Alembic Pharma rises after USFDA accepts Rhizen's IND application

Alembic Pharmaceuticals rose 1.16% to Rs 996.75 after its associate company, Rhizen Pharmaceuticals, received US drug regulator's approval to study its oral DHODH inhibitor for SARS-CoV-2 infection.

Alembic Pharmaceuticals through its wholly owned subsidiary holds 50% ownership in Rhizen.

Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, on Tuesday (1 December) announced the approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (USFDA) to study its oral DHODH 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 in early December 2020. The company also announces positive feedback from the USFDA during its pre-IND discussion on its plans to follow-up this study with a multiple-ascending dose study in Covid-19 patients.

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.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

Alembic Pharma reported a 35.4% jump in consolidated net profit to Rs 333.37 crore on 17.4% rise in net sales to Rs 1,457.10 crore in Q2 September 2020 over Q2 September 2019.

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