View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
June 29, 2022

Ascletis doses first participant in Phase II HIV-1 treatment trial

The trial will analyse the safety and efficacy of ASC22 along with ART versus placebo in HIV-1 patients.

Ascletis Pharma has dosed the first subject in the Phase II clinical trial of ASC22 (Envafolimab) plus anti-retroviral therapy (ART) for immune restoration/ functional cure of human immunodeficiency virus 1 (HIV-1) infection in China.

Given subcutaneously, ASC22 is a single domain antibody against programmed death-ligand 1 (PD-L1). 

It could potentially restore virus-specific immune responses in people with chronic viral infection. 

The randomised, placebo-controlled, single-blind, multicentre trial will analyse the safety and efficacy of ASC22 to treat HIV-1 infection versus placebo, along with ART during a 12-week treatment and 12-week follow-up period.

The company plans to conclude the trial earlier next year and will enrol nearly 30 subjects.

Participants in the ASC22 group will be given subcutaneous doses of 1mg/kg or 2.5mg/kg plus standard ART including integrase inhibitors (INSTIs) once every four weeks (Q4W) for 12 weeks. 

Subjects in the placebo arm will receive 0.9% saline plus ART Q4W for 12 weeks. 

The primary outcome measures of the trial are variation in CD4/CD8 ratio from baseline recorded at weeks 4, 8 and 12.

Ascletis Pharma founder, chairman and CEO Dr Jinzi Wu said: “By blocking PD-1/PD-L1 pathway, ASC22 is expected to potentially restore HIV-1 specific immunity and clear the latent HIV reservoir. 

“We will accelerate the clinical study of ASC22 and share more milestones in the near future.”

Apart from the immune restoration/functional cure indication for HIV-1, the company developed another indication of ASC22 as a functional cure for chronic hepatitis B.

In April this year, Ascletis reported that its oral small molecule drug candidate, ASC11, demonstrated the potential to treat Covid-19.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena