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The problem and market of osteoporosis

Global osteoporosis market to reach $11.2bn by 2027

The problem

1 Poor diagnosis of the disease

2 Low disease awareness

3 Each year the U.S. spends nearly $17 billion treating

4 The majority of the drugs available in the current market belong to the anti-resorptive drugs category

5 The unmet need for osteoporosis therapeutics is estimated to be worth approximately $3.3 billion.

The market analysis
시장현황
The drug category
Category Anti-resorptive drug Bone forming drug
Example Bisphosphonates (alendronate) Teriparatide
Mechanism Inhibit osteoclast activity Enhance osteoblasts activity
Side Effects -Esophagous problems
-Osteonecrosis of the jaw
-Hypocalcemia
-Unusual thigh bone fracture
 -Osteosarcoma after ong term use
-Hypercalcemia


시장현황2

NIBEC solution for osteoporosis

In contrast, our NIPEP-OSS is the only alternative to PTH in bone regenerative strength with less concern of sarcoma. The NIPEP-OSS is fast in distribution toskeletal tissue, bone and increase the bone formation signal transduction. This is first-in class osteogenic agent with broad safe margin.

NIPEP-OSS Druggability

NIPEP-OSS Induces human like Bone formation

The effect of NIPEP-OSS on osteoporosis

NIPEP-OSS Non-clinical toxicity test

Non-clinical toxicity test

The drug category
Test Administration route Dose (mg/kg) Result
hERG assay in vitro 300, 1000μM IC50> 1000μM
Mouse neurological effect (IRWIN test) SC injection 0, 250, 500, 1000 NOAEL=1000mg/kg
Monkey cardioheamodynamic effect (Telemetry) SC injection NOAEL=1000mg/kg
mouse pulmonary effect (Plethysmography) SC injection NOAEL=1000mg/kg

NIPEP-OSS Clinical study

Phase 1 Study: IND submission clinical study in Korea, 2019

Dental bone regeneration and spinal fusion purposeOssGen-X15®

  • World's first bioactive peptide combined biomaterial regarded as medical device
  • World's first bioactive peptide combined biomaterial regarded as medical device
  • Via OssGen-X15 data, the safety and efficacy of NIPEP-OSS for bone regeneration were demonstrated in 72 patients clinical study
  • 20mg NIPEP-OSS in 0.25g bone graft, single implantation at the defect site, active bone regeneration
  • Current status: KFDA approved, CE and FDA in progress