HT-101 / Suzhou HepaThera Biotech - LARVOL DELTA

High rate and sustained HBsAg loss achieved with HT-101 plus HT-102 combination therapy in HBeAg-negative, nucleos(t)ide analogue-suppressed patients: ongoing off-treatment results from a multicenter Ib/IIa study (EASL 2026) - P1/2 | "Combination therapy with HT-101 and HT-102 achieved very high rate of HBsAg loss which was sustained for 8 weeks post-treatment. HT-101 monotherapy demonstrated durable HBsAg loss for up to 24 weeks post-treatment. These results support the continued development of HT-101 and HT-102 as a promising strategy for achieving functional cure in patients with chronic HBV infection."

Clinical • Combination therapy • Late-breaking abstract • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Combination therapy with HT-101 and HT-102 achieves rapid and progressive HBsAg loss in HBeAg-negative, nucleos(t)ide analogues-suppressed patients: 24-week results from an ongoing multicentre, open-label phase Ib/IIa study (APASL 2026) - No abstract available

Clinical • Combination therapy • P1/2 data

A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Suzhou HepaThera Biotech Co., Ltd.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1/2 | N=86 | Active, not recruiting | Sponsor: Suzhou HepaThera Biotech Co., Ltd.

New P1/2 trial • Hepatitis B • Infectious Disease • Inflammation

A Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT-101, an RNAi Therapeutic Targeting HBV Infection. (PubMed, Clin Pharmacol Drug Dev) - "Moreover, a single dose of HT-101 at 25-800 mg was safe and well tolerated in healthy Chinese volunteers. These data can support further clinical development of HT-101 for hepatitis B virus infection treatment."

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

Robust and sustained hepatitis B surface antigen reduction after HT-101 dosed twice in chronic hepatitis B patients: results from a phase I study including extension follow-up data (APASL 2025) - P1 | "Two monthly SC doses of HT-101 were general safe and well tolerated with a favourable PK profile in HBV-infected patients. Dose-dependent significant reductions from baseline in HBsAg levels were observed through up to 44weeks post last dose, including 1subject achieved HBsAg seroclearance at w48. These data support the continued development of HT-101 for treatment of chronic HBV infection."

Clinical • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Inhibition of Hepatitis B Virus Replication by a Novel GalNAc-siRNA In Vivo and In Vitro. (PubMed, ACS Omega) - "Compared with the vehicle group from days 7 to 70 postdosing, especially in the high-dose group (9 mpk), plasma levels of HBsAg, HBeAg, and HBV DNA were significantly reduced with mean reduction values ranging from 1.72 to 3.38 log10 copy/mL due to long-lasting suppression of HBsAg below the lower limit of quantitation (LLOQ), ultimately leading to induction of anti-HBs. In summary, the preclinical data demonstrate that HT-101 represents a significant breakthrough in reducing antigens and provides a promising strategy for functional cure of HBV."

Journal • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

This is a Phase 1 Study in Which Healthy Volunteers and Participants with Chronic HBV Infection Will Receive HT-101 or Placebo and Will Be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (clinicaltrials.gov) - P1 | N=82 | Completed | Sponsor: Suzhou HepaThera Biotech Co., Ltd.

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

HT0101 All are invited to the Nursing Networking Zone! (AIDS 2024) - "Presentations and guided discussions will centre on the intersections of HIV and co-morbidities with racism, ageing, gender equality, sexual identity, poverty and other social justice factors and the impact on health outcomes on key populations and other vulnerable communities. The zone will have a nursing focus – but all attendees are invited to stop by and show your support for the nursing workforce!."

Human Immunodeficiency Virus • Infectious Disease

Safety, tolerability, and hepatitis B surface antigen reduction of HT-101 in chronic hepatitis B patients: preliminary results from a phaseⅠb study (EASL-ILC 2024) - "Two monthly doses of HT-101 administered SC were well safe and tolerated in Chinese patients with chronic HBV infection. Dose-dependent significant reductions from baseline in serum HBsAg levels were achieved through up to 16 weeks post last dose. Higher doses of HT-101 will be evaluated in subsequent cohort."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A double-blind, placebo-controlled, single-ascending dose phase Ⅰa study to evaluate the safety, tolerability, and pharmacokinetics of HT-101, an investigational small interfering ribonucleic acid targeting hepatitis B virus in Chinese healthy subjects (EASL-ILC 2024) - "A single SC dose of HT-101 at 25~800 mg was safe and well tolerated in Chinese healthy subjects. These data support further clinical development of HT-101 for HBV infection treatment."

Clinical • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation