LYT-100 in Patients With BCRL

Phase 2 Terminated 50 enrolled PureTech Novotech (Australia) Pty Limited · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema

Timeline

Start: 2020-03-01
Primary completion: 2022-09-09
Completion: 2022-09-09

Outcome

Met primary endpoint

Stopped: “Primary objective/endpoint has been established, will not pursue development of the disease indication further”

release “Completed a Phase 2a trial of LYT-100 in patients with breast cancer-related, upper limb secondary lymphedema, which met the primary endpoint of safety and tolerability” puretechhealth.com ↗

Publications

Chen MC, Korth CC, Harnett MD, Elenko E, Lickliter JD. A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases. Clin Pharmacol Drug Dev. 2022 Feb;11(2):220-234. doi: 10.1002/cpdd.1040. Epub 2021 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deupirfenidone	Unknown	—	—