![[BioS]Oscotech,’SYK inhibitor’ for rheumatoid arthritis, phase 2 “first not reached”](https://img.etoday.co.kr/pto_db/2021/01/20210107083509_1565309_591_386.jpg "[BioS]Oscotech,’SYK inhibitor’ for rheumatoid arthritis, phase 2 “first not reached”")
Sebidoplenib’s primary evaluation index failed…”Severe patients with less than severe doses, some efficacy in high dose group”
Oscotec announced on the 7th that it failed to achieve the primary evaluation index as a result of analyzing the topline data for phase 2 clinical trials of rheumatoid arthritis of the SYK inhibitor’SKI-O-703′.
This phase 2 clinical trial was conducted on patients who did not respond to methotrexate (MTX) and TNF drugs, and the majority of the recruited patients were patients with severe rheumatoid arthritis. Oscotek said, “Due to the characteristics of the patient group, sebidoplenib does not appear to have as much efficacy as expected in all patients.”
Drug exposure was relatively low in patients compared to phase 1 clinical trials in healthy subjects. In addition, no serious toxicity was observed at all doses.
Oscotech said, “We expect to improve efficacy by increasing the dose based on safety and the possibility of treatment in patients with less severe rheumatoid arthritis identified through this test.” “In addition, lupus, psoriasis, and Further research is also underway. Based on the final clinical report completed in the first quarter, we are considering additional clinical trials, including expansion of indications through dose increase.”
On the other hand, it is in the process of Phase 2 clinical trials for the immune thrombocytopenia (ITP) of sebidoplenib, and the efficacy and safety will be announced through top-line data at the end of this year.