Hepatitis B virus under electron microscope. Credit: Sanofi Pasteur via Flickr.

German drug development company AiCuris Anti-infective Cures has reported positive results from the Phase I clinical trial of AIC649 for the treatment of chronic hepatitis B (CHB).

Data obtained during the multi-centre trial showed a single intravenous dose of AIC649 to be safe and well-tolerated in all dose groups.

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AIC649 is designed using inactivated parapoxvirus particles to trigger a natural, self-limiting immune response. This is intended to maximise the required immune responses against unrelated viruses.

The immunomodulator activity of AIC649 is said to possess the potential to act as a functional cure for hepatitis B virus (HBV) infection.

AiCuris performed the randomised, double-blind, placebo-controlled Phase I trial to evaluate the safety, tolerability and pharmacodynamics of intravenous AIC649 doses in a total of 32 chronic hepatitis B patients.

“These results from a first-in-human clinical trial are very encouraging.”

Across the four ascending-dose groups in the trial, subjects were administered with single AIC649 dosages or placebo. The participants were then monitored for 84 days.

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The chronic hepatitis B candidate did not demonstrate any dose-limiting toxicity. In addition, its highest administered dose did not reach the maximum tolerated dose.

AiCuris further reported that the heterogeneity of the trial subjects did not affect the stimulation of the patients’ immune system when given a single dose of AIC649.

AiCuris Anti-infective Cures CEO Holger Zimmermann said: “These results from a first-in-human clinical trial are very encouraging.

“They clearly support our commitment to progressing the clinical development of AIC649, a promising candidate from our broad development pipeline of anti-infective compounds with the potential to induce functional cure in HBV-infected patients.”

The company is currently working towards increasing the production of AIC649 for future clinical trials.

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