Oscotech’s SYK selective inhibitor’Sebidoplenib (SKI-O-703)’, which was called the’second lasertinib’ and raised expectations for technology transfer, was disappointed by the results of global phase 2 clinical trials. As a result, the stock price of Oscotech also declined sharply.
On the 7th, Oscotech announced that it did not achieve the primary evaluation index as a result of analyzing the Sevidoplenib Global Phase 2 Topline data with rheumatoid arthritis as an indication.
The primary evaluation index for the second phase is the change in the disease activity index (DAS) until week 12. Through hsCRP (high sensitivity C-reactive protein) test, the mean change in disease activity index (DAS28) for 28 joints was observed.
This means that Oscotek has not proved that the remission rate of sebidoplenib or the decrease in disease activity is significant through Phase II.
Since March 2019, Oscotech has been conducting Phase 2 of Sebidoplenib at 42 medical institutions in 7 countries including the United States and Europe. 163 patients who did not respond to the existing rheumatoid arthritis treatment methotrexate (MTX) and anti-TNF agents were administered a placebo group and a dose of sebidoprenib (100mg, 200mg, 400mg) twice a day for 3 months. Oscotech announced in September that it completed the phase 2 patient administration.
Regarding the results, Oscotek explained, “Many of the patients recruited were patients with severe rheumatoid arthritis, and due to the characteristics of these patient groups, it seems that all patients did not get the efficacy as expected.”
Also, as in phase 1, Oscotech revealed that no serious toxicity was observed at all doses in phase 2, thus securing excellent safety in actual patients.
With this result, Oscotech plans to participate in the JPMorgan Healthcare Conference starting on the 11th and hold meetings with multinational pharmaceutical companies as scheduled.
An official from Oscotech said, “In patients with severe or less severe rheumatoid arthritis identified through this test, we are looking to improve the efficacy by increasing the dose based on safety and treatment potential. In addition, additional studies on lupus, psoriasis and multiple vasculitis, which are known to be highly dependent on SYK, are in progress, and based on the final clinical report completed in the first quarter, additional clinical trials are being considered, including expansion of indications through dose increase.” .
Oscotech plans to release top-line data for the second phase of sebidoplenib for immune thrombocytopenia (ITP) at the end of this year.
Meanwhile, Oscotech’s stock price declined sharply on the same day as the results of the phase 2 clinical trial for rheumatoid arthritis did not meet expectations.
As of 11:30 on the day, the stock price of Oscotech was trading at 49,750 won, down 23.34% (15,150 won) compared to the previous trading day.