Kringle Pharma, the Osaka biotech listed on the Tokyo Stock Exchange's Growth market under ticker 4884, has submitted an Investigational New Drug application to the US Food and Drug Administration for oremepermin alfa, its recombinant human HGF protein, seeking to begin a Phase III trial for acute spinal cord injury in the United States. The application is the formal step needed before that trial can start; it does not describe the trial as under way.
The US filing builds on work already done in Japan. Kringle Pharma says it has completed Phase I/II and Phase III trials of oremepermin alfa in Japanese patients with acute spinal cord injury and is now running an additional Phase III study there aimed at a domestic approval application. The drug holds orphan-disease designation for this indication in Japan, the United States and Europe.
The company's chief executive called the filing a step toward global expansion, saying a US IND could help the company pursue partnerships with pharmaceutical companies and broaden access to research funding. Those are stated company aims, not signed agreements: no partner or funding commitment is disclosed.
The company frames the US opportunity with figures it attributes to the National Spinal Cord Injury Statistical Center: about 54 new traumatic spinal cord injury cases per million people each year in the US, more than 18,000 new patients annually, and roughly 310,000 people living with the condition including chronic cases. Fewer than 1% of patients achieve full neurological recovery by the time they leave hospital.
Kringle Pharma is also running a separate Phase III trial of oremepermin alfa for vocal fold scarring in Japan, where patient enrollment is complete and follow-up continues.