AMG-634, what is the likelihood that the drug will be approved?

AMG-634 is under clinical development by Medicines Development for Global Health and currently in the Phase I and 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 AMG-634’s likelihood of approval (LoA) and phase transition for Erythema Nodosum Leprosum (ENL) took place on 30 Dec 2020, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 30 Dec 2020 decreased AMG-634’s LoA and PTSR for Inflammation.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their AMG-634 LoA and PTSR Report.

AMG-634 overview

AMG-634 is under development for the treatment of tuberculosis, erythema nodosum leprosum (ENL), immune reconstitution infl ammatory syndrome and unspecified indication with new spray dried dispersion formulation. The drug candidate is administered orally in form of capsules. It acts by targeting phosphodiesterase 4 (PDE4). It was also under development for discoid lupus erythematosus and subacute cutaneous lupus erythematosus and hemorrhagic fevers such as Junin, Lassa, Ebola and rift valley.

Medicines Development for Global Health overview

Medicines Development for Global Health (MDGHL) is an independent biopharmaceutical company that strives to develop and commercialize medicines and vaccines for unmet medical needs. The company’s pipeline clinical programs include Moxidectin, which is being developed for the treatment of river blindness and scabies; and RV-3-BB rotavirus vaccine, for prevention of rotavirus gastroenteritis in infants and neonates. It is also developing products which are in Phase I and II clinical development, for soil-transmitted helminthes, strongyloides and lymphatic filariasis. MDGHL is headquartered in Melbourne, Victoria, Australia.

Quick View AMG-634 LOA Data