Header

CKD Pharmaceuticals, Inc(Pd No. : 3078664)

(Updated : Feb/03/2017)
product information
Model Nm
HS CODE 000000
M.O.Q
Ceritification
Keywords CKD Pharmaceuticals, Inc, CKD-506, an HDAC6 selective inhibitor
Seller ID CKDBD2017
  • SHARE


[Development of CKD-506, an HDAC6 selective inhibitor, for rheumatoid arthritis treatment]


[Development and Market Objectives]


•  CKD-506 initiate a phase 1 clinical trial to treat autoimmune diseases by repressing inflammatory cytokine and by inducing CTLA4 expression.



[Unmet Medical Need & Target Patients]


Target Patient Population Methotrexate or biologics-resistant RA patients


•   Rheumatoid arthritis (RA) is a chronic inflammatory disease which affects about 1% of

    world population. It usually results in severe joint pain and bone deformation.

•   The goal of RA treatment is to improve symptoms and slow the progress of the disease.

    The first line therapy is methotrexate. However, in short term use, about 30 to 40% of

    RA patients develop resistance against methotrexate. In long term use, 80% of RA

    patients develop the resistance.  

•   If the methotrexate treatment for 3 months does not improve the symptom, the RA

    patients are prescribed with the expensive biologics drugs such as Orencia (CTLA4-Fc)

    or other TNFα neutralizing agents. For the last 10 years, the biologics use increased

    gradually.

•   Some patients develop resistance against biologics drugs but the exact mechanism of

     resistance is unclear. One hypothesis of such resistance is anti drug antibody. It has

     been known that the anti drug antibody for about 30% of RA patients exposed to

     biologics reduces the efficacy of biologics due to the augmented clearance of the

     biologics.

•   CKD-506 represses inflammation synergistically with methotrexate by reducing TNFα

     secretion and inducing CTLA4 expression even in the presence of anti drug antibody

     against biologics. Thus, it is strongly believed that CKD-506 can be used for both

     methotrexate resistant and biologics resistant patients.


Unmet Medical Needs

•   Methotrexate may induce liver toxicity and methotrexate resistance as explained above.

•   The demand new oral small molecule drug is increasing to improve patient compliance

     (oral drug instead of IV injection) and to reduce high cost of biologics use

     (20,000USD/patients-year). 

•   Although tofacitinib, a new oral Jak3 inhibitor, was launched for the treatment of

    rheumatoid arthritis, it induces LDL cholesterol in a dose dependent manner (15%

    induction with 5 mg bid and 30% induction with 10 mg bid) and has an increased risk of

    carcinogenesis.

•   Other drug candidates such as p38 MAPK inhibitor or Syk inhibitor have been

    discontinued due to toxicity or lack of efficacy.

•   The demand on new oral small molecule drug is huge to enhance patient compliance

    and cost.



[Status]

 

- CKD-506 approved clinical phase 1 by Dutch regulatory authority (CCMO) at  Aug.2016.

- Phase 1 clinical trials will determine the drug safety in Europe based on non-clinical

   results.

- CKD-506 was found to be excellent to treat arthritis, such as through the decrease in joint

  edema and bone damage and a significant improvement in the inflammatory index of oral

  drug efficacy in animal testing of autoimmune disease.

- CKD-506 plans to conduct phase 2 clinical trials in 2017 upon completion of phase 1

  clinical tirals.

 


[Competitive Advantages]


•  Orally available small molecule drug that potentially replaces the current biologics.

•  Partnering Opportunity : Seeking for a global partner for development and

   commercialization 



Company Information

company information
Contact Person
Company CHONG KUN DANG PHARMACEUTICAL CORP.
Address
Homepage http://seller.buykorea.org/chong-kun-dang-pharmaceutical--EC095585
Tel 0221493000 Fax
Biz. Type Est. Year
Employees Annual Export USD 0~1 mn
Related Business Event List
Global Bio Pharma Plaza(GBPP 2017) 2017-11-27 ~ 2017-11-28
Innovation & Technology Business Partnering 2017 COEX Intercontinental, Seoul, South Korea 2017-03-29 ~ 2017-03-30
InnoMedi 2017-03-29 ~ 2017-03-29
Go to the top of the page
Loading...