Hepion Pharmaceuticals Inc. (NASDAQ:HEPA) has announced results from its translational research study of CRV431, it’s lead drug candidate. CRV431 demonstrated a decrease in the formation of “procoagulant platelets,” which are a new class of human blood platelets. Usually, high procoagulant platelet levels are associated with short-lived ischemic attack and stroke.
CRV431 shows potential in liver disease
Advanced liver disease patients often experience coagulopathy disorders, dyslipidemia, and diabetes. Sometimes that can develop ischemic and hemorrhagic diseases. For instance, NASH and non-alcoholic fatty liver disease patients are at risk of ischemic stroke. Interestingly NAFLD patients can sometimes suffer a severe stroke, which requires aggressive management of liver disease. According to nonclinical studies, cyclophilins, which is CRV431 inhibited enzymes, can result in platelet activities. This promoted the company to conduct the current in vitro study examining CRV431’s effect on platelets.
The study showed that CRV431 treatment at pharmacologically accepted doses reduced phosphatidylserine membrane exposure by up to 49%. Most important, CRV431 didn’t have any significant effect on platelet aggregation. Hepion’s SVP Clinical Pharmacology and Analytics, Patrick Mayo, said that NAFLD and NASH are cardiovascular disease risk factors. Also, ischemic stroke risks and prognosis are related to liver diseases such as NASH. He said that the study results were intriguing because blocking procoagulant formation could offer a new anti-thrombotic strategy, especially in stroke prevention, where elevated procoagulant platelets are observed. So far, CRV431 has shown that it can reduce hepatocellular carcinoma, fibrosis, inflammation, and now procoagulant platelets.
Hepion receives approval for the dose-escalation study
The company recently received approval from an independent Data Safety Monitoring Board (DSMB) to continue the Phase 2a AMBITION clinical study to the next dose level. DSMB evaluated tolerability and safety of the 75 mg CRV431 dose level in NASH patients. The company will now enroll NASH patients in the study for the 225 mg dose cohort.
The AMBITION study is the first CRV431 trail in NAHS patients having moderate-to-severe fibrosis. Patients received CRV431 orally once per day for 28 weeks. The study’s primary objective was assessing CRV431’s safety, tolerability, and delineating pharmacokinetics.