On November 6, 2009, AiCuris announced that it had successfully completed three phase I studies with its new compound AIC316. AIC316 is a new treatment for herpes simplex virus infections that is in the class of helicase-primase inhibitors. Helicase-Primase Inhibitors (HPI) prevent viral DNA from unwinding which in turn leads to the virus being unable to replicate.
The study involved more than 120 volunteers. Each participant was exposed to a single-dose, multiple-dose, or food interaction study. The study had favorable results with few side effects and long-lasting exposure among participants and will now move forward to phase II of the drug trial. Professor and CEO of AiCuris, Dr. Helga Rubsamen-Schaeff states, "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.”
AiCuris' strategy differs from previous herpes treatments as it focuses on antibacterial and antiviral substances that only have resistance-breaking properties. In this regard, AiCuris believes AIC316 could become a novel chemical class namely due to the way it differs from other available treatments of herpes simplex. Dr. Manickam Rangaraju, CMO of AiCuris, further purports, "Our compound has the potential to become a next-generation therapy for episodic and suppressive treatment of herpes simplex virus infections." He goes on to explain that “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.”
Clearly there is a need for a more efficacious treatment of the herpes virus; one that is well-tolerated and provides resistance-breaking treatment options. Will AC316 be the new herpes treatment option of tomorrow? We will only know once the full drug trial is complete. Phase 2 studies will begin in April 2010 in Washington, Oregon, Utah, Texas and Indiana. For more information about the trial go to clincialtrials.gov.