PureTech Presents Data for LYT-100 (Deupirfenidone) Supporting Design of Dose-Ranging Trial in Idiopathic Pulmonary Fibrosis (IPF) at European Respiratory Society International Congress 2022
LYT-100 was well-tolerated compared to pirfenidone in a healthy older adult crossover trial, informing dose selection for recently initiated trial in IPF
The data from the Phase 1 trial demonstrated that LYT-100 showed a lower incidence of adverse events (AEs) compared to pirfenidone at comparable exposure levels. Key outcomes of this trial that are supportive of the observed improved tolerability of LYT-100 were reported in January 2022. Additionally, this trial supports the dosages that were selected for the Phase 2 trial of LYT-100, which began in
"These Phase 1 data provide additional evidence of LYT-100's tolerability compared to pirfenidone and further support testing a higher dose of LYT-100 in our dose-ranging clinical trial in patients with IPF," said
LYT-100 is a selectively deuterated form of pirfenidone that is designed to retain the potent and clinically validated anti-fibrotic and anti-inflammatory activity of pirfenidone with a differentiated pharmacokinetic (PK) profile that has translated into favorable safety and tolerability, as demonstrated by data from more than 400 subjects. Pirfenidone is one of the two standard of care treatments approved for IPF, along with nintedanib, both of which are efficacious but associated with significant GI-related tolerability issues. The tolerability issues associated with pirfenidone result in treatment discontinuations and/or dose reductions below the FDA-approved dose of 801 mg three times a day (TID), thereby limiting its effectiveness in patients.
"For a devastating and progressive disease like IPF, more tolerable and effective treatment options are critical to curbing premature discontinuation or sub-optimal dosing," said
Phase 1 safety results in healthy older adults
The Phase 1 trial was a double-blind, randomized, two-period crossover trial of LYT-100 conducted in healthy older adults in the fed state to determine the safety, tolerability and PK parameters of LYT-100 administered TID for three days compared to pirfenidone administered TID for three days under fed conditions. Subjects were randomized to one of two treatment sequences.
Results from the Phase 1 trial were announced in
Dose-ranging trial (ELEVATE) design
The scientific poster also reviews the design of
The global IPF ELEVATE trial has initiated and is enrolling patients. Visit clinicaltrial.gov (NCT05321420) for more details.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis is a terminal, orphan condition that is progressive and characterized by irreversible scarring of the lungs that worsens over time and makes it difficult to breathe. The prognosis of IPF is poor, with the median survival after diagnosis generally estimated at two to five years. Currently available treatment options are associated with significant tolerability issues and dose-limiting toxicities, which can hamper treatment compliance and leave patients and physicians needing new treatment options.
LYT-100 is one of seven therapeutic candidates within
For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including those related to our trial of LYT-100 for the treatment of idiopathic pulmonary fibrosis, the treatment potential of LYT-100 for patients with idiopathic pulmonary fibrosis, including its ability to address a significant unmet need for patients with IPF and certain shortcomings with respect to current standards of care, expectations regarding the potential of clinical data to support clinical development of LYT-100 for indications beyond IPF, our therapeutic candidates and approach towards addressing major diseases, and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended
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