PureTech Health, a clinical-stage biotherapeutics company, announced the initiation of its global, phase 2 trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related sequelae. LYT-100 is PureTech’s wholly-owned product candidate that’s being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow. The initiation follows the completion of a Phase 1 multiple ascending dose and food effect study for LYT-100, which demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile.
Fibrosis and inflammation are common mechanisms across several lung diseases, and there is increasing data that respiratory complications of SARS-CoV-2 (COVID-19), including shortness of breath, begin during the acute phase of illness and will persist as lung fibrosis develops. Similar respiratory complications caused by Severe Acute Respiratory Syndrome (SARS) lasted for years in many survivors. according to an enquiry letter published within the Journal of the American Medical Association (JAMA), quite 40 percent of COVID-19 survivors assessed in an Italian study still reported shortness of breath a mean of 60 days following symptom onset. These data suggest that an enormous percentage of COVID-19 survivors could even be in peril for respiratory complications and other sequelae, which can be a condition that’s now colloquially mentioned as “Long COVID.”
“COVID-19 could also be a worldwide public health crisis with severe and long-lasting effects. Patients around the world have reported persistent suffering, including serious respiratory complications which can last for months after the acute infection resolves, and – even with vaccines – there’s great a requirement for treatment options for Long COVID,” said Toby Maher, M.D., Ph.D., professor of clinical medicine and director of interstitial lung disease at Keck School of medicine of the University of Southern California and thus the PI on PureTech’s Long COVID phase 2 trial. “The anti-fibrotic and anti-inflammatory properties of LYT-100 hold potential for treating a spread of respiratory conditions, including the long-lasting health burden associated with post-acute COVID-19. i’m encouraged by the data generated with LYT-100 thus far , which i’m excited to be involved during this trial addressing a critically important public health need within the present COVID-19 pandemic.”
LYT-100 could also be a deuterated, oral small molecule designed to beat 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’s associated with significant tolerability issues and dose-limiting toxicities. LYT-100, a replacement chemical entity, retains the pharmacology of pirfenidone but features a differentiated PK profile, which is supposed to enable improved tolerability, less frequent dosing and potentially increased efficacy.
PureTech’s global, randomized, double-blind, placebo-controlled phase 2 trial is supposed to guage the efficacy, safety and tolerability of LYT-100 in adults with post-acute COVID-19 respiratory complications. the primary endpoint of the trial are getting to be the six-minute walk test distance. Secondary endpoints, including pharmacokinetics, inflammatory biomarkers, imaging and patient-reported outcomes including dyspnea and thus the 36-Item Short Form Health Survey, also are going to be evaluated. The study has initiated in both the us and Europe, and results are expected within the second half of 2021.
LYT-100 is PureTech’s most advanced wholly-owned product candidate. A deuterated kind of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow, including lung dysfunction conditions (e.g., IPF, unclassifiable interstitial lung diseases (uILDs), Long COVID respiratory complications and related sequelae) and lymphedema. PureTech completed a phase 1 multiple ascending dose and food effect trial evaluating LYT-100 in healthy volunteers and located it to be well-tolerated within the least doses tested. PureTech has initiated a phase 2 trial evaluating LYT-100 as a possible treatment for Long COVID respiratory complications and related sequelae. PureTech also intends to initiate a phase 2a proof-of-concept study evaluating LYT-100 in patients with breast cancer-related, upper limb secondary lymphedema in Q4 2020. PureTech is additionally advancing LYT-100 for the treatment of IPF and is planning registration-enabling studies.
About Toby Maher :
Toby Maher is British Lung Foundation Chair in Respiratory Research and National Institute for Health Research (NIHR) Clinician Scientist. He is Professor of Interstitial Lung Disease and heads up the Fibrosis Research Group at the National Heart and Lung Institute, Imperial College, London. He is also an honorary Consultant Respiratory Physician on the Interstitial Lung Disease Unit, Royal Brompton Hospital and is Director of the NIHR Respiratory CRF and Director of Respiratory Research at Royal Brompton Hopsital.
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