Hepatera Ltd and its development partner MYR GmbH announced today the results of clinical trials investigating Myrcludex B in patients with chronic hepatitis B (HBV) and delta (HDV). The results suggest that Myrcludex B may become an option for treating hepatitis delta. With details to be presented at the AASLD meeting in Boston in November 2014, the trials also indicate positive results for the treatment of HBV infection.
A Phase 2a trial investigating effects of several Myrcludex B doses in 40 patients with chronic HBV infection showed that the drug was very well tolerated. A dose-dependent effect on HBV DNA was observed: >1 log10 HBV DNA decline at week 12 occurred in 6/8 (75%) patients receiving 10mg Myrcludex B while this occurred less often in the remaining dose groups (7/40; 17%). The HBV DNA response was maintained in 10mg patients through week 24.
In a Phase 2a trial in chronic HDV infection with 24 patients, Myrcludex B was investigated as monotherapy vs combination with pegylated interferon alpha for 24 weeks; a control arm received pegylated interferon alpha alone. Myrcludex B was very well tolerated both as monotherapy and in combination with interferon. Myrcludex B has shown strong single agent efficacy against HDV. 6 out of evaluable 7 patients experienced >1 log10 HDV RNA decline at week 24; 2 patients became HDV RNA negative and in further 2 the values dropped below the limit of quantification. In the combination arm, all patients had HDV RNA decline and 5 were HDV RNA negative at week 24. Importantly, ALT normalized in 4 Myrcludex B monotherapy patients at week 24.
“These results indicate biological activity of a non-interferon drug for the treatment of HDV infection which can represent a major breakthrough in the management of this most severe form of viral hepatitis”, said Heiner Wedemeyer, Professor of Hannover Medical School, Germany, and Chairman of MYR`s clinical advisory board.