The need for development of new drug
for diabetic neuropathy
-
- No special treatment for diabetic neuropathy
- Low pain reduction effect due to combined use of
anticonvulsant and antidepressant drugs
(effective in less than 30% of patients)
-
Problems of existing treatments
- Inability to administer high doses due to low
safety margin
- Side effects in central nervous system such as dizziness
and drowsiness
- Possibility of substance abuse
- Restriction of co-administration with other drugs due to drug interactions
Characteristics of
the target drugs
- It is expected to show excellent analgesic effect in diabetic neuropathy patients with excellent efficacy.
- Expected to have minimal side effects compared to existing drugs
Excellence of FB118B1
Competitiveness of FB118B1 Synthetic New Drug
-
Diabetic Neuropathy Pain Model
-
RAW264.7 cell LPS inflammation model
FB118B1 : Pain suppression to “normal”
Competitiveness of FB118B1
Competitiveness of
FB118B1
-
Specialty
New MoA
Inhibition of HCN and NaV
Broad indications
When compared
with Gabapentin
Fewer side effects
Less sedation and dizziness
than gabapentin
-
Marketability
Big Market Size
About $4.8 billion
CAGR
6.6%
(Credence Research; 2018)
-
Monopoly
Material patent
Secured intellectual
property rights
Acquisition of global rights
The need for development of new drug
for diabetic nephropathy
-
- No appropriate treatment for diabetic nephropathy (Bardoxolone methyl was discontinued during phase 3 clinical trials due to increased cardiovascular disease)
- Pirfenidone is used for various fibrosis, but its efficacy is not good
- Side effects of existing treatments: increased incidence of cardiovascular disease
Characteristics for
the taget drugs
- Excellent efficacy and minimal side effects for renal glomerular fibrosis caused by diabetic nephropathy are expected
- Drugs without a high risk of developing cardiovascular diseases such as heart failure in clinical practice,
- FB216A1-1 has no cardiovascular side effects.
Competitiveness of FB216A1-1
(Efficacy and MoA)
-
Treatment of “renal fibrosis” through “inhibition of
the expression
of a specific protein (FSP-1)”
by FB216A1-1
Animal Experiment
Renal fibrosis to a “normal” level
-
Treatment of “renal fibrosis” through “inhibition of collagen production” by FB216A1-1
Animal Experiment
Renal fibrosis to a “normal” level
-
Treatment of “renal fibrosis” through “inhibition
of connective tissue
growth factor
(CTGF) activity” by FB216A1-1
Cell Culture
The levels of renal fibrosis-related
factors were reduced to normal
The need for development of new drug
for diabetic retinopathy
-
- No appropriate treatment for diabetic retinopathy (No drugs for oral administration)
- A drug is available for injection for suppressing the formation of new blood vessels.
- Steroid injection or vitrectomy is also used for treatment
Characteristics of
the target drugs
-
Drugs with high efficacy and oral administration are expected.
-
Mechanism of action is expected for inhibition of VEGF, HIF-1α, angiogenesis, and growth promoting factors
-
Inhibits the formation of abnormal acellular capillary in the retina
-
Inhibits the rupture of retinal blood vessel and bleeding
Competitiveness of FB216A1-2
(Efficacy and MoA)
-
Inhibits the expression of abnormal Angiogenesis factors (VEGF, HIF-1α) by FB216A1-2
Cell Culture
Animal Experimnet
Blocking the “important causative agent”
of diabetic retinopathy
-
FB216A1-2 inhibits "abnormal angiogenesis" in the retina
Animal Experimnet
Treatment of the “most core condition”
of diabetic retinopathy
-
Inhibits “vascular bleeding” in the retina of FB216A1-2
Animal Experiment
Inhibits “vascular bleeding” in the retina by FB216A1-2
Competitiveness of FB216A1
Competitiveness of
FB216A1
-
Specialty
MoA
Inhibition of
angiogenesis factors
Broad indications
Nephropathy / retinopathy
Fewer side effects
Natural compounds
-
Marketability
Big Market Size
About $4.8 billion
CAGR
6.6%
(Credence Research; 2018)
-
Monopoly
Secured intellectual
property rights
Domestic patent registration
and international patent
on application
