Phase 2 trial targeting JC virus is cleared by the FDA

Inhibikase Therapeutics has received the go-ahead from the US Food and Drug Administration (FDA) to begin a phase II proof-of-concept trial of IkT-001, an inhibitor, targeting JC human polyomavirus (JCV) infection.

JCV infection, which is very common in the general populace, is a causative agent of Progressive Multifocal Leukoencephalopathy (PML). 

In MS’ers on Natalizumab, PML is fatal in more than 50 per cent of patients, as the JCV virus creates lytic infection of the brain. 
In pre-clinical models, however, IkT-001 was shown to be able to block JCV viral entry into host cells, suppressing the development of PML.

The phase II trial will be a four-week, open-label, multicentre, sequential dose-ranging study of the safety and pharmacokinetic profile of IkT-001 against JCV in 48 at-risk patients: those with relapsing multiple sclerosis (MS) who receive Tysabri (natalizumab) infusion therapy. 

The study will also examine the compound’s antiviral effect as measured by the urinary excretion of JCV.

PML currently has no approved treatment, meaning that IkT-001 will be eligible for orphan drug status if it continues to progress through trials to market. Additionally, as IkT-001 utilises a common mechanism of action that enables treatment for bacterial and viral infectious disease, an efficacious outcome in this phase II study could clear a path for multiple indications using the same pharmaceutical approach, according to Inhibikase.

Source: PMLive News

3 thoughts on “Phase 2 trial targeting JC virus is cleared by the FDA”

  1. "In MS'ers on Natalizumab, PML is fatal in more than 50 per cent of patients"PML fatal in more than 50% of patients? I thought the latest figures are 29 deaths in about 150 of those contracting PML after taking natalizumab. That's about 20% of those developing PML. Still, more than it should be so this is welcome news!

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  2. Re: "PML fatal in more than 50% of patients?"This figure refers to PML in general and not specifically to natalizumab-related PML, where the prognosis is better. In the latter the immune system is essentially intact so that when you wash-out the drug the cells can traffic to the brain and clear the virus. In the other conditions associated with PML the immune system is at fault and can't be reconstituted and is therefore associated with a poor prognosis.

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