Rhizen Pharmaceuticals, an associate company of Alembic Pharmaceuticals, on Wednesday said it’s received approval from the US health regulator to commence phase one clinical trials on retroviral oral drug for the treatment of Covid-19.
The Switzerland-based firm, which may be a clinical-stage oncology-focussed biopharmaceutical company, has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to review its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 infection, Rhizen Pharmaceuticals S A said during a statement.
The initial study would evaluate single ascending doses of the RP7214 in healthy volunteers which dosing is predicted to commence in early December, it added.
The company has also received regeneration 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 may be a key enzyme involved in pyrimidine biosynthesis within 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 1 clinical test for the treatment of Covid-19,” Rhizen Pharmaceuticals President and CEO Swaroop Vakkalanka said.
RP7214 features a unique preclinical profile, high oral bioavailability, robust antiviral potency and broad anti-inflammatory role, that the corporate expects will translate within the clinic and support its eventual development as a possible treatment for Covid-19, he added.
Commenting on the event , Alembic Pharmaceuticals director Pranav Amin- said: “Its exciting development that our team Rhizen is functioning on and that we hope on, an oral retroviral, which can add a replacement dimension to treatment of Covid-19”.