Business
PRTC LYT-100 Shows PK & Tolerability Ph1 POC
PRTC LYT-100 Shows PK & Tolerability Ph1 POC.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 6517F\n PureTech Health PLC\n 18 November 2020\n \n \n \n \n \n 18\n \n \n November 2020\n \n \n \n PureTech Health plc\n \n \n \n \n \n PureTech's LYT-100 (Deupirfenidone) Demonstrates Tolerability and Pharmacokinetic Proof-of-Concept in Phase 1 Multiple Ascending Dose and Food Effect Study \n \n \n \n \n \n LYT-100 was well-tolerated at all pre-specified doses, so an additional cohort of 1000 mg twice a day was added, which was also well-tolerated\n \n \n \n \n \n \n In a previous study, a single dose of 801 mg\n \n \n of LYT-100 \n \n \n yielded greater exposure than a single dose of 801 mg (FDA-approved dose) of \n \n \n pirfenidone\n \n \n \n \n \n \n \n LYT-100\n \n \n to be advanced for conditions involving inflammation and fibrosis and disorders of lymphatic flow, including idiopathic pulmonary fibrosis, Long COVID and lymphedema \n \n \n \n \n \n \n PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) (\"PureTech\" or the \"Company\"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the completion of a Phase 1 multiple ascending dose and food effect study for LYT-100 (deupirfenidone). The study demonstrated favorable proof-of-concept for LYT-100's tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. LYT-100 is PureTech's wholly-owned product candidate that is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow.\n \n \n \n \n \n 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. Pirfenidone is currently approved for the treatment of idiopathic pulmonary fibrosis (IPF), but it is associated with significant tolerability issues and dose-limiting toxicities leading approximately 50% of patients to discontinue use, dose adjust or switch therapies, which results in suboptimal disease management.[1] LYT-100, a new chemical entity, retains the pharmacology of pirfenidone but has a differentiated PK profile, which is designed to enable improved tolerability, less frequent dosing and...