1. Drug Mechanism and Registration Category
RJV001 targets the extracellular matrix (ECM) to remove the support for the vitality of adipocytes, thus providing a novel mechanism of action to achieve remodeling of fat tissues. RJV001 will be a first-in-class biological drug for treating severe double chins in the United States and a Category 1 New Drug in China, after its regulatory approval.
2. Drug Efficacy
RJV001 dissociates adipocytes by digesting the connective collagens, leading to apoptosis of adipocytes and reduction of fat tissue volume. RJV001 is a modified Clostridium collagenase with intact Km value but reduced Kcat value by biochemical analysis. These results indicate RJV001 binds its substrate (collagen) with the same affinity as its wildtype counterpart but digests its substrate more slowly. Consistently, RJV001 effectively removes fat tissues after injected subcutaneously to fat tissues of obese mice and minipigs. Importantly, its effectiveness in fat remodeling is accompanied by minimum damage to the other tissues such as muscle and blood vessels around the injection site.
3. Drug Stability
RJV001 introduces one novel amino acid replacement. This changes not only produces a mild enzyme more suitable for therapeutic development, but makes the drug candidate more stable on shelf or in the presence of low concentrations of peptidase.
4. Drug Purity and Stability
RJV001 structure is protected by US and China patents, both owned by Rejuven Dermaceutical. It positions itself as the very first biological fat remodeling drug for medical esthetic applications globally. Compared to the collagenase products purified directly from the host Clostridium (for example, XIAFLEX), RJV001 exhibits the following advantages:
1) Single recombinant protein purified from E. coli;
2) Better quality control and manufacturing process;
3) Very high purity (over 98%) with better safety and stability profile;
4) Advantage in CMC for commercialization.