AiCuris successfully completed phase I for novel herpes compound

10-Nov-2009 - Germany

AiCuris announced that three phase I studies with its novel compound AIC316 for the treatment of herpes simplex virus infections have been completed successfully. AIC316 is a first-in-class helicase-primase inhibitor.

More than 120 volunteers were exposed in single-dose, multiple-dose and food interaction studies. The drug was generally well-tolerated and showed high and long-lasting exposures in the human subjects.

"We now have all data to enter into phase II, and we are pleased to have obtained evidence for favourable pharmacokinetics of AIC316 which will allow a convenient dosing regimen in patients”, said Prof. Helga Rübsamen-Schaeff, CEO of AiCuris. “According to AiCuris’ strategy to focus on antibacterial and antiviral substances with resistance-breaking properties only, AIC316 represents a novel chemical class and has a mode of action which is different from the drugs currently available for the treatment of herpes simplex.”

“From what we have observed so far, our compound has the potential to become a next-generation therapy for episodic and suppressive treatment of herpes simplex virus infections”, explained Dr. Manickam Rangaraju, CMO of AiCuris. “With current herpes therapies, suppression of viral shedding in genital herpes and hence prevention of disease transmission is not sufficiently achieved. Furthermore, resistance may develop upon long-term use in immune compromised individuals. Therefore, there is a need for more efficacious, well-tolerated as well as resistance-breaking treatment options. Such drugs should also offer benefits with respect to ease of administration.”

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