Kringle Pharma (TYO:4884) has begun an additional phase three clinical study in Japan testing oremepermin alfa as a treatment for patients with acute spinal cord injury (SCI), according to a Friday filing.
The biopharmaceutical company plans to enroll 10 patients diagnosed with AIS grade A cervical SCI across three national SCI hospitals.
The company's primary endpoint is the proportion of patients with improved neurological status to AIS grade C or better after six months.
The additional phase three study includes refined eligibility criteria that enrich responders, with exclusion of patients with severe structural spinal cord damage on magnetic resonance imaging.