Kringle Pharma, Inc.

Looking for EU partners for a licensing or co-development agreement

KEY ACTIVITIES Drug development, clinical stage
SECTOR: Biotech / Pharmaceutical
KEY WORDS: Recombinant human hepatocyte growth factor, Spinal cord injury, ALS, Acute kidney injury, Vocal fold scar
TYPE OF ACTIVITIES R&D collaboration

Company Activity Description:

Kringle Pharma is a clinical-stage biopharmaceutical company aiming to develop novel biologics based on hepatocyte growth factor, HGF. Currently, Kringle is pursuing clinical development of recombinant human HGF, KP-100, for incurable diseases, such as acute spinal cord injury, ALS, acute kidney injury and vocal fold scar.

Kringle is looking for pharmaceutical partners to out-license or co-develop these clinical programs.

 

Type of Partnership Sought:

1.License agreement
2.Co-development agreement

 

Additional information:

HGF was originally found as a mitogen for mature hepatocytes, and subsequent studies elucidated that HGF acts on various epithelial and vascular cells. HGF facilitates regeneration and protection of tissues damaged by injury and disease through its mitogenic, motogenic, and morphogenic properties as well as anti-apoptotic and angiogenic activities. It is anticipated that recombinant human HGF, KP-100, will be an effective and novel biological drug in the treatment of many incurable diseases. Kringle Pharma has established GMP manufacturing of KP-100 and initiated clinical development as follows.

 

Products & Service

Stage

Outline

Milestone

1) KP-100IT for acute spinal cord injury

Phase I/II ongoing in Japan

A placebo controlled, double-blind trial to confirm POCClinicalTrials.gov Identifier: NCT02193334

Completion of subject enrolment and unbinding. Clinical data available in the 1Q 2019.

2) KP-100IT for ALS

Investigator-initiated Phase II ongoing in Japan

A placebo controlled, double-blind trial to confirm POC

Completion of subject enrolment expected in 2020

3) KP-100 for acute kidney injury

Phase Ia and Ib completed in the U.S.

Single and multiple dose-escalation studies to evaluate the safety and PK

Safety and PK profile were confirmed for single and multiple dosing

4) KP-100LI for vocal fold scar

Investigator-initiated Phase I/II completed in Japan

An open-label, dose-escalation study to evaluate the safety and efficacy

Clinical results were published in Journal of Tissue Engineering and Regenerative Medicine (25 DEC 2017, DOI: 10.1002/term.2603).