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LYT-100 for Lymphedema

LYT-100 (deupirfenidone) is being advanced for the potential treatment of disorders of lymphatic flow, such as lymphedema. LYT-100 is a deuterated, oral small molecule designed to overcome the challenges associated with pirfenidone, an approved and marketed anti-inflammatory and anti-fibrotic drug. LYT-100, a new chemical entity, retains the pharmacology of pirfenidone but has a differentiated pharmacokinetic (PK) profile, which is designed to enable improved tolerability, less frequent dosing and potentially increased efficacy. PureTech recently completed a Phase 1 multiple ascending dose and food effect study of LYT-100 in healthy volunteers, which demonstrated a favorable tolerability and PK profile for LYT-100. LYT-100 has also been evaluated in preclinical lymphedema models, where it halted progression of lymphedema and reduced swelling volume.

LYT-100 is currently in a Phase 2a proof-of-concept study in patients with breast cancer-related, upper limb secondary lymphedema, a chronic and progressive disorder for which there are no FDA approved drug therapies. The primary endpoint of the study will be safety of LYT-100. As secondary endpoints, PureTech will also study outcome measures of lymphedema, including relative limb volume, bioimpedance spectroscopy – a measure of extracellular fluid change, tonometry, a measure of fibrosis, and serum levels of inflammatory and fibrotic biomarkers. 

PureTech previously completed a Phase 1 randomized, double-blind multiple ascending dose and food effect study, which was designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of LYT-100 in healthy volunteers. The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and PK profile.

Participation in the LYT-100 Phase 2a Study

The randomized, placebo-controlled, Phase 2a proof-of-concept study of LYT-100 is expected to enroll up to 50 patients with breast cancer-related, upper limb secondary lymphedema. The primary endpoints for this trial will be safety and tolerability, with secondary clinical efficacy and biomarker endpoints. The study is not powered to evaluate statistical significance compared to placebo, but PureTech expects to use data emerging from the trial to shape future clinical protocols, including selection of potential future efficacy study endpoints. 

If you are interested in participating in the Phase 2a clinical study of LYT-100, please click here or see the below contact information for the study sites that are currently recruiting.

Institution: Macquarie University Health Science Center
Address: 2 Technology Place, Sydney, NSW
Principal Investigator/Site Staff: Helen Mackie (PI), Louise Kolemeyer (Sub-I), Kristine Nakhel (Coordinator)
Phone: 61298475085, 61298502358, 61298122957
Email: dr.helenmackie@gmail.com, louise.koelmeyer@mq.edu.au, kristine.nakhel@mq.edu.au

Institution: Flinders University Medical Center
Address: Flinders Drive, Bedford Park, Adelaide, SA
Principal Investigator/Site Staff: Ganessan Kichendadasse (PI), Neil Pillar
Phone: 61882044711, 61882044711
Email: ganessan.kichenadasse@sa.gov.au, neil.piller@flinders.edu.au

Institution: Sunshine Coast University Hospital: Sunshine  Coast, QLND
Address: 9 Ochre Way, Buderim, QLD
Principal Investigator/Site Staff: Hong Shue (PI), Georgina Street (Coordinator)
Phone: 61754790000, 61412272917
Email: hong.shue@schoc.com.au, gstreet@usc.edu.au

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