Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the cancellation of a Phase Ib/II study for its Category 1 genetic drug, STSG-0002, which is intended for the treatment of diseases related to hepatitis B virus (HBV) infection. STSG-0002 is a hepatic phagocytic replication-deficient recombinant adeno-associated virus that carries an shRNA sequence expression cassette targeting the P region and X region of the HBV genome.
Based on the results from the Phase Ia and Ib/II clinical trials, as well as long-term follow-up, STSG-0002 has demonstrated good safety and tolerability, with no adverse events of level 3 or above reported. After thorough communication with the primary investigator (PI) regarding the existing clinical trial data, it was determined that the preliminary efficacy data has not met expectations, and the benefits of continuing the investigational drug for subsequent subjects are considered limited. To minimize risk to the subjects, Staidson and the PI have jointly decided to terminate the clinical trial. Following the termination, the trial will be discontinued, and enrolled subjects will continue to be followed up long-term in accordance with the clinical trial protocol.- Flcube.com
