 to inhibit the viral replication and clearance and induce an anti-inflammatory response.
“If therapeutically active, we expect RP7214 will play a major role in mitigating and reducing the severity of de novo and breakthrough infections in both unvaccinated and vaccinated individuals, thereby becoming an important public health tool that can help reduce the burden on healthcare systems and allow economic activity to resume.”
RP7214 was previously analysed in a Phase I first-in-human trial in healthy subjects in the US under an investigational new drug (IND) across single-dose, multiple-dose and fed-fasted conditions.
Data showed that the drug was very well-tolerated across all doses analysed, with increased bioavailability and dose-proportional plasma concentrations.
Furthermore, in a preclinical setting, RP7214 showed specific activity on SARS-COV-2 replication without impacting the host cells.
In the future, Rhizen intends to test RP7214 in partially or fully vaccinated individuals with breakthrough Covid-19 infections as part of a wider clinical development programme.