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 study submission for approval of the new active ingredient by the German Federal Institute for Drugs and Medical Devices (BfArM), subsequently the European Medicines Agency (EMA). Further approval steps are planned for the US FDA (Food and Drug Agency) and also for China.
The genetically formulated enzyme has been defined since 2019, and is protected by a patent.
The first batches of the active ingredient have been used as part of a proof of concept, and the effect of the enzyme has been documented in animal studies. The enzyme is characterized by a very high activity, which results in various advantages in the production process.
The project “BELACT” has been transferred to the next phase, which are steps for the approval of the active ingredient in human medicine. Out of the side of the German regulatory authority, we have had a dosier from Scientific Advice since Nov. 2021. In accordance with the Scientific Advice, we are using the information provided for the further implementation of the project. We will conduct the clinical studies I / II and III at the University of Bonn and University of Mannheim. Necessary documents and plans for production are heavy increasingly being processed since Feb. 2022.