Amesanar is under clinical development by RHEACELL and currently in Phase II for Diabetic Foot Ulcers. According to GlobalData, Phase II drugs for Diabetic Foot Ulcers 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 Amesanar 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.
Amesanar overview
Amesanar (Allogeneic ABCB5-positive mesenchymal stem cells) is acting on chronic non-healing wounds in humans. It is formulated as solution for subcutaneous route of administration. Amesanar is indicated for chronic venous ulcers on the basis of an existing chronic venous insufficiency (CVI).
Allo-APZ2 is under development for the treatment of chronic venous ulcer (CVU), diabetic foot ulcer (DFU) and recessive dystrophic epidermolysis bullosa (RDEB). It is administered through intramuscular, intravenous and cutaneous routes. The therapeutic candidate comprises of skin-derived ABCB5-positive mesenchymal stem cells isolated from skin tissue of healthy donors (allogeneic ABCB5-positive stem cells). It acts by targeting ATP-binding cassette sub-family B member 5 (ABCB5).
It was also under development for the treatment of acute kidney injury, acute-on chronic liver failure (ACLF) and peripheral artery occlusive disease.
RHEACELL overview
RHEACELL is a biopharmaceutical company. It develops stem cell based drugs targeting inflammatory and degenerative diseases. The company offers amesanar a stem cell drug to treat ulcers. Its pipeline products include Recessive dystrophic epidermolysis bullosa, non healing chronic venous wounds in recruiting stage, Non-healing diabetic foot ulcers in setup stage, Polycystic kidney disease, Acute graft-versus-host disease and Transplant rejection in rejection stage. RHEACELL is headquartered in Heidelberg, Baden-Wurttemberg, Germany.
For a complete picture of Amesanar’s drug-specific PTSR and LoA scores, buy the report here.
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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.
