Conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis
Conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis
Our programs 1
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
LYT-100
Deupirfenidone
Idiopathic pulmonary fibrosis (IPF)

2

IPF

~120K in US

~110K in EU5


Therapeutic candidate being advanced for the potential treatment of conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis (IPF). Also being advanced under the Animal Rule for medical countermeasures; plans underway to study LYT-100 in progressive fibrosing interstitial lung disease (PF-ILDs) as well as other fibrotic conditions where there is human data with pirfenidone suggestive of clinical benefit.

Phase completedPhase in progress
1 We have an active IND on file with the FDA for LYT-100. The FDA and corresponding regulatory authorities will ultimately review our clinical results and determine whether our wholly-owned therapeutic candidates are safe and effective. No regulatory agency has made any such determination that LYT-100 is safe or effective for use by the general public for any indication.

Conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis

Our most advanced clinical-stage therapeutic candidate, LYT-100 (deupirfenidone), is currently in development for idiopathic pulmonary fibrosis (IPF), which is a rare, progressive and fatal disease. We are also developing LYT-100 for medical countermeasures under the FDA Animal Rule, which allows for the approval of drugs based on well-controlled animal models when human efficacy studies are not feasible.8 PureTech may be eligible to receive a priority review voucher from the FDA for a medical countermeasure application upon approval. LYT-100 also has the potential to address multiple underserved diseases, including progressive fibrosing interstitial lung diseases, a group of lung diseases closely related to IPF, as well as other fibrotic conditions where there is human data with pirfenidone suggestive of clinical benefit. LYT-100 is a deuterated form of pirfenidone and is designed to retain the beneficial pharmacology and clinically-validated efficacy of pirfenidone with a highly differentiated pharmacokinetic profile that has translated into favorable tolerability in multiple clinical studies and has the potential to keep patients on treatment longer to enable more optimal disease management.

  • Key Points of Innovation & Differentiation
    • LYT-100 has shown a 50% reduction in gastro-intestinal (GI)-related adverse events (AEs) in a head-to-head study versus pirfenidone. We believe the differentiated tolerability profile of LYT-100 will address one of the key reasons that patients on the current standard of care treatments must dose reduce, discontinue or switch from otherwise efficacious treatments.2,3 We have also been able to dose LYT-100 at a higher exposure level, but with a lower Cmax, than the FDA-approved dosage of pirfenidone, potentially enabling improved efficacy. Given this, we believe LYT-100 has the potential to become standard of care and to become a backbone therapy in the treatment for IPF.
    • Pirfenidone (Esbriet®) is approved for the treatment of IPF in the US and other countries. Pirfenidone has been shown to slow the decline of lung function and research suggests it extends life by approximately 3 years in patients with IPF.4 It is one of two standard of care treatments for IPF, with nintedanib (OFEV®) being the other.
  • Program Discovery Process by the PureTech Team
  • Patient Need & Market Potential
  • Milestones Achieved & Development Status
  • Expected Milestones
  • Intellectual Property
1 Our program in medical countermeasures is preclinical-stage and is subject to the Animal Rule, which allows for the approval of drugs based on validated animal models when human efficacy studies are not feasible. The use of the Animal Rule is intended for drugs and biological products developed to reduce or prevent serious or lifethreatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological or nuclear substances.
2 Cottin, V., Koschel, D., Günther, A., Albera, C., Azuma, A., Sköld, C. M., Tomassetti, S., Hormel, P., Stauffer, J., Kirchgaessler, K., & Maher, T. M. (2018). Long-term safety
of pirfenidone: results of the prospective, observational PASSPORT study. ERJ Open Research, 4(4), 00084–02018. https://doi.org/10.1183/23120541.00084-2018
3 Dempsey, T., Payne, S. C., Sangaralingham, L. R., Yao, X., Shah, N., & Limper, A. H. (2021). Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients
with Idiopathic Pulmonary Fibrosis. Annals of the American Thoracic Society, 18(7), 1121–1128. https://doi.org/10.1513/annalsats.202007-901oc
4 Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary
Fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17 -S24. https://doi.org/10.18553/jmcp.2017.23.3-b.s17.
5 United Kingdom, France, Germany, Italy and Spain
6 GlobalData Epidemiology and Market Size Search
7 Roche 2022 Annual Report and Boehringer Ingelheim 2022 Financial Results
8 Our program in medical countermeasures is preclinical-stage and is subject to the Animal Rule, which allows for the approval of drugs based on validated animal models when human efficacy studies are not feasible. The use of the Animal Rule is intended for drugs and biological products developed to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological or nuclear substances. 
LYT-100 maintains the pharmacology of pirfenidone but has a highly differentiated PK profile that has translated into favorable tolerability, as demonstrated by data from multiple human clinical studies. Based on prior work with pirfenidone, a substantial amount of preclinical and clinical data support LYT-100’s broader potential in inflammatory and fibrotic conditions, including IPF. We are also exploring the potential evaluation of LYT-100 in medical countermeasures and other organ system fibrosis.

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