RG6217 / Roche - LARVOL DELTA

Safety, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide RO7239958 in healthy volunteers and adults with chronic hepatitis B infection. (PubMed, Antimicrob Agents Chemother) - P1 | "At 0.4 mg/kg, the maximum reduction from baseline in serum hepatitis B surface antigen was observed on Day 43 (mean decline 0.2 log10 IU/mL; range 0.0-0.5 log10 IU/mL). While RO7239958 showed a potentially narrow therapeutic window, PAPD5 and PAPD7 remain potential therapeutic targets in HBV curative strategies.CLINICAL TRIALSThis study was registered at NCT03762681."

Journal • PK/PD data • Hepatitis B • Infectious Disease • Inflammation

A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1; N=55; Terminated; Sponsor: Hoffmann-La Roche; Trial completion date: Mar 2021 ➔ Apr 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Mar 2021 ➔ Apr 2020; The study was terminated due to program discontinuation.

Clinical • Trial completion date • Trial primary completion date • Trial termination • Hepatitis B • Infectious Disease

"$RHHBY has discontinued RG6217, a hep B antiviral in ph1 (discontinuations of balovaptan and idasanutlin had already been announced in Q1)." (@JacobPlieth)

A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1; N=75; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hepatitis B • Infectious Disease

A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Nov 2021 ➔ Mar 2021; Trial primary completion date: Nov 2021 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date