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KDDF-201509-05 Development of SYK inhibitor for Rheumatoid Arthritis(Immunology, Chemical) [01.22.2016]


Development and Market Objectives

SKI-O-703 (mesylate salt of SKI-O-592) is currently under Phase I clinical studies for the treatment of rheumatoid arthritis in USA. SKI-O-703 inhibits spleen tyrosine kinase (SYK) which is well known as a characterized drug target for autoimmune diseases.

The preclinical study was completed at the CRO in USA (2015). SKI-O-703 showed a good Tox profile and excellent safety margins in rat and dog via oral administration (>30-fold margin of safety).

Our market objective is to out-license SKI-O-703 to a global pharmaceutical company. Oscotec Inc. aims to complete a phase I clinical trial in compliance with the US FDA.


Unmet Medical Need & Target Patients

Unmet medical needs:

Low molecular weight drugs from the DMARDs family are the current gold-standard for treatment of rheumatoid arthritis. However, they suffer from low efficacy, frequent cases of non-responsiveness and a variety of adverse events.

Biologics often exhibit reasonable efficacy, but many patients are non-responsive to them. Moreover, high costs, limited administration routes (injection is the only validated administration route) and potential tumor formation are points of concern in using biologics for anti-rheumatic applications. Therefore, the key unmet needs for rheumatoid arthritis medicines are summarized as follows:

1) Achievement of adequate therapeutic efficacy for patients who are non-responsive to existing medicines,

2) Management of adverse events to a lower level coupled with high selectivity,

3) Maintenance of economic feasibility through low molecular weight synthetic drugs,

4) Improvement in convenience via oral administration.


Target patient population: Patients with rheumatoid arthritis, those who are non-responsive to MTX and biologics.


The candidate SKI-O-703 is currently in phase I clinical study in compliance with the US FDA.

Intellectual Property

The legal groundwork has been laid for the development of SKI-O-592 (free base of SKI-O-703), which will protect its novelty and competitiveness. Patents for key scaffolds were filed in US and 18 countries following PCT application and some of those including US were registered. A patent that includes SKI-O-592 has been filed for US and PCT patents.

Competitive Advantages

Fostamatinib (R788) developed by Rigel Pharmaceuticals, Inc. jointly with AstraZeneca was discontinued after Phase III clinical trials due to low efficacy and severe adverse events which were caused from low selectivity. P505-15, from Portola Pharmaceuticals Inc. exhibited high selectivity, but revealed a high level of toxicity and low bioavailability.


Our clinical candidate SKI-O-703 demonstrated a superior selectivity to SYK, an improved bioavailability and a low level of toxicity. It has been established from in vivo models that SKI-O-703 has better efficacy and safety characteristics when compared to existing SYK inhibitors. We are currently in contacts with global pharmaceutical companies for future out-licensing. 



Research Period



Oscotec Inc.

Developmental Stage


Additional Information

Contact Information

Address Company Name: Oscotec Inc.
WebSite Homepage: Contact Person: Hae-Jun Hwang
E-mail: Contact: +82-31-628-7666

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Related Project
Development of SYK inhibitor for Rheumatoid Arthritis Project view