Conestat alfa is under clinical development by Pharming Group and currently in Phase II for Acute Ischemic Stroke. According to GlobalData, Phase II drugs for Acute Ischemic Stroke have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Conestat alfa’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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. 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, coronavirus disease 2019 (COVID-19) associated acute respiratory distress syndrome, delayed graft function (kidney transplantation rejection), contrast-induced nephropathy, hemorrhagic shock and covid-19 pneumonia.

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.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.