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Profile
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Delegates :
Kiichi Adachi |
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Incorporated :
December 21 , 2001 |
Paid in Capital :
432 Million yen |
Employees :
11 人 |
Address :
Saito Bio Incubator 207, 7-7-15 Asagi, Saito Osaka Prefecture, Ibaraki City, OSAKA
〒567-0085
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TEL/FAX :
+81-72-641-8739 / |
URL：
https://www.kringle-pharma.com/en/ |
Attachment :
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Mission/Background :
Kringle Pharma is a late clinical-stage biopharmaceutical company focused on research and development of regenerative medicines. We are currently conducting clinical trials of recombinant human HGF for the treatment of acute spinal cord injury, vocal fold scar, ALS and acute kidney injury. |
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Technology & Business
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Hepatocyte growth factor, HGF, possesses a wide variety of physiological properties, not only mitogenic, but also motogenic, morphogenic, angiogenic, anti-apoptotic (cell death) and anti-fibrotic functions. HGF turns out to be an intrinsic organotrophic factor in the regeneration and repair of various tissues and organs including the liver, kidneys, skin, blood vessels and the nervous system. Preclinical studies with animal disease models indicated therapeutic efficacy of HGF for many incurable diseases.
Kringle Pharma is the only company in the world who have capability to mass-produce GMP-compliant, pharmaceutical-grade HGF (hepatocyte growth factor) for clinical use and have multiple clinical-stage pipelines. We aim to provide novel HGF therapies to the world for patients suffering from intractable diseases for which there is no truly effective treatment.
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Products & Service
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Products & Service Name
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Stage
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Outline
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Milestone
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Acute spinal cord injury
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Phase3
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Phase 1/2, placebo-controlled study completed in Japan. Orphan drug designation Phase 3, nonrandomized, confirmatory study compl
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Discussion ongoing with PMDA to apply for manufacturing and marketing approval in Japan.
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Vocal fold scar
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Phase3
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Phase 1/2, dose escalating, investigator-initiated study completed in Japan. Phase 3, double-blind, placebo-controlled study ong
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Patient enrollment ongoing at 6 clinical sites in Japan
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ALS
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Phase2
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Phase 2, investigator-initiated study completed in Japan. No statistically significant difference in endpoints.
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Collaborative research started with Tohoku University for additional biomarker analysis of Phase 2
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Acute kidney injur
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Phase1
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Phase 1a and 1b, single and repeated dosing studies completed in the U.S. Searching for a partner
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Seeking pharmaceutical partners to initiate Phase 2
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Highlights
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May 2024; “Oremepermin Alfa (Genetical Recombination)” approved as Japanese Accepted Names for Pharmaceuticals of HGF.
May 2024; Additional clinical site (Sanno Medical Center) opened for Phase 3 study of HGF for vocal cord scar.
April 2024; Collaborative research started with Tohoku University for additional biomarker analysis of Phase 2 study.
February 2024; Topline Data from Phase 3 Study of HGF in Acute Spinal Cord Injury.
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Alliance strategy
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In the existing pipeline, we are seeking development and commercialization partners for acute spinal cord injury (overseas except Japan), vocal cord scarring (worldwide), ALS (worldwide), and acute kidney injury (worldwide).
In addition, we are seeking pharmaceutical partners for new target indications for HGF.
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