FDA Clears Phase II Trial of Drug to Treat JC Virus

The pharmaceutical company Inhibikase Therapeutics has received a green light from the U.S. Food and Drug Administration (FDA) to conduct a phase II clinical trial on a drug to treat the JC virus. The authorization to do the study is significant because the JC virus causes a deadly brain disease that occurs in patients with compromised immune systems.

The trial is called a “proof of concept” trial.  “Proof of concept” trials are done in the early stages of human drug testing to see if the basic reason for the drug’s working and doing so safely can be substantiated.

The JC virus is a dormant virus living in between 80 to 90 percent of adults.  It remains harmless unless it is triggered by some assault on the patient’s immune system.  When this happens, the virus is activated, travels through the bloodstream to the brain, and begins to destroy brain cells. The disease it unleashes is called progressive multifocal leukoencephalopathy (PML).

PML kills most of its victims within 1 to 9 months. The average lifespan after diagnosis is 6 months.  Those who survive are left with significant neurological deficits.

The JC virus is activated, leading to PML, in patients with AIDS, HIV, and others with compromised immune systems, including people on chemotherapy for cancer, and patients receiving immunosuppressive drugs for organ transplants, rheumatoid arthritis, system lupus erythematosus, Crohn’s disease, severe plaque psoriasis, and multiple sclerosis.

The drug being tested is called Ik T-001.  If it succeeds in combatting the JC virus before the virus is activated and sets off PML, the drug would be a life saver for many patients with comprised immune systems and those on drugs to treat autoimmune diseases (diseases in which the immune system attacks the body).

Inhibikase Therapeutics was founded in 2008.  It is developing early-stage drugs to treat viral and bacterial diseases and opening new avenues for vaccine development and biodefense.

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