Arrowhead Collaboration presents Phase IIb data from Hepatitis B study
pharmafile | November 16, 2021 | News story | Manufacturing and Production |
Arrowhead Pharmaceuticals Inc collaborator, Janssen Pharmaceuticals Inc, have presented clinical data from REEF-1, a Phase IIb study of different combination regimens. This included JNJ-73763989, formerly called ARO-HBV, and a nucleostide analog (NA) for the treatment of chronic hepatitis B virus infection (CHB).
JNJ-3989 is an investigational small interfering RNA (siRNA), which targets all hepatitis B virus (HBV) RNAs. JNJ-6379 is an investigational capsis assembly modulator (CAM-N) that inhibits viral replication by inducing the formation of non-infectious viral particles which are devoid of HBV DNA and RNA. In October 2018, Arrowhead entered into a license and collaboration agreement with Janssen to develop and commercialise JNJ-3989.
REEF-1 is a Phase IIb, multicenter, double-blind, active-controlled, randomised study to assess the efficacy and safety over 48 weeks of monthly subcutaneous injections of JNJ-3989 (3 dose levels of 40, 100, and 200mg), and/or 250mg daily oral JNJ-6379 in combination with daily oral NA in currently not treated or virally suppressed patients with HBeAG positive or negative CHB.
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases, by silencing the genes that cause them. Their broad portfolio of therapiest trigger the RNA interference mechanism to induce rapid and durable knockdown of target genes. RNA intereference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, affecting the production of a specific protein.
The greatest reduction in HBsAg was observed in the JNJ-3989 200mg with NA cohort, and a dose dependent response was observed in other cohorts. All regimens within this long-term study were generally well tolerated and have a favourable safety profile.
Lina Adams
