REP-2165 is under clinical development by Replicor and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect REP-2165’s likelihood of approval (LoA) and phase transition for Hepatitis B took place on 22 Sep 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their REP-2165 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

REP-2165 overview

REP-2165 is under development for the treatment of hepatitis B and hepatitis B/hepatitis D co-infection. It is administered through an intravenous route. It is an oligonucleotide and targets hepatitis B virus surface antigen protein (HBsAg) in the HBV infected hepatocytes. The drug candidate is based on amphipathic DNA polymer (NAP) technology.

Replicor overview

Replicor is a biopharmaceutical company that develops and commercializes novel nucleic acid-based polymers (NAPs) for the treatment of patients with Hepatitis B and Hepatitis D. Its products under phase II clinical development include REP2139 and REP2165 for the treatment of Hepatitis B and Hepatitis D infection. Its NAPs therapy can be engineered with sequences, which retain antiviral activity that do not have pro-inflammatory activity or off target effects common with other oligonucleotide-based drugs. It uses NAP technology platform for preventing liver re-infection in patients with chronic hepatitis C. The company also provides therapeutic agents to eliminate HBV virus in the blood seroconversion for HBsAg and HBeAg, and serum HBV DNA; and reduce cccDNA levels in the liver. Replicor is headquartered in Montreal, Quebec, Canada.

Quick View REP-2165 LOA Data

Report Segments
  • Innovator
Drug Name
  • REP-2165
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Infectious Disease
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.