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.
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By GlobalDataIn 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.
