Hepcludex (bulevirtide) is the first medication for the treatment of hepatitis D, a virus blocker whose development had been masterminded by DZIF Professor Dr Stephan Urban of Heidelberg University Hospital. As early as the preclinical phase, the biotech start-up MYR Pharmaceuticals secured the exclusive licensing rights and took over the clinical development of the active substance to its approval by the European Medicines Agency EMA in July 2020. The US pharmaceutical company Gilead has now acquired MYR GmbH for a total of 1.45 billion euro – proof of the potential of this hepatitis D medication, developed with the participation of the German Center for Infection Research.
The German Center for Infection Research, which has dedicated itself to the translation of scientific insights into clinical practice, had at an early stage recognised the potential of continuing the development of the candidate active substance to its approval as a medication, and had become involved with the preclinical studies as early as 2012. “Two years later I was offered a DZIF professorship, presenting me with a unique opportunity as a research scientist to support the development of Hepcludex to market maturity at the University Hospital Heidelberg,” Professor Dr Stefan Urban explains.
For patients with hepatitis D, the company take-over opens up new and positive perspectives: Gilead specialises in the development and marketing of active substances for the treatment of various viral liver diseases (hepatitis B and hepatitis C). Hepcludex complements the portfolio of the US pharma giant with the indication of hepatitis D, for which there is an urgent medical need. Hepatitis D is considered particularly aggressive and can quickly lead to cirrhosis or cancer of the liver. For that reason, a liver transplant had until now often been the only treatment option offering patients a chance of survival. Clinical studies have shown that Hepcludex is well tolerated and highly effective in inhibiting the proliferation of hepatitis D viruses in the liver, resulting in a noticeable improvement in liver function.
A hepatitis D infection only occurs as a co-infection with the hepatitis B virus; hepatitis B and hepatitis D viruses share the same shell – the spot which Hepcludex attacks. Hepatitis B, too, is as yet incurable. In ongoing clinical studies, some patients were also freed from hepatitis B viruses under treatment with a combination of Hepcludex and interferon. This raises hopes for a further potential application of the active substance in a possible cure of hepatitis B.
Hepatitis D – an insidious infection
Hepatitis D is an inflammation of the liver triggered by the hepatitis D virus (HDV); its early symptoms provide no clear indication of this disease: Patients feel sick, suffer from a loss of appetite and a feeling of pressure in the upper abdomen. It takes a while for the characteristic jaundice to appear; the liver suffers increasingly severe damage, with a chance even of developing liver cancer.
Around 25 million people across the globe are estimated to be infected with HDV – hot spots are Mongolia, Pakistan, Russia, the Balkans, Brazil, Southern Italy, Central Africa and the Middle East. In Germany, hepatitis D occurs considerably more rarely. An estimated 6000 people are affected. According to the Robert Koch Institute, 59 new cases of hepatitis D were reported in 2018. The reason for this is that too few patients are being tested for the disease.