Research & Development Pipeline

Product pipeline of currently disclosed themes

 

Development code

Product name, etc.

Lead indication Target market Stage

In-house

In-license

SI-6603
Condoliase
Lumbar disk herniation

 

Japan

 

 

NDA Filed

In-house

 

U.S.

 

 

Phase III

 

SI-613

Diclofenac Etalhyaluronate

Sodium

 

Osteoarthritis Japan

 

Phase III

 

 

In-house

 

Knee

osteoarthritis

U.S.

 

Phase II

 

SI-613-ETP

Diclofenac Etalhyaluronate

Sodium

Enthesopathy Japan

Late-Stage

Phase II

SI-614
Modified Hyaluronate

Dry eye U.S.

 

Phase II / III

 

In-house

(As of November 7, 2017)

Outline of development theme

SI-6603 (treatment for lumbar disc herniation - developed in Japan and the U.S.)

SI-6603, an enzyme named condoliase, is thought to be effective in reducing pressure on the nerve that is the cause of lumbar disc herniation pain. Currently, there is no fundamental pharmacological therapy for lumbar disc herniation. A single dose of SI-6603 is expected to be as effective as surgery in alleviating symptoms, so, patients could expect improved quality of life (QOL).

SI-613 (treatment of osteoarthritis - developed in Japan and the U.S.)

SI-613-ETP (treatment of enthesopathy - developed in Japan)

SI-613 is a formulation in which hyaluronic acid and a diclofenac (anti-inflammatory drug)

are chemically bound using Seikagaku’s own proprietary technology. SI-613 was designed to provide pain relief and anti-inflammatory effect by sustained release of diclofenac, and the joint function improving effect by hyaluronic acid. It is expected to provide prompt and sustained relief of the severe pain and inflammation associated with osteoarthritis and enthesopathy. Since SI-613 is administered directly into the joint cavity or near the tendon or ligament enthesis as an injectable treatment, the transfer of the NSAID into the systemic blood is extremely low, and it is expected to mitigate the risk of side effects reported in oral or transdermal administration of NSAID.

SI-614 (treatment of dry eye - developed in the U.S.)

SI-614 is a modified hyaluronate that is produced using the Company’s proprietary technology. Ocular instillation of SI-614 in patients with dry eye is expected to protect
the ocular surface and promote corneal wound healing.