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KDDF-201404-05 Clinical Development of Therapeutic Agent for Auto-Inflammatory Diseases(Immunology, Protein) [08.05.2014]

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Development and Market Objectives

Finishing phase 2 clinical trials for CAPS, getting approval, and licensing out to global company until 2020

Unmet Medical Need & Target Patients

Target Patients
CAPS(cryopyrin-associated periodic syndrome): NOMID(neonatal onset multisystem inflammatory disease), MWS(muckle-wells syndrome) and FCAS(familial cold auto-inflammatory syndrome)

 
Unmet Medical Need

No drug has been approved for the treatment of patients with CAPS in Korea. The patients with CAPS can be treated with Anakinra which is imported through Rare Disease Centre and covered by insurance. However the short half-life of Anakinra requires daily injections, leading to sometimes-painful injection site reactions.

 

There are currently two long-acting anti-IL-1β therapeutic proteins (Canakinumab and Rilonacept) that were approved for the treatment of CAPS. Although these drugs have been approved by the US FDA, these medicines may be too expensive for CAPS patients to afford them. 

 

Besides, it is uncertain whether these medicines could be imported to Korea.

 

HL2351(hIL1RA-hyFc) was developed to provide enhanced patient convenience by reducing dosing frequency. It is expected to fulfill unmet medical needs in the treatment of CAPS.

Status

A phase II clinical trial in patients with CAPS (cryopyrin-associated periodic syndrome) that was approved by Korean regulatory agency in Oct. 2015 is up and running. 

Intellectual Property

Number Registration number Register Patent Title Country Domestic/
Overseas
Registration Date
1 10-1333958 HANDOK INC Human interleukin-1 acceptor antagonist-hybrid F c fusion protein Korea Domestic Nov. 21, 2013
2 PCT/KR2011/007809 HANDOK INC Human interleukin-1 acceptor antagonist-hybrid F c fusion protein Overseas Overseas Oct. 19, 2011
3 8883134 HANDOK INC Human interleukin-1 acceptor antagonist-hybrid F c fusion protein US Overseas Nov. 11, 2014

Competitive Advantages

- Inhibits both Interleukin 1-alpha and Interleukin 1-beta.
- With new hybrid Fc technology, in vivo half- life of the fusion protein is increased, and safety and convenience for patients has been improved significantly by eliminating ADCC and CDC function while retaining fusion protein activity levels.

Indication

Immunology, Protein, CAPS

Research Period

Jul. 01, 2014 ~ Oct. 31, 2016

Company

HANDOK INC.

Developmental Stage

Phase 2

Additional Information

Contact Information

Contact
Address Company Name: HANDOK INC.
WebSite Homepage: http://www.handok.co.kr Contact Person: Medical Director Hyou Young Rhim
E-mail: HyouYoung.Rhim@handok.com Contact: +82-2-527-5336

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