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Trial Underway Testing Cancer Drug as Covid-19 Therapy

SARS-CoV-2 and cell

Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)

22 Sept 2021. A clinical trial enrolled and dosed its first participant testing an oral drug, initially designed to treat cancer, as a therapy for mild Covid-19 infections. Rhizen Pharmaceuticals AG in Basel, Switzerland is conducting the trial of its cancer drug code-named RP7214 among Covid-19 patients in India.

Rhizen Pharma discovers and develops drugs mainly for cancer and inflammatory disorders. The company originally designed RP7214 as an oral small-molecule therapy for acute myeloid leukemia or AML and solid tumor cancers, with the drug in an early-stage clinical trial for AML and preclinical testing for solid tumors. RP7214 blocks effects of dihydroorotate dehydrogenase or DHODH enzymes implicated in the proliferation of cancer cells, but more recent findings suggest DHODH inhibitors can also treat Covid-19 infections.

For Covid-19, says Rhizen Pharma, RP7214 acts on the host cells targeted for infection rather than the SARS-CoV-2 virus itself. The DHODH inhibitors in RP7214 deplete nucleic acids in host cells that would normally support infecting proteins from SARS-CoV-2 viruses, blocking further viral replication. In addition, says the company, the known SARS-CoV-2 variants use the same host-cell mechanisms for replication, suggesting RP7214 should be equally effective against infections from different variants.

Gauging hospitalization rates among trial participants

Rhizen Pharma says an early-stage clinical study with healthy volunteers in the U.S. shows RP7214 is well-tolerated in single or multiple doses, and under feeding or fasting conditions. In addition, results show RP7214 is absorbed well by the body and transfers into the blood stream of recipients.

The new clinical trial is a mid-stage study enrolling 204 participants at 12 sites in India. The trial, conducted with Incozen Therapeutics in Hyderabad, India, is recruiting patients diagnosed with mild cases of Covid-19, exhibit one or more symptoms of the disease, and are in a high-risk category for Covid-19 disease, such as older age. Participants are randomly assigned to receive RP7214 or placebo tablets twice a day for 14 days, and otherwise receive standard care. The study team is looking primarily for hospitalization rates among participants after 15 days, but also changes in viral load in that time, percentage resolving or improving symptoms, changes in inflammatory markers, and signs of adverse effects.

“In this study,” says Rhizen Pharma founder and CEO Swaroop Vakkalanka in a company statement released through BusinessWire, “we expect to get a read on the ability of RP7214 to inhibit the viral replication and clearance, and induce an anti-inflammatory response.”

Rhizen Pharma also believes RP7214 can work with other antiviral drugs against Covid-19 and similar RNA-based viral infections. “Given the orthogonal nature of this host-directed mechanism of RP7214,” adds Vakkalanka, “we expect that RP7214 will eventually also combine well with direct acting antiviral agents, across a broad range of RNA-viral indications.”

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