PureTech (PRTC) Presents Additional Phase 1 Data for LYT-100

PureTech Health plc (Nasdaq: PRTC) today announced the presentation of additional data for PureTech’s LYT-100 (deupirfenidone) at the American Thoracic Society 2022 International Conference. The data were shared in a scientific poster session and detailed the outcomes of a study in healthy older adults showing that LYT-100 demonstrated a lower incidence of adverse events (AEs) compared to pirfenidone at comparable exposure levels. Key outcomes of this study that are supportive of the observed improved tolerability of LYT-100 were reported in January 2022. The data support the upcoming registration-enabling studies in which PureTech plans to investigate LYT-100 in patients with idiopathic pulmonary fibrosis (IPF) at the planned 550 mg three times daily dose (TID) as well as a dose with a higher total drug exposure than the currently approved dose of pirfenidone to evaluate if higher exposure could translate into improved efficacy.

Pirfenidone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF but is associated with significant tolerability issues that LYT-100, as a deuterated form of pirfenidone, is intended to reduce. PureTech intends to advance LYT-100 into late-stage clinical development for the treatment of IPF using a 505(b)(2) development path, beginning with a dose-ranging study evaluating six months of treatment with LYT-100 with topline results expected by the end of 2023.

“Although approved antifibrotics for the treatment of IPF delay the progression of lung fibrosis and increase life expectancy, a large proportion of patients are unable to tolerate these treatments, leading to premature discontinuation or sub-optimal dosing,” said Michael Chen, Ph.D., Head of Innovation at PureTech Health. “These data further support the favorable tolerability profile of LYT-100, which has been studied in over 400 patients and healthy volunteers to date. LYT-100 is designed to retain the pharmacological activity of pirfenidone, but has a differentiated pharmacokinetic profile which enables a lower peak systemic concentration (Cmax), while still retaining AUC bioequivalence compared with the standard dosing of pirfenidone. We believe the lower Cmax we demonstrated at the 550 mg TID dose accounted for the lower incidence of adverse events we observed in the study.”

The double-blind, randomized, crossover Phase 1 study evaluated the tolerability of LYT-100 550 mg TID versus pirfenidone 801 mg TID in 49 healthy older adults aged 60-79, an age group consistent with that of the IPF patient population. As previously announced, the study was supportive of an improved tolerability profile for LYT-100 with 38% fewer subjects treated with LYT-100 experiencing any AEs compared with those treated with pirfenidone (30.4% vs. 48.9%). The poster presented today details the incidence of AEs in the study population including the reduction in incidence of AEs in LYT-100 vs. pirfenidone administration in both fed and fasted subjects. Notably, LYT-100 at 550 mg TID (fed state) dose met the criteria for bioequivalence for exposure compared to the FDA-approved dosage of pirfenidone – 801 mg TID – but with a lower Cmax. Higher dosages of LYT-100 may provide enhanced antifibrotic and anti-inflammatory activity.

The scientific poster presented today is available at https://puretechhealth.com/LYT-100-ATS2022-poster.

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