Spring Bank Pharmaceuticals announced that the company has stopped dosing and enrolling patients in its Phase 2b CATALYST trials, which are evaluating inarigivir soproxil 400mg for the treatment of chronic hepatitis B virus (HBV). In addition, the company has stopped dosing and enrollment in all other studies of inarigivir in subjects with chronic HBV.
The decision to stop the dosing of inarigivir 400mg in the Phase 2b CATALYST trials was due to clinical findings observed in the CATALYST 2 trial of virally-suppressed chronic HBV patients. Laboratory findings revealed that three subjects participating in this trial showed evidence of hepatocellular dysfunction and an elevation of alanine transaminase (ALT) potentially consistent with liver injury rather than immune flares.
The company is investigating and analyzing the data to gain a better understanding of the findings and potential causes thereof and is further evaluating safety data across the almost 100 patients who have received inarigivir at this dose.
Inarigivir is an orally available candidate being developed for the treatment of chronic hepatitis B virus infection. It was designed to selectively activate within cells infected with HBV. Inarigivir binds the cellular proteins retinoic acid-inducible gene 1 (RIG-I) to inhibit viral replication and to cause the induction of intracellular interferon signaling pathways for antiviral defense.
About Hepatitis B
Hepatitis B is a liver infection caused by the hepatitis B virus (HBV). The hepatitis B virus is transmitted when blood, semen, or another body fluid from a person infected with the virus enters the body of someone who is not infected. This can happen through sexual contact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth. For some people, hepatitis B is an acute, or short-term, illness but for others, it can become a long-term, chronic infection. Risk for chronic infection is related to age at infection: approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic hepatitis B can lead to serious health issues, like cirrhosis or liver cancer.