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KDDF-201212-10 New drug development study for osteoporosis with novel mechanism(Metabolic Disorders, Chemical) [03.05.2013]

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Development and Market Objectives

Our aim is to develop a new drug for osteoporosis that actsthrough a novel mechanism targeting TAZ (transcriptional coactivator with PDZ-binding motif). This action triggers osteoblast proliferation and activation, while suppressing osteoclast activation. Research and development is currently underway to complete non-clinical and Phase II clinical trials (POC) using the candidate compound SP-35454. We then plan to initiate partnership with a global pharmaceutical company to jointly promote further development and commercialization.


 
Evidence of 10-day osteogenic effects in an OVX rat model of ageing, marked with tetracycline
 

Unmet Medical Need & Target Patients

Due to our aging society, the number of people suffering from osteoporosis has been rapidly rising. Approximately 40% of women and 13% of men over the age of 50 suffer from the condition. It is a serious disease with a 2.8% death rate, on par with breast cancer in the United States. The current medical need for osteoporosis treatment is a therapy that involves symmetrical bone formation and a deterrence of bone resorption, and preferably a convenient oral treatment rather than an injection, with no side effects.
The osteoporosis therapeutic market was worth $7.3 billion in 2010 and by 2015, it is projected to be worth around $11.4 billion., Approximately 1.5 million fracture patients are annually expected worldwide with resultant health expenditures totaling more than $30 billion.
 

Status

TAZ is a transcriptional modulator that promotes the differentiation of osteoblasts from mesenchymal stem cells. Our candidate SP-35454 activates TAZ, increasing ALP (a marker for osteoblast activation) and aiding calcium accumulation. 
After inducing osteoporosis in 6-month-old genetically-aged rats via OVX surgery, SP-35454 was orally administered for 4 months. Significant increases in bone density were detected in the 10 and 20 mg/kg treatment groups. In addition, the biomarkers ALP and osteocalcin were significantly affected, and increases in tetracycline double line gaps were observed, allowing us to detect bone growth in the thighbone and the shinbone. Further non-clinical research is currently underway.
 

Intellectual Property

Material patents: Application was lodged in 2011 (PCT)  
Patent scope: Worldwide (COM patent) entitled: Indenone derivative and pharmaceutical composition comprising same (patent number: WO2011/030955A1)
 

Competitive Advantages

      -      Superior remedial effect: As the treatment enables superior remedial effects in various animals with osteoporosis, we expect these results to be reflected in clinical testing.
-      Possibility of extended usage: SP-35454 controls differentiation of mesenchymal stem cells, which may enable the suppression of differentiation to fat cell. This may have applications in the treatment of obesity.
-      Safety: NOAEL was calculated at 500 mg/kg/day for the duration of the 4-week rat toxicity test. As a result, limited side effects and toxicity during clinical testing are expected.
-      Convenient usage: Our candidate is expected to retain remedial effects with a once-daily oral dosage.
-      Patent period: Related patent applications were submitted in 2011 with an expiration date of 2031, with further periods of validity possible.  

Indication

Osteoporosis

Research Period

Feb. 15th,2013 to Dec. 14th, 2014

Company

Shin Poong Pharm.

Developmental Stage

PreClinical

Additional Information

Contact Information

Contact
Address Company Name: Shin Poong Pharm. Co., Ltd.
WebSite Homepage: http://www.shinpoong.co.kr Contact Person: Lee Chul-Kyu
E-mail: cklee@shinpoong.co.kr Contact: +82-31-492-5789

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