information: Treatment of the first patient
Announcement: treatment of the first patient
Company: Arrowhead Pharmaceuticals (USA - CA)
- RNAi. ARO-HBV silences all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act.
Disease: chronic hepatitis B virus (HBV) infection
area: Infectious diseases
Country: New Zealand
- AROHBV1001 is a Phase 1/2 study evaluating the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, and evaluating the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.
- The SAD portion is designed to include up to 5 cohorts of 6 subjects per cohort. Each SAD subject will receive a single-dose administration of either placebo or ARO-HBV at up to 5 dose levels (35, 100, 200, 300, 400 mg). The MAD portion is designed to include up to 8 cohorts of 4 HBV patients per cohort. Each MAD patient will receive 3 doses of ARO-HBV at up to 4 dose levels (100, 200, 300, 400 mg). (NCT03365947)
- • On May 14, 2018, Arrowhead Pharmaceuticals announced that it has dosed the first 3 hepatitis B virus (HBV) patients in the multiple-ascending dose portion of its ongoing Phase 1/2 study of ARO-HBV, the company’s third generation subcutaneously administered RNA interference (RNAi) therapeutic being developed as a potentially curative therapy for patients with chronic HBV infection.
- Arrowhead has also dosed a total of 20 healthy volunteers (13 with ARO-HBV and 7 with placebo) since the study began on March 27. The company intends to submit a late-breaking abstract to present initial clinical data on ARO-HBV, if accepted, at the Liver Meeting® 2018, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), being held in November.
- • On December 22, 2017, Arrowhead Pharmaceuticals announced that it filed a regulatory submission to begin a Phase 1/2 study of ARO-HBV, which is being developed as a potentially curative therapy for patients with chronic hepatitis B virus (HBV) infection. Pending approval, Arrowhead intends to proceed with AROHBV1001, a Phase 1/2 single-dose escalation study to evaluate the safety, tolerability, and pharmacokinetic effects of ARO-HBV in healthy adult volunteers, as well as a multiple-dose escalation study to evaluate the safety, tolerability, and pharmacodynamic effects in HBV patients. The application for approval of the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for review by the Standing Committee on Therapeutic Trials (SCOTT), as well as the local Ethics Committee