PureTech advances experimental COVID-19 drug into global trials

UK clinical-stage biotherapeutics group PureTech has unveiled plans to advance its wholly-owned clinical-stage product candidate LYT-100 (deupirfenidone) as a potential treatment for serious respiratory complications, including inflammation and fibrosis, that persist following the resolution of SARS-CoV-2 (COVID-19) infection.

The firm says LYT-100 employs a multimodal mechanism of action to potentially reduce, delay or prevent the lung dysfunction documented in COVID-19 patients, including those who have recovered from the infection.

The global, randomised, placebo-controlled trial is expected to begin in the third quarter and will evaluate LYT-100 in non-critical COVID-19 patients with respiratory complications, with top-line data expected mid 2021.

“Hundreds of clinical trials are underway to combat COVID-19, but the vast majority are focused on vaccines or the acute treatment of severe patients,” said Dennis Ausiello, former chief of medicine at Massachusetts General Hospital and a member of the PureTech R&D Committee.

“As we learn more about the full impact of COVID-19 on the body, we’re seeing post-recovery, longer-term pulmonary dysfunction similar to that observed following infection with other coronaviruses, including SARS and MERS.

“In fact, emerging data suggest that a high proportion of COVID-19 patients are at risk of impaired lung function and fibrosis after recovery, as well as during acute infection. With more than five million documented infections to date worldwide, there is a clear and urgent need for therapeutics to address the longer-term sequalae of COVID-19.”

LYT-100 is an oral anti-fibrotic and anti-inflammatory small molecule. It is a deuterated analogue of pirfenidone, a drug approved for the treatment of idiopathic pulmonary fibrosis (IPF) in the US, EU, Japan and a number of other countries.

In prior Phase I, healthy volunteer studies, 'LYT-100 has shown a differentiated and superior pharmacokinetic profile compared to pirfenidone, suggesting improved efficacy, tolerability and safety, while retaining the same intrinsic pharmacology of pirfenidone. Preclinical research also shows that LYT-100 potently inhibits a range of pro-inflammatory cytokines including IL6, TNF alpha and TGF-beta,' PureTech noted.