Conestat alfa is under clinical development by Pharming Group and currently in Phase II for Contrast Induced Nephropathy. According to GlobalData, Phase II drugs for Contrast Induced Nephropathy does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Conestat alfa LoA Report. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Conestat alfa overview
Conestat alfa (Ruconest/Rhucin) is the first recombinant analogue of the human C1 esterase inhibitor (rhC1INH) produced by recombinant DNA technology in the milk of transgenic rabbits.The amino acid sequence of conestat alfa is identical to that of endogenous C1INH. It is formulated as a powder for solution injection for intravenous administration. It is indicated for the treatment of acute attacks of angioedema in adults and in children with hereditary angioedema (HAE) due to deficiency of c1 esterase inhibitor.
Conestat alfa is under development for the treatment of prophylaxis of hereditary angioedema, prevention of acute ischemic cerebral and renal events after transcatheter aortic valve implantation, delayed graft function (kidney transplantation rejection), contrast-induced nephropathy, hemorrhagic shock and coronavirus disease 2019 (COVID-19) associated acute respiratory distress syndrome and covid-19 pneumonia. The drug candidate is administered through intravenous, intramuscular, intradermal and subcutaneous routes. It was under development for the treatment of acute pancreatitis, acute kidney injury and pre-eclampsia.
Pharming Group overview
Pharming Group (Pharming) develops precision medicines and innovative protein replacement therapies for the treatment of rare diseases and unmet medical needs. The company’s marketed product includes, Ruconest (conestat alfa), a recombinant human C1 inhibitor is used for the treatment of acute hereditary angioedema (HAE) and has been approved in the US, the UK, Europe, Israel, and South Korea. Its product pipeline consists of leniolisib for treatment of activated phosphoinositide 3-kinase delta syndrome (APDS); a-Glucosidase for the treatment of Pompe disease. The company markets its products through own sales force and network of distributors and partners. Pharming is headquartered in Leiden, the Netherlands.
For a complete picture of Conestat alfa’s drug-specific PTSR and LoA scores, buy the report here.