AiCuris Reports Positive Phase 1 Trial Results w/ Immunomodulator AIC649

[aov77]

http://mobile.dgap.de/dgap/News/corporate/aicuris-reports-positive-phase-clinical-trial-results-with-immunomodulator-aic-patients-with-chronic-hepatitis-b/?newsID=1093491


AiCuris Reports Positive Phase 1 Clinical Trial Results with Immunomodulator AIC649
in Patients with Chronic Hepatitis B

Single intravenous dose phase 1 trial showed that AIC649 was safe and well tolerated in all dose groups
The trial provides evidence that AIC649 stimulates the immune system of chronic hepatitis B patients
Further trials to study the potential of AIC649 to induce a functional cure in chronic hepatitis B virus (HBV)-infection is warranted
Wuppertal, Germany, September 3rd, 2018 - AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs targeting infectious diseases, announced the results from its first-in-human, single-ascending dose clinical phase 1 trial with AIC649 in patients suffering from chronic hepatitis B (CHB).

The randomized, multi-center, double-blind, placebo-controlled phase 1 clinical trial was designed to assess the safety, tolerability and pharmacodynamics of single ascending intravenous doses of AIC649 in CHB patients. Thirty-two patients were randomized in four ascending dose groups. Patients in each group received either single dosages of AIC649 or placebo and were monitored for 84 days. The majority of the patients were male, HBeAntigen (HBeAg)-negative, and HBV treatment naive.

A single intravenous dose of AIC649 was safe and well tolerated in all dose groups. There was no dose limiting toxicity and the maximum tolerated dose was not reached with the highest dose administered. Despite the heterogeneity of the patients in the trial, there was evidence that a single dose of AIC649 stimulates the patients' immune system as shown by increases in plasma levels of immune-regulating cytokines including IL-1β, IL-6, IL-8 and IFN-γ and reductions in IL-10 levels.

"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," said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH. "We are now preparing the production for further clinical trials with AIC649."

In a previous study in a woodchuck animal model of CHB, treatment with AIC649 induced a unique bi-phasic response pattern, and, in combination with Entecavir, led to a sustained loss of woodchuck hepatitis virus (WHV) DNA and surface antigen (WHsAg). The observed sustained loss of WHsAg and the induction of anti-WHsAg antibodies accompanied by cell mediated immune responses support the hypothesis that AIC649 induces a physiologically "concerted", reconstituted immune response to WHV[1], suggesting that AIC649 treatment may lead to functional cure in CHB patients.