THERAPEUTIC SOLUTIONS AND MEDICINES
Our therapy is built around an innovative, biotechnologically engineered enzyme that specifically targets and breaks down harmful endogenous deposits.
The enzyme’s efficacy has been demonstrated through a preclinical proof-of-concept study conducted by Charles River Labs, USA, confirming its potential.
We are actively working towards obtaining approval for this novel treatment as a drug for familial hypercholesterolemia and other high-need indications, positioning us for significant market impact.
PROJECT „BELACT“
The BELACT project was developed with the expert oversight and endorsement of Pharmact’s Scientific Advisory Board and serves as the foundation for the initiation of the required regulatory approval pathways. In simple terms, the project involves three main steps: the production of multiple enzyme batches, standardized animal studies, and subsequent clinical trials.
The active ingredient is manufactured using cutting-edge genetic engineering techniques, adhering to current regulatory and production standards, with all production taking place at our German facility.
The scientific and technological innovations underpinning the project are protected by patents, which safeguard the foundation for competitive international commercialization of the drug, with the potential to address a wide global patient population.
This process supports our submission for approval of the new active substance with the European Medicines Agency (EMA), while we are concurrently preparing for the regulatory submission to the US FDA.
PROJECT PROGRESS
The enzyme manufacturing process is fully defined and ready for large-scale production. The first batch has been successfully used for preclinical efficacy validation.
With additional production batches available, we are now preparing for standardized animal studies and toxicological assessments.
The study design has been finalized in consultation with regulatory authorities, structured into clear milestones, and is set for execution. Clinical trials (Phases I/II/III) are prepared and have been entrusted to two leading university hospitals for multicenter implementation.
The submission process is in progress, ensuring that clinical trials will be conducted at multiple locations.
Our goal is to potentially secure regulatory approval in the US in partnership with a strategic partner, and preparations are well underway.