Alembic subsidiary gets USFDA nod to study oral DHODH inhibitor for SARS-CoV-2 infection

Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, and wholly-owned subsidiary of Alembic Pharma announced on Wednesday, the approval of its Investigational New Drug (IND) application by the US drug regulator, the United States Food and Drug Administration (USFDA) to study its oral DHODH inhibitor for SARS-CoV-2 infection.

Rhizen Pharma announced that its initial study will evaluate ascending doses of RP7214, a DHODH inhibitor which has demonstrated potent inhibition of Covid-19 viral replication. The study is expected to begin as early as December 2020, the company stated in a press release to the BSE.

It further announced 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.

Speaking on the announcement, Mr Swaroop Vakkalanka, President & CEO at Rhizen Pharmaceuticals went on to state that given RP7214’s unique preclinical profile, high oral bioavailability, robust anti-viral potency and broad anti-inflammatory role, it is likely to support the eventual development as a potential treatment for Covid-19.

On Wednesday, the stock of Alembic Pharmaceuticals closed at Rs 991 per share, up by 0.58 per cent or Rs 5.70 per share on BSE, against a 0.08 per cent decline in the benchmark index.