Business

Areas of Disease and Pipeline

Areas of disease expected as possible indications for “Regeneration-Inducing Medicine

Because “Regeneration-Inducing Medicine” does not act directly on the affected part of the disease, but instead acts on stem cells present in areas such as the bone marrow or blood, it may overcome many issues associated with conventional regenerative medicine/cell therapy, and can target treatment for diseases that have been difficult to treat with conventional therapies. If our “Regeneration-Inducing Medicine” is put into practice, it is expected to develop a broad range of clinical applications.

Overview of development pipeline

Our research and development pipeline is show below, together with the current state of progress. The pipeline is divided into the following five projects (PJ1 to PJ5). The main target markets for each pipeline are Japan, the US and Europe.

Project
code
Development candidate Indication Investigator Development stage Out-license
partner
Research Pre-
clinical
Phase 1
study
Phase 2
study
Phase 3
study
PJ1 -01 Redasemtide
(HMGB1 cell mobilization domain peptides)
Epidermolysis
bullosa
Shionogi & Co., Ltd.
Additional Phase 2 study on going  
 
 
Shionogi & Co., Ltd.
(S-005151)
-02 Cerebral infarction
(acute phase)
Shionogi & Co., Ltd.
Global Phase 2
study on going
-03 Cardiomyopathy(ischemic cardiomyopathy/dilated cardiomyopathy) Osaka University
 
-04 Osteoarthritis of the knee Hirosaki University
 
-05 Chronic liver disease Niigata University
 
PJ2 -01 TRIM3(Novel Regeneration-Inducing Peptide
for Systemic administration)
Multiple tissue
damage diseases
In-house
(partnership is planned)
     
-02 TRIM4(Novel Regeneration-Inducing Peptide
for Systemic administration)
Multiple tissue
damage diseases
In-house
(partnership is planned)
     
PJ3 Novel Regeneration-Inducing Peptide
for Local administration
Multiple tissue
damage diseases
In-house
(partnership is planned)
     
PJ4 Autologous cell collection device for treatment Multiple tissue
damage diseases
In-house
(partnership is planned)
ND
PJ5 Stem cell gene therapy Epidermolysis
bullosa
In-house
(partnership is planned)
Phase 1,2 study non

In the case of PJ1 -01, the number of target patients with epidermolysis bullosa dystrophica, is around 400 in Japan, and therefore it is not feasible to plan a large-scale phase 3 study. In addition, epidermolysis bullosa dystrophica is a rare intractable disease, and there is currently no effective therapy. Accordingly, we expect to apply for a marketing approval for the drug based on the results of the additional phase 2 study.

In the case of PJ4, we are currently coordinating development plans, and do not currently expect to conduct studies after phase I, but as no final decision has been made, this is marked ND.