CORXEL Announces First Patient Enrolled in ORION, the Registrational Clinical Trial of JX10 in Patients with Acute Ischemic Stroke
- Initiated multi-regional clinical trial of JX10, a novel thrombolytic with anti-inflammatory properties
- ORION targets enrollment of approximately 740 patients with acute ischemic stroke in more than 20 countries
NEW JERSEY/SHANGHAI, May 16, 2025 – Corxel Pharmaceuticals Limited (“CORXEL”), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world, announced the enrollment of the first patient in the registrational clinical trial for JX10 at Beijing Tiantan Hospital, Capital Medical University. The ORION (Optimizing Reperfusion to Improve Outcomes and Neurologic Function) trial will investigate the effects of JX10 on neurologic outcomes in acute ischemic stroke (“AIS”) patients, who present within 4.5 to 24 hours from “last known well” (“LKW”).
“As the largest clinical trial in CORXEL’s 5-year history, ORION represents a significant milestone for us and for the development of JX10”, said Edmond Chen, MD, CMO of CORXEL. “ORION builds on the encouraging findings from the Japan Phase 2a study, which demonstrated that treatment with JX10 up to 12 hours from symptom onset resulted in improved neurologic outcomes at 90 days, compared to placebo. We are excited about this first step to potentially improving the care of stroke patients worldwide.”
Additional information
ORION (Optimizing Reperfusion to Improve Outcomes and Neurologic Function) is a multicenter, operationally seamless, double-blind, placebo-controlled, randomized, parallel-group Phase 2/3 trial, evaluating the efficacy and safety of intravenous (“IV”) JX10 in AIS participants between 4.5 and 24 hours after LKW. The trial is spanning over 20 countries across more than 150 sites globally. CORXEL expects to enroll approximately 740 participants, with Part 1 including 240 participants for dose-ranging and Part 2 including 500 participants to evaluate the effects of the selected dose. The primary efficacy outcome measure is the modified Rankin Scale (“mRS”) at Day 90, assessing functional independence.
JX10 is an investigational drug for AIS. Its proposed mechanism of action includes both thrombolytic and anti-inflammatory activities. By restoring critical blood flow following acute stroke, it has the potential to benefit more patients over current standard of care by extending the otherwise short treatment window of 4.5 hours after symptom onset.
In the prior Phase 2a clinical trial conducted in Japan, patients treated with JX10 had significantly improved clinical outcomes (proportion of patients with no or minimal neurological deficits) at 90 days, compared to placebo. This was further supported by safety and angiographic findings. CORXEL is currently conducting the ORION trial, a global registrational trial to further evaluate the efficacy and safety of JX10 in AIS patients, who present within 4.5 to 24 hours from “LKW”.
CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL's diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral GLP-1 receptor agonist (GLP-1 RA) for obese and overweight patients, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke (AIS) and JX09, a highly selective aldosterone synthase inhibitor (ASI) for hypertension.
For further information about CORXEL, please visit www.corxelbio.com
Contacts:
References:
- Niizuma, Kuniyasu et al. Anti-Inflammatory Thrombolytic JX10 (TMS-007) in Late Presentation of Acute Ischemic Stroke. Stroke. 2024;55;12. https://doi.org/10.1161/STROKEAHA.124.048464
