May 11, 2013 Grand Hotel Bristol, Stresa, Italy
Host-Targeted Antiviral Validated to Block Patient-Derived JC Virus
Atlanta, GA – April 25, 2013 – Inhibikase Therapeutics, Inc., an emerging leader in infectious disease, announced today that it will update the scientific and medical community on the development program for IkT-001Pro. IkT-001Pro, a host-directed tyrosine kinase inhibitor in an extended release formulation, is intended to clear JC polyomavirus (JCV) infection, the causative agent of Progressive Multifocal Leukoencephalopathy (PML). The Company will demonstrate the effectiveness of IkT-001Pro against patient-derived JCV isolated from the urine of patients chronically infected with virus, the first time a direct measure of antiviral potency against patient-derived virus has been possible. A preliminary insight into clinical efficacy of the proposed therapy will also be presented, linking mechanism of action to direct control of virus in patients.
JCV infection progresses to PML only in patients with chronic or drug-induced immune suppression, to include patients diagnosed with clinical AIDS or who are receiving monoclonal antibody treatment for MS, lupus, rheumatoid arthritis, leukemia or lymphoma. IkT-001Pro is projected to clear the patient of chronic JCV infection prior to its transformation and entry into the brain, thereby acting as a form of preventative therapy for AIDS patients and/or patients on immunosuppressive therapy.
“The ability to isolate and replicate patient-derived virus and demonstrate antiviral potency for IkT-001Pro validates the mechanism of action of this medication against the viral infection that actually afflicts patients. Combined with a preliminary clinical readout, Inhibikase may have found a path to control of PML development in at least some patients. While further clinical evaluation will take place over the next three months, the Company is cautiously optimistic that it has found a way to control JCV,” said Milton H. Werner Ph.D., Chief Executive Officer and President of Inhibikase Therapeutics. “The common mechanism of action utilized by IkT-001Pro enables treatment for bacterial and viral infectious disease, and the application of this medication could be suitable for many types of infections through a common mechanism of action.”
About JC Virus and Progressive Multifocal Leukoencephalopathy (PML)
The John Cunningham virus (JCV) is a type of human polyomavirus. It was isolated in 1971 from a patient with progressive multifocal leukoencephalopathy (PML). Human polyomaviruses, like JC and BK, cause PML and other diseases only in the context of immunodeficiency, as in AIDS, or drug-related immune suppression, either for treatment of autoimmune disease, cancer or for solid organ transplant maintenance. JCV infection is very common in the general population, with roughly 60 percent of adult humans likely to have been exposed to the virus; most people acquire JCV in childhood or adolescence. (1) When immunodeficiency or immunosuppression allows JCV to ‘reactivate’, the virus preferentially migrates to the brain, destroying oligodendrocytes and astrocytes. This lytic infection leads to cognitive and motor dysfunction (the syndrome PML) and is fatal in 50 percent or more of patients. The best approach to treating the disease is to attack the virus before it enters the brain. IkT-001Pro blocks viral entry into host cells, and therefore could suppress an active JCV infection in at risk patients prior to virus migration into the brain. There is no currently approved treatment for PML.
About Inhibikase Therapeutics
Founded in 2008, Inhibikase Therapeutics is a private specialty pharmaceutical company developing novel, small-molecule compounds to treat bacterial and viral infectious diseases. Its pipeline of validated targets utilizes known chemical entities, as well as novel chemical entities, to treat diseases therapeutically and prophylactically. By inhibiting human pathways used by multiple bacteria and viruses for reproduction in the patient, the Company’s compounds block viral and bacterial reproduction with a lower likelihood of stimulating resistance. Inhibikase Therapeutics is also developing a broad-spectrum antiviral specific for enveloped viruses, opening new avenues for vaccine development and biodefense. For more information, please visit the Company’s website at www.inhibikase.com.
(1) Padgett, B.L. and Walker, D.L. (1973). “Prevalence of antibodies in human sera against JC virus, an isolate from a case of progressive multifocal leukoencephalopathy”. J. Infect. Dis. 127 (4): 467-470.