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KDDF-201806-03 Development of SYK inhibitor for rheumatoid arthritis(Immunology, Chemical) [2019-09-27]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

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

The Phase I clinical study was completed at the CRO in USA (2018). SKI-O-703 were safe and well tolerated by healthy male and female subjects in single oral doses study and multiple oral doses study.

Our market objective is to out-license SKI-O-703 to a global pharmaceutical company. Oscotec Inc. aims to complete a phase IIa clinical trial at multiple sites in the US, Eastern Europe, and South Korea.

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: Active rheumatoid arthritis who have had inadequate response to csDMARDs or  biologics.

Status

The candidate SKI-O-703 is currently in global phase IIa clinical study.

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. 

Contact & Company Overview

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