kringle-pharmaCo., Ltd.

DEVELOPMENT

Research and Development

Research and Development

Drug candidate

Our company is pursuing the research and development of recombinant human hepatocyte growth factor (HGF) protein, and this protein has been the subject of clinical studies in incurable diseases. HGF was initially discovered as a growth factor for hepatocytes. By binding to the cell surface receptor, HGF transmits signals to the cell nucleus (genes) to initiate cell growth. Because HGF works intrinsically in the human body, it can be used as a recombinant protein to formulate a pharmaceutical product with a high degree of safety and efficacy.

Subsequent studies have revealed that HGF also has multiple biological activities other than promoting cell growth, as well as effects on the cells of organs such as the kidneys, lungs, and skin in addition to liver. Several studies have reported that HGF can be used as a drug candidate for multiple intractable diseases on clarification of its action to inhibit fibrosis or stiffening (referred to as an antifibrotic effect), which involves impaired cell function owing to the accumulation of fibrotic components, as well as its biological activities on neural cells such as neurons and glial cells.

Drug developmental pipeline

our drug candidates in our pipeline for the treatment of acute spinal cord injury, amyotrophic lateral sclerosis (ALS), vocal fold scarring, and acute kidney injury have progressed to clinical trials. Another drug candidate in the pipeline showed efficacy in animal disease models and is being prepared for testing in a clinical trial, while several other candidates are still in the basic research stage. Currently, we are focusing on our most advanced pipeline drug for treating acute spinal cord injury and concentrating our resources to obtain a regulatory approval on our own.

Indication Development stage Clinical study NDA/Approval Partner
Phase I Phase II Phase III
Acute spinal cord injury -Phase I/II (double-blind, placebo-controlled study) completed with proof-of-concept clinical data -Phase III (nonrandomized, confirmatory study) ongoing in Japan Completed Completed Ongoing Maruishi Pharmaceutical Co., Ltd.
and Toho Holdings CO., LTD. in the Japanese territory
ALS -Phase I (open-labelled, dose escalating study) completed -Phase II (double-blind, placebo-controlled, investigator initiated study) ongoing in Japan Completed Ongoing
Vocal fold scar -Phase I/II (open-labelled, dose escalating, investigator initiated study) completed in Japan -Preparing for the next phase study Completed Completed Planning
Acute kidney injury -Phase Ia and Ib (single and repeated dosing study) completed in the U.S. -Searching for a partner Completed Searching for a partner

Diseases with potential clinical application of recombinant human HGF protein

Potential for expanded indications of regenerative medicine HGF