CORXEL Announces China National Medical Products Administration Approval of the Clinical Trial Application for ORION, the Global Registrational Study of JX10 in Patients with Acute Ischemic Stroke
- ORION is the global registrational clinical trial of JX10, a novel thrombolytic with anti-inflammatory properties, and targets enrollment of 740 patients with acute ischemic stroke in more than 20 countries
SHANGHAI, February 20, 2025 – Corxel Pharmaceuticals (CORXEL), a leading biotech company committed to bringing innovative science and medicines to underserved patients with cardiometabolic diseases around the world, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the PRC (NMPA) has approved the Clinical Trial Application (CTA) for ORION (Optimizing Reperfusion to Improve Outcomes and Neurologic Function), the global registrational study including China cohort, that will investigate the effects of JX10 on functional recovery in acute ischemic stroke (AIS) patients, who present within 4.5 to 24 hours from “last known well”.
“Stroke is a leading cause of death and major contributor to disability with globally more than 12 million new stroke incidents per year, 60-85% of which being ischemic strokes. China accounts for roughly 25% of global stroke cases, with an estimate of yearly 3.4 million new stroke incidents and an estimated 2.3 million stroke-related deaths. This clearly shows the high unmet medical need of this disease and the burden on patients and their families”, said Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL. “JX10 is a potential innovative thrombolytic therapy with which we target to extend the treatment window for acute ischemic stroke to 4.5-24 hours, therefore increasing the number of eligible patients and improving accessibility. We look forward to work with physicians and patients in this clinical trial to evaluate the potential of JX10 as an innovative treatment for acute ischemic stroke and to potentially improve mortality rate and outcomes for this devastating disease.”
Additional information
JX10 is an investigational drug for acute ischemic stroke (AIS). Its proposed mechanism of action includes both thrombolytic and anti-inflammatory activities. By restoring critical blood flow following acute stroke, it may benefit more patients over current standard of care by extending the otherwise short treatment window of 4.5hrs after symptom onset.
In the prior Phase 2 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 initiating a global registrational study to further evaluate the efficacy and safety of JX10 in Acute Ischemic Stroke with late presentations.
CORXEL, is a leading biotech company headquartered in US and China focused on developing innovative cardiometabolic therapies globally. CORXEL was founded in 2019 and has been committed to bringing innovative science and medicines to underserved patients around the world. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to delivering a meaningful and lasting impact on patients.
The portfolio of CORXEL consists of 3 assets with global rights and 2 assets with Greater China rights in late-stage clinical development. The portfolio with global rights covers CX11 for obesity and diabetes, JX10 for acute ischemic stroke (AIS) and JX09 for hypertension, while the portfolio with Greater China rights includes Etripamil and LNZ100.
Contacts:
References:
- GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol 2021; 20; 795–820. https://doi.org/10.1016/S1474-4422(21)00252-0
- Tu, Wen-Jun et al. Estimated Burden of Stroke in China in 2020. Neurology. 2023;6;3. doi:10.1001/jamanetworkopen.2023.1455
- 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
