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MYR Pharmaceuticals — Treatment of HBV & HDV Infections

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MYR Pharmaceuticals is focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D virus infections.  MYR’s lead compound bulevirtide (Myrcludex), a first-in-class entry inhibitor for the treatment of chronic hepatitis B and D infections, progresses into a phase III clinical study for the indication of chronic HDV infection.

The drug specifically binds and inhibits the liver bile acid transporter protein NTCP on the hepatocyte surface, which was discovered to be the receptor for HBV and HDV infection of liver cells. Bulevirtide prevents the infection of healthy hepatocytes and viral spreading within the liver. Bulevirtide has shown an excellent safety profile and antiviral efficacy in several clinical trials. The drug has received Orphan Drug Designations for the treatment of HDV infection from the European Medicines Agency (EMA) and from the U.S. Food & Drug Administration (FDA). In addition, the EMA has granted PRIority MEdicines (PRIME) scheme eligibility - by this designation EMA offers early and proactive support for the development of medicines that target an unmet medical need.  In parallel the FDA has granted Breakthrough Therapy designation - a process designed to expedite the development and review of drugs which may demonstrate substantial improvements on a clinically significant endpoint. The British Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued the Promising Innovative Medicine (PIM) designation for MYR’s lead compound Bulevirtide (Myrcludex). 

MYR Pharmaceuticals has announced highly positive results from its MYR 202 clinical trial, a Phase 2b study investigating bulevirtide (Myrcudex)in chronic hepatitis delta infection. After 24 weeks of treatment bulevirtide demonstrated an excellent safety profile with no drug-related serious adverse events during the treatment period of 24 weeks and no treatment discontinuations due to the study medication. The primary endpoint, undetectable HDV RNA or decline of ≥2 log IU/ml HDV RNA to baseline, was met for all doses of bulevirtide, as presented during the 2018 EASL meeting in Paris.

During the AASLD meeting 2018 in San Francisco, USA, MYR Pharmaceuticals presented encouraging end of treatment data in HBV/HDV infected patients receiving bulevirtide monotherapy or in combination with pegylated interferon alpha 2a (PEG-IFNα2a) for 48 weeks (MYR203). Bulevirtide was well tolerated and no drug-related serious adverse events were reported during the treatment period of 48 weeks. Monotherapy with bulevirtide (2mg q.d.) demonstrated a continuous linear decline in serum HDV RNA levels and ALT reduction over 48 weeks. In contrast to (PEG-IFNα2a) monotherapy, a combination with bulevirtide and (PEG-IFNα2a) showed high rates of HDV RNA suppression (undetectable serum HDV RNA) in 50% of patients. Remarkably, combination therapy induced a HBsAg response defined as >1log IU/ml HBsAg decline with some patients achieving HBsAg loss during 48 weeks of treatment. The final results for the MYR203 study will be presented in the general session of The International Liver Congress 2019 (EASL) in Vienna, Austria on 13th of April 2019, at 10:00.

Present MYR203 data and clinical data from Phase 2a study in chronic hepatitis B patients (MYR201), indicate a potential role of bulevirtide in future HBV cure therapy regimens. Hence, MYR Pharmaceuticals is planning additional studies to further develop bulevirtide as a component of HBV cure treatment regimens.

In addition to hepatitis, bulevirtide has a potential for the treatment of a variety of inflammatory and metabolic diseases via additional pharmacological effects of NTCP inhibition. MYR Pharmaceuticals and its collaborators have obtained encouraging preclinical data that support further development of bulevirtide to treat dyslipidemia, nonalcoholic steatohepatitis (NASH), and primary biliary cholangitis (PBC). A Phase 1 clinical trial for dyslipidemia has been initiated.

MYR Pharmaceuticals is headquartered in Bad Homburg (Germany). The company started operations in 2011 and is supported by venture capital investors such as the High-Tech-Gründerfonds and Maxwell Biotech Venture Fund. The technology was originally developed at the University of Heidelberg (Germany) by Prof. Dr. Stephan Urban and INSERM (France) by Prof. Dr. Phillipe Gripon and represents one the most clinically advanced novel approaches for the treatment of hepatitis B and D.