Preclinical pharmacology work for DT-109 has been completed (Publications). A DT-109 efficacy and genomics study in non-human primates has also been completed and is being submitted for publication in the summer of 2022. We also plan to initiate DT-109 IND enabling studies in 2022 with filing of the IND application in 2023, with co-development in the US and China.
The Chinese FDA has approved Beijing SL’s IND application and the first patient has been dosed in China. Due to a high level of clopidogrel resistance and the medical need for a reliable anti-platelet therapy, DT-678 has received a breakthrough designation status in China. We plan to file the DT-678 IND in the US in early 2023.