Puretech Health has plans to conduct a clinical trial to assess its LYT-100 (deupirfenidone) drug candidate to treat serious respiratory complications that persist even after resolution of Covid-19 infection.
A deuterated analogue of pirfenidone, LYT-100 exhibits anti-fibrotic and anti-inflammatory properties.
The drug candidate acts via a multimodal mechanism of action to potentially decrease, delay or prevent lung dysfunction that is known to occur in Covid-19 patients, including those who have recovered.
Expected to start in the third quarter of this year, the global, randomised, placebo-controlled trial will investigate the safety, efficacy and tolerability of LYT-100 in non-critical patients with respiratory complications.
The study is designed to enrol about 150 participants. Treatment duration is up to three months, with primary endpoint being pulmonary function testing.
In addition, the trial will evaluate exploratory endpoints, including pharmacokinetics, acute inflammatory biomarkers, hospitalisation events, imaging and patient-reported outcomes.Top-line data from the study are expected to be available next year.
PureTech R&D Committee member Dennis Ausiello said: “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.”
In March this year, PureTech launched a Phase I trial to study the safety, tolerability and the pharmacokinetic profile of various LYT-100 doses in healthy participants. Results from this trial are set to be available later this year.
The company is also planning to initiate a subsequent proof-of-concept trial in patients with breast cancer-related, upper limb secondary lymphoedema, as well as evaluate the drug candidate to treat other inflammatory and fibrotic conditions.