Amesanar is under clinical development by RHEACELL and currently in Phase III for Epidermolysis Bullosa. According to GlobalData, Phase III drugs for Epidermolysis Bullosa have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Amesanar’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.

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 that develops stem cell based drugs targeting inflammatory and degenerative diseases. It is investigating allo-APZ2 (allogeneic ABCB5-positive stem cells) against chronic venous ulcers (CVU), diabetic foot ulcers (DFU), recessive dystrophic epidermolysis bullosa (RDEB), and acute on chronic liver failure (ACLF). The company is also evaluating APZ2 (autologous ABCB5-positive stem cells) for CVU; and LSC2 (limbal stem cells), a regenerative medicine to treat limbal stem cell deficiency (LSCD). RHEACELL utilizes ABCB5-positive (ABCB5+) mesenchymal stem cells platform technology to develop its drugs. It works in collaboration with scientists and clinicians. 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.


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.