Oscotec to Confirm Efficacy of 42 Trillion KRW Rheumatoid Arthritis Treatment in Q4... Technology Transfer Expected

SKI-O-703 Completes Recruitment of Target Patients for Global Rheumatoid Arthritis Phase 2a Trial
Dosage Completion Scheduled for Q3 and Clinical Efficacy Confirmation in Q4
Phase 2a Results Expected to Enhance New Drug Value and Technology Transfer Prospects

[Asia Economy Reporter Hyungsoo Park] OscoTech, a drug development company, announced on the 2nd that it has completed the recruitment of 148 target patients for the global Phase 2a clinical trial of Cevidoplenib (SKI-O-703), a selective SYK kinase inhibitor, for rheumatoid arthritis.

Cevidoplenib, OscoTech's new drug candidate that selectively inhibits the SYK kinase protein, began administration in April last year targeting rheumatoid arthritis patients who do not respond well to existing treatments. Patient recruitment was completed at a total of 42 hospitals, including 10 in the United States, 30 across 5 European countries, and 2 in Korea.

The drug is administered orally twice daily for 3 months in a randomized, double-blind manner with placebo, 100mg, 200mg, and 400mg doses. 98 patients have already completed dosing, and the last patient is expected to finish dosing around September. It is anticipated that clinical efficacy will be confirmed within the fourth quarter of this year.

The competing SYK inhibitor drug fostamatinib caused severe hypertension side effects, which limited the dosage and resulted in insufficient efficacy in Phase 3 clinical trials. Development as a rheumatoid arthritis treatment was abandoned. In contrast, SKI-O-703 selectively inhibits only SYK, and in Phase 1 trials involving single doses up to 800mg, once-daily doses of 200mg and 400mg, and twice-daily doses of 200mg for 7 days, no serious adverse events (SAEs), including hypertension, were observed. Excellent safety was confirmed. Pharmacodynamic tests in clinical trials also demonstrated superior efficacy.

In the Phase 2a trial, no drug-related adverse events warranting discontinuation, including hypertension, have been reported so far. Safety in actual patients is also being demonstrated. Efficacy evaluation for Phase 2a will be conducted using DAS28-hsCRP and ACR20/50/70 indicator analyses. This will be carried out alongside pharmacokinetic analysis after dosing ends in September.

By successfully completing the target patient recruitment, OscoTech expects to confirm drug safety and efficacy in the fourth quarter of this year.

According to the company, "The SKI-O-703 compound, developed as an autoimmune disease treatment, has demonstrated safety and efficacy indicators up to Phase 1 clinical trials and continues to show high safety even after completing multinational Phase 2a patient recruitment."

Additionally, "It is receiving continuous interest from multinational pharmaceutical companies," and "Once efficacy results in patients are confirmed, it will significantly enhance the new drug's value and meaningfully advance technology transfer negotiations," the company added.

Currently, it is estimated that about 1% of the global population has rheumatoid arthritis. The global rheumatoid arthritis treatment market is expected to grow 4-5% annually, reaching $34 billion (41.5548 trillion KRW) by 2025.

The Phase 2a clinical trial of the SYK inhibitor drug candidate SKI-O-703 was selected as a project under the Pan-Government New Drug Development Program in October 2018. It received 50% of clinical research funding support from the Pan-Government New Drug Development Project Group.