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Drug major Alembic Pharmaceuticals Ltd on Wednesday said the US drug regulator US Food and Drug Administration (USFDA) has granted approval to it's associate company Rhizen Pharmaceuticals SA for an Investigational New Drug (IND) application to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 infection.
The company announced that initial study shall evaluate single ascending doses of RP7214 in healthy volunteers and that dosing is expected to commence soon.
The company has received positive feedback from the FDA during its pre-IND discussion on its plans to follow-up this study with a multiple-ascending dose study in Covid-19 patients, a statement said.
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, the statement said.
Covid-19 treatment
Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals, 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 1 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, “ he added.
Further, the IND-enabling preclinical studies have shown RP7214 to be orally available, safe and tolerable with predictable dose-linear pharmacokinetics.
New dimension
Pranav Amin, Managing Director of Alembic Pharmaceuticals Ltd, said, “Its exciting development that our team Rhizen is working on and we are hoping on, an oral retroviral, which will add a new dimension to treatment of Covid 19.”
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.
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