THERAPY & DRUG
We have developed a therapy that can be applied with our new drug. It is a special enzyme mixture developed for our BelACT therapy.
The various questions on feasibility, functional testing and implementation were proven in a number of individual cases and partly published.
The current project study was designed by the members of the PharmACT board of trustees for the necessary approval procedures.
The drug is produced exclusively in Germany using a genetic engineering process according to current production standards.
The technical and scientific principles are protected by patents. This enables us to offer a competitive product for many patients worldwide.
All in all, this is our basis for the submission of the study for approval of the new active ingredient by the European Medicines Agency (EMA), the approval process is prepared for US FDA (Food and Drug Agency) in parallel.
The manufacturing process of the developed enzyme mixture is finally determined and can be transferred to industrial production. The first lot of the medicine is ready to use since November 2019.
The team has planned the required steps in the veterinary and toxicology testing segments. The timeline for the testing will be completed during the first quarter of 2020. The study schedule for Phase 1 and related clinical documentation for each indication have been coordinated with the Clinical Research Organization in depth.
The submission process is expected to be completed during the Q1/2nd quarter of 2020. The clinical trials will be multi-centered in at least 2 sites in Europe; possibly also at one site in the United States.