View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 4, 2022

Synairgen halts Phase III trial of SNG001 for Covid-19 treatment

The company is awaiting data from the Phase II part of the ACTIV-2 trial in Covid-19 patients in the at-home setting.

Synairgen has temporarily halted the ACTIV-2 Phase III clinical trial of its therapy SNG001 for Covid-19.

The latest move comes after the requirement to modify the trial design due to the emergence of the SARS-CoV-2 virus’ Omicron variant.

Furthermore, the team of the US National Institutes of Health (NIH) ACTIV-2 trial asked the company to provisionally halt activities to ready clinical supplies for ACTIV-2 Phase III until the timeline for the activation of SNG001 in the study is clarified. 

Synairgen is awaiting results from the Phase II part of the US NIH ACTIV-2 trial conducted on Covid-19 patients in the at-home setting. The data is anticipated in the middle of this year.

An inhaled formulation, SNG001 contains the broad-spectrum antiviral protein interferon beta.

According to data from in vitro studies carried out at Viroclinics-DDL in the Netherlands, SNG001 demonstrated to possess potent antiviral activity against Delta and Omicron viral variants at doses that are easily achievable after inhaled administration of interferon-beta.

As reported in February this year, the company is assessing the top-line as well full dataset from the Phase III SPRINTER clinical trial to attain a better understanding of the results. 

Synairgen will report the findings of this assessment soon in compliance with regulatory requirements.

The SPRINTER trial showed a favourable trend in preventing progression to severe disease and morality with a 36% decline in the pre-defined per-protocol population.

Synairgen and its clinical advisors believe that the data warrants additional analysis in a platform trial, which the company is currently studying.

Synairgen reported in February this year that the international Phase III trial of SNG001 in Covid-19 patients admitted to the hospital failed to meet the primary or secondary efficacy endpoints.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

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
SUBSCRIBED

THANK YOU