Rhizen Pharma gets USFDA approval for phase one clinical trials of COVID-19 drug

The initial study would evaluate single ascending doses of the RP7214 in healthy volunteers and that dosing is expected to commence in early December.
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Rhizen Pharmaceuticals, an associate company of Alembic Pharmaceuticals, on Wednesday said it has received approval from the US health regulator to commence Phase I clinical trials on retroviral oral drug for the treatment of COVID-19.

The Switzerland-based firm, which is a clinical-stage oncology-focused biopharmaceutical company, has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 virus, Rhizen Pharmaceuticals S A said in a statement.

The initial study would evaluate single ascending doses of the RP7214 in healthy volunteers and that dosing is expected to commence in early December, it added.

The company has also 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, it added.

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.

"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," Rhizen Pharmaceuticals President and CEO Swaroop Vakkalanka said.

RP7214 has a unique preclinical profile, high oral bioavailability, robust antiviral potency and broad anti-inflammatory role, that the company expects will translate in the clinic and support its eventual development as a potential treatment for COVID-19, he added.

Commenting on the development, Alembic Pharmaceuticals Managing Director Pranav Amin- said: "It's an exciting development that our team at Rhizen has been working on and we are hoping on an oral retroviral, which will add a new dimension to treatment of COVID 19".

(Disclaimer: Additional background information has been added to this PTI copy for context)

Edited by Kanishk Singh

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