Biopharmaceutical company PTC Therapeutics has initiated enrolment in the second stage of a Phase II/III FITE19 clinical trial of its investigational drug, PTC299, in Covid-19 patients.
An oral small molecule, PTC299 inhibits the cellular enzyme dihydroorotate dehydrogenase.
With its dual mechanism of action, it can potentially hinder viral replication and attenuate the uncontrolled inflammatory response that follows infection.
Currently, the second stage of the trial is enrolling in multiple centres outside of the US.
The randomised, double-blind, placebo-controlled, multi-centre trial will assess the efficacy and safety of PTC299 in hospitalised Covid-19 patients.
PTC noted that the study is conducted in two stages. The first stage had a smaller cohort of 40 participants followed by an interim safety analysis before enrolling the larger cohort of around 340 participants in the second stage.
Analysing the clinical efficacy of PTC299 versus placebo assessed by time to respiratory improvement in adults hospitalised with Covid-19 will be the study’s primary endpoint.
PTC Therapeutics CEO Stuart Peltz said: “Completion of the first stage of the FITE19 trial is an important milestone that triggers the final stage of the trial to begin.
“PTC299 has a unique mechanism of action that has the potential to be an effective Covid-19 treatment for both at-home and hospitalised patients and should be effective against the wildtype virus as well as viral variants.”
Earlier this month, PTC Therapeutics announced plans to hold talks with the US Food and Drug Administration (FDA) on approval after the latest Phase II Study 045 of its drug, Translarna (ataluren), failed to significantly improve dystrophin expression in patients with nonsense mutation Duchenne muscular dystrophy.
In a separate development, Biophytis is set to start patient recruitment in France and Belgium for Part 2 of its COVA Study of Sarconeos (BIO101) as a potential treatment for acute respiratory failure linked to Covid-19.
On obtaining the Data Monitoring Committee (DMC) recommendation to start the recruitment for Part 2, approval was obtained from regulatory agencies in Brazil and the US for most clinical centres in these countries.