PureTech Health has reported findings from a Phase II clinical trial of LYT-100-COV (deupirfenidone) in post-acute long Covid patients with respiratory complications.
A selectively deuterated form of pirfenidone, LYT-100 is intended to maintain the potent anti-fibrotic and anti-inflammatory activity of pirfenidone.
The placebo-controlled, international, double-blind, randomised trial enrolled 177 subjects with an average age of 55 years.
These subjects had continued respiratory complications after hospital admission for acute Covid-19 that needed supplemental oxygen support.
A three-month change from baseline versus placebo on the six-minute walk test (6MWT) distance was the trial’s primary efficacy endpoint.
6MWT is used to assess functional capacity in various cardio-pulmonary diseases.
According to the findings, no treatment effect was reported following LYT-100 administration though the robust safety and tolerability profile of the therapy reported in prior trials was validated.
Subjects in the treatment and placebo arms showed meaningful improvement in walking distance on the 6MWT as against baseline without any statistically significant differences observed between arms.
Furthermore, LYT-100 was found to be well-tolerated in this relatively sick patients with various comorbidities and concomitant treatments.
No drug-associated serious adverse events (SAEs) or mortality were reported in the trial.
Based on these results, the company will not progress additional trials in this subject population and is on track to commence registration-enabling studies of LYT-100 in idiopathic pulmonary fibrosis (IPF) this month.
PureTech Health founder and CEO Daphne Zohar said: “Although we had hoped to offer a treatment to long Covid patients, these data further strengthen our confidence that LYT-100 has the potential to offer improved tolerability and therefore potentially improved treatment adherence and patient outcomes in IPF, a devastating condition that has been well-studied and where pirfenidone has proven efficacy.”
The company began the Phase II trial of LYT-100 for long Covid respiratory complications and related Sequelae in December 2020.