Final report phase II
Final report of phase 2 study with VVX001 in chronic hepatitis B confirms positive preliminary data.
Viravaxx, a global leader in the development of antiviral products based on its innovative PCFiT® technology announced today that the final report of the phase 2 study VVX001-CS001 has become available. The report confirms the preliminary analysis performed earlier.
In this trial, four different cohorts were included and randomized 3:1 to either VVX001 or placebo: (1) vaccination naïve healthy subjects, (2) non-responders to conventional vaccination, (3) inactive HBV carriers and (4) patients on long-term treatment with direct antivirals. A total of 64 subjects participated in the trial.
The primary endpoint, significant elicitation of PreS specific IgG antibodies in actively treated subjects compared to placebo was achieved in all four cohorts. (p<0.001 in all cohorts and overall).
These antibodies were shown to inhibit HBV virus spreading in HepG2-NTCP cells in a cell culture model, which validates the virus neutralization capacity of the vaccination. HBV- neutralizing antibodies could be induced in non-responders to conventional vaccination. Encouragingly, more than half of the chronically infected patients in the study had a >50% reduction of serum HbSAg at 8 months after the end of treatment, which points to the potential of achieving a functional cure with a finite course of treatment with VVX001. On prolonged follow-up, a further decrease in some patients was observed.
Vaccination with VVX001 was safe and very well tolerated. Most importantly, direct antivirals could be safely stopped in most chronically infected patients after three VVX001 injections without a virus flare.
Walter Baumann, CEO of Viravaxx commented: „We are very happy that this final report confirms the efficacy of VVX001 in chronic hepatitis B, which is a major public health issue globally. We are now in active discussions with potential partners to bring this unique vaccine to the patients “.
This vaccine was developed together with the Medical University of Vienna with the team of Univ. Prof. Dr. Rudolf Valenta from the Center for Pathophysiology, Infectiology and Immunology as well as with Univ. Prof. Dr. Ursula Wiedermann, Univ. Prof. Dr. Petra Munda and Univ. Prof. Dr. Michael Trauner.