Clinical-stage biotherapeutics company PureTech Health has initiated the global, Phase II trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related Sequelae.
A condition where Covid-19 survivors are at risk of persistent complications is known as Long COVID or Long Haul COVID.
A deuterated analogue of pirfenidone, LYT-100 is an oral small molecule wholly owned by PureTech.
The product candidate is being advanced for potentially treating conditions involving inflammation and fibrosis and lymphatic flow disorders.
The Phase II trial began after the completion of a Phase I multiple ascending dose and food effect study of LYT-100 in healthy volunteers.
Data from the Phase I trial showed favourable proof-of-concept for the product candidate’s tolerability and pharmacokinetic profile.
The latest global, randomised, double-blind, placebo-controlled Phase II trial will analyse the efficacy, safety and tolerability of LYT-100 in adults with post-acute Covid-19 respiratory complications.
The trial’s primary endpoint will be the six-minute walk test distance and secondary endpoints include pharmacokinetics, inflammatory biomarkers, imaging and patient-reported outcomes.
PureTech Long COVID Phase II trial principal investigator Toby Maher said: “Covid-19 is a global public health crisis with severe and long-lasting effects.
“Patients around the world have reported persistent suffering, including serious respiratory complications that can last for months after the acute infection resolves, and, even with vaccines, there is great a need for treatment options for Long COVID.
“The anti-fibrotic and anti-inflammatory properties of LYT-100 hold potential for treating a range of respiratory conditions, including the long-lasting health burden associated with post-acute Covid-19.”
Results from the study initiated in the US and Europe are expected in the second half of next year.
In May, PureTech announced plans to conduct a trial to evaluate LYT-100 to treat Long COVID.