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KDDF-201402-05 Development of SYK inhibitor for Rheumatoid Arthritis(Immunology, Chemical) [06.02.2014]

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Development and Market Objectives

SKI-O-703(mesylate salt of SKI-O-592) is currently under development as a preclinical candidate for the treatment of rheumatoid arthritis. SKI-O-592 inhibits spleen tyrosine kinase (SYK), which is a characterized drug target for autoimmune diseases.

Our market objective is to out-license SKI-O-703 to a global pharmaceutical company. Oscotec Inc. aims to conduct a phase I clinical trial in compliance with the US FDA based on existing data. Oscotec’s data reveals high selectivity, superior efficacy in in vivo models and a high-level of safety in rodents.

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 low 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.

Status

?The candidate SKI-O-703 is currently in preclinical development in preparation for an IND submission to the US FDA
- The preclinical study was completed at US CRO (2014). SKI-O-703 shows good Tox profile and excellent safety margin in rat and dog via oral administration (>30-fold margin of safety). 
- The IND application will be submitted in the third-quarter of 2015.

Intellectual Property

The legal groundwork has been laid for the development of SKI-O-592, which will protect its novelty and competitiveness. Key scaffolds are filed in the PCT application and in patent applications across 18 countries. Patent that includes SKI-O-592 has been filed for US and PCT patents.

Competitive Advantages

Rigel Pharmaceuticals, Inc. (CA, USA) has been developing an SYK inhibitor called R788. However, its documented clinical performance, both in terms of efficacy and adverse events, has fallen below expectations due to low selectivity. P505-15, from Portola Pharmaceuticals, Inc. (CA, USA) exhibits high selectivity, but the experiments have also revealed a high level of toxicity and low bioavailability.
 
The preclinical candidate SKI-O-703 demonstrates superior selectivity to SYK, improved bioavailability and a low level of toxicity. It has been established from in vivo models that SKI-O-592 and SKI-O-703 has better efficacy and safety characteristics when compared to existing SYK inhibitors. A leading pharmaceutical company has contacted Oscotec Inc. via an international conference. Currently, with a CDA in effect, publication strategies for the scientific data are being discussed.

Indication

Immunology  (Rheumatoid arthritis)

Research Period

May, 2014 ~ Aug., 2015

Company

Oscotec. Inc

Developmental Stage

Nonclinical

Additional Information

Contact Information

Contact
Address Company Name: Oscotec Inc.
WebSite Homepage: http://www.oscotec.com, www.genosco.com Contact Person: Ho-Juhn Song, Director of Genosco
E-mail: hsong@genosco.com Contact: 1-617-494-1460

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