How DM199 Stands Out
We believe DM199 may provide new treatment options with significant benefits over the current standards of care. In the treatment of AIS, DM199 is being tested with up to a 24 hour treatment window from the onset of a stroke, potentially providing a treatment option in the United States for the approximately 80% of AIS patients currently receiving only supportive care. In the treatment of CKD, we believe that DM199 has the potential to maintain, or possibly restore kidney function, by both improving blood flow (as measured by eGFR) and reducing albuminuria (as measured by the urinary albumin to creatinine ratio). We are not aware of any approved therapies in the United States or the European Union to address low KLK1 levels. To date, clinical trials have been and/or are being conducted in the United States, Europe and Australia. In these studies, DM199 has consistently demonstrated excellent safety and tolerability with no treatment-related serious adverse events (SAEs).
DM199 also has distinct advantages over existing KLK1 replacement therapies. KLK1, primarily derived from human urine, is widely used in China (marketed under the brand name Kailikang® by Shanghai Pharma) for the treatment of AIS, and we estimate that over 600,000 patients have been treated since its introduction in 2005. We believe that DM199, a synthetic form of KLK1, administered subcutaneously could result in improved efficacy with more stable pharmacokinetics (drug level exposure) while avoiding the potential side effects of Kailikang, specifically the risk of endotoxins, impurities and antibody formation associated with Kailikang given that it is isolated from human urine. DM199 also addresses potential supply constraints that makes Kailikang difficult and expensive to produce given the limited source of human urine. We believe these factors make the recombinant protein DM199 a product candidate that is better positioned for regulatory approval worldwide compared to a urine-derived protein since it can meet the rigorous manufacturing standards required by modern regulatory agencies.