Source: Clinical Trials Arena
SyneuRx International has concluded subject enrolment in the Phase II clinical trial of the new Covid-19 oral antiviral candidate, SNB01 (Pentarlandir).
Pentarlandir acts on the main protease, or 3CL-protease and hinders TMPRSS2 for entry of the virus.
The double-blind, placebo-controlled trial will assess the safety, efficacy, pharmacokinetics (PK), viral shedding and clinical effects of Pentarlandir UPPTA in individuals with early Covid-19.
A total of 89 subjects who are unvaccinated or have early-stage breakthrough Covid-19 were enrolled in the trial.
These participants were randomised to receive either high-dose or low-dose of the antiviral or placebo.
SyneuRx founder and CEO Emil Tsai said: “Covid-19 continues to plague many parts of the world, including individuals who are immunocompromised, unvaccinated or not up to date on vaccines, or who experience breakthrough infection even when vaccinations are up to date.
“Our goal from the start has been to introduce a safe, effective and accessible therapeutic with multiple use cases, including the ability to work against most Covid-19 variants and treat certain influenza strains in order to keep high-risk patients from hospitalisation due to the potential ‘twindemic’ caused by Covid-19 and/or influenza.”
Pentarlandir was found to show initial efficacy and an encouraging safety profile against various variants of the SARS-CoV-2 virus, including Omicron and Delta, as well as several influenza viruses, in preclinical studies.
This trial will enable selection of an optimal dose for the Phase III trial study, anticipated to commence soon.
It will assess the broad-spectrum antiviral activity of Pentarlandir in hindering SARS-CoV-2 and influenza viruses, including rigorous safety evaluations.
In November last year, the company reported that the antiviral entered the final segment of the Phase II trial and neared the Phase III trial.