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Drug Watch

Drugs in Development for Hepatitis Delta:

Drug

Mechanism

Company

Clinical Trial Phase

Designations

 Lonafarnib
 Prenylation Inhibitor
 Eiger BioPharma, USA
 Phase III          
 FDA Breakthrough Therapy Designation
 FDA Fast Track Designation
 FDA Orphan Drug Designation
 EMA Orphan Drug Designation
 EMA PRIME 
 Hepcludex (Formerly Myrcludex B)
 Entry Inhibitor
 MYR-GmbH, Germany (now part of Gilead)
 Phase III
 EMA PRIME
 FDA Breakthrough Therapy   Designation
 FDA Orphan Drug Designation
 Promising Innovative Medicine (PIM)   Designation by British MHRA
 Lambda (Pegylated Interferon)
 Immune Response   Stimulator
 Eiger BioPharma, USA
 Phase III Ready
 FDA/EMA Orphan Drug Designation
 FDA Fast Track Designation
 FDA Breakthrough Therapy Designation
 Ezetimibe
 NTCP Inhibitor
 Ziauddin University   Hospital,   Pakistan
 Phase II
 N/A
 REP 2139 - Mg (in combination with PEG-INF and Tenofovir)
 HBsAg Inhibitor
 Replicor, Canada
 Phase II

 

 N/A
 GI-18000
 Immune Response   Stimulator
 GlobeImmune, USA
 Pre-clinical
 N/A
Chart Updated August 2020

Glossary:
 

Terms: HBV = Hepatitis B, CHB = Chronic hepatitis B, HDV = Hepatitis delta virus, CHD = Chronic hepatitis D, PEG-INF = Pegylated interferon, NTCP = Sodium/taurocholate cotransporting polypeptide, FDA = U.S. Food and Drug Administration, EMA = European Medicines Agency, NIH = National Institutes of Health, British MHRA = Great Britain Medicines and Healthcare products Regulatory Agency


Lonafarnib

Lonafarnib is a "prenylation inhibitor" and works by targeting the protein assembly process, which prevents new viruses from being created. In a recent study, Lonafarnib combined with Ritonavir showed promise in reducing hepatitis delta virus levels. Lonafarnib is currently enrolling patients in Phase III clinical trials. It has been granted Fast Track Designation and Breakthrough Therapy Designation by the FDA, PRIME Eligibility Designation by the EMA, and Orphan Drug Designation by the FDA and EMA. 

Hepcludex (formerly Myrcludex B)

Hepcludex (generic name bulevirtide) is an “entry inhibitor” that works by stopping the virus from entering and infecting hepatocytes (liver cells), and breaking the cycle of reinfection. It has shown activity against the hepatitis B virus, and in July 2020 was approved by the European Commission for prescription in Europe, including Russia and the former Soviet Union, as the first effective Hepatitis D drug in the world. In September 2020, it was launched in Germany, France, and Austria. A study also showed promise for Myrcludex B (Hepcludex) when combined with PEG-INF in reducing hepatitis delta viral levels. Hepcludex is currently conducting Phase III clinical trials, which are no longer recruiting patients, partially to investigate the long-term effects of Hepcludex. It has been granted PRIME Eligibility by the EMA, Breakthrough Therapy and Orphan Drug Designation by the FDA, and Promising Innovative Medicine Designation by the British MHRA.

Pegylated-Interferon-Lambda (PEG-IFN-λ)

Pegylated-Interferon-Lambda is a type III interferon that works by activating the body's own immune system to fight the virus. A phase II study showed the ability of combination therapy with ritonivir and Lonafarnib to reduce hepatitis delta virus levels. PEG-IFN-λ has been granted Breakthrough Therapy and Fast Track Designation by FDA, and Orphan Drug Designation by the FDA and EMA.

Ezetimibe

Ezetimibe is currently being used as a treatment to lower cholesterol. Now being studied for effectiveness against hepatitis delta, it works by inhibiting NTCP, the receptor required for hepatitis delta to enter and infect liver cells.

REP 2139 and REP 2165 (REP-401 Protocol)

REP 2139-Mg is a "nucleic acid-based amphipathic polymer (NAP)" that works by preventing infected liver cells from releasing hepatiitis B virus into healthy liver cells. It is being evaluated for use in combination with PEG-IFN. Phase II study indicated that this combination treatment lowered HBsAg levels, HBV DNA and HDV RNA in some patients.

GI-18000

GI-18000 is an "immune response stimulator" that works by causing the host's T-cells to target and fight the infected liver cells.


For current clinical trials for hepatitis delta click here.

Updated December 2020