LYT-100

Dedicated to advancing transformative treatments for people with serious respiratory diseases

Positive topline Phase 2b results for deupirfenidone announced in December 2024. Read the press release HERE.

Publication in BMC Pulmonary Medicine highlighting untold experiences of people living with IPF. Read the press release HERE.

< PORTFOLIO

Description

Conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis

PURETECH ECONOMIC INTEREST¹

100% Equity

Stage of Development

Phase 2b completed

¹ We have an active IND on file with the FDA for deupirfenidone. The FDA and corresponding regulatory authorities will ultimately review our clinical results and determine whether deupirfenidone is safe and effective. No regulatory agency has made any such determination that deupirfenidone is safe or effective for use by the general public for any indication.

Conditions involving inflammation and fibrosis, including idiopathic pulmonary fibrosis

Celea Therapeutics (Celea) is a clinical-stage biopharmaceutical company dedicated to delivering transformative treatments for people with serious respiratory diseases. Its lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to establish a new standard of care (SOC) for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.

Patient Need
- IPF is a rare, progressive, and fatal lung disease affecting more than 233,000 people in the U.S. and EU5.^1-7 Patients experience irreversible scarring of lung tissue that leads to a steady and ultimately fatal decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.⁸
- There are three FDA-approved therapies for the treatment of IPF. Historically, the uptake of and adherence to approved treatments has been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received approved anti-fibrotic treatment as of 2019.⁹
- There remains a critical need for therapies that can meaningfully slow or stabilize lung function while maintaining tolerability, enabling broader adoption and continuation of treatment.
Early Development & PureTech Innovation
- Deupirfenidone is a deuterated form of pirfenidone. Pirfenidone is one of the three existing FDA-approved therapies. PureTech acquired deupirfenidone in July 2019 from Auspex Pharmaceuticals, Inc. (Auspex; now a wholly owned subsidiary of Teva Pharmaceuticals) based on insights gained internally and via unpublished findings through our network of collaborators. The deuteration technology was pioneered by Auspex, who achieved the first-ever FDA approval for a deuterated drug with Austedo®.
- PureTech has since applied its own innovation framework to the program, conducting critical de-risking studies to define the optimal path forward into late-stage development. PureTech has demonstrated that strategically replacing hydrogen atoms with deuterium at the site of metabolism enhances the beneficial pharmacology and clinically-validated efficacy of pirfenidone while maintaining a favorable tolerability profile. Deupirfenidone may overcome the tolerability ceiling that limits current therapies and enable stabilization of lung function. Based on this work, PureTech has generated proprietary intellectual property around deupirfenidone.
Milestones Achieved & Development Status
- PureTech successfully completed the Phase 2b ELEVATE IPF trial, which was a global, randomized, double-blind, active- and placebo-controlled, dose-ranging trial designed to evaluate the efficacy, tolerability, safety, and dosing regimen of deupirfenidone (LYT-100) in patients with IPF compared to placebo. 257 participants were randomized in a ratio of 1:1:1:1 to receive either 550 mg of deupirfenidone, 825 mg of deupirfenidone, 801 mg of pirfenidone or placebo three times a day (TID) for 26 weeks. Participants who completed the trial had the option to enroll in an open-label extension (OLE), which is ongoing. Results from the Phase 2b ELEVATE IPF trial and open-label extension position deupirfenidone as a Phase 3-ready asset with the potential to redefine the treatment paradigm in IPF and included:
  - Primary and key secondary endpoints achieved: Deupirfenidone demonstrated a 98.5% and 99.6% posterior probability of superiority vs. placebo in slowing forced vital capacity (FVC) and forced vital capacity percent predicted (FVCpp) decline, respectively, at 26 weeks based on the prespecified Bayesian analysis.
  - Statistically significant and clinically meaningful preservation of lung function: Deupirfenidone 825 mg TID as a monotherapy significantly slowed lung function decline versus placebo at 26 weeks as measured by mean Forced Vital Capacity (FVC) (-21.5 mL vs. -112.5 mL, respectively; adjusted difference 91 mL; p=0.02). A secondary analysis of FVC percent predicted (FVCpp) also showed a statistically significant benefit (p=0.01). (Figure 1)
  - Lung function decline approached the range expected with healthy aging: In the deupirfenidone 825 mg TID arm, the rate of FVC decline over 26 weeks (-21.5 mL) approached the normal physiological decline expected in healthy older adults (approximately -15.0 mL to -25.0 mL).^10,11 Data from the ongoing Phase 2b ELEVATE IPF open-label extension (OLE) show that this treatment effect was maintained out to at least 52 weeks, with participants experiencing a decline in FVC of -32.8 mL. This is also similar to the expected natural decline in lung function in healthy older adults over that time (approximately -30.0 mL to -50.0 mL).⁴ (Figure 2)
  - Potential benefit in patients transitioning from standard of care: Participants who completed 26 weeks of placebo or pirfenidone treatment in the randomized portion of the trial and then switched to deupirfenidone for an additional 26 weeks in the OLE achieved stabilization of lung function. Those who switched from placebo to deupirfenidone 825 mg TID (n=17) had a mean change in FVC of +20.0 mL, while those who switched from pirfenidone to deupirfenidone 825 mg TID (n=16) had a mean change in FVC of -23.1 mL.¹² (Figure 3)
  - Delay in disease progression: Time to IPF progression, defined as an absolute decline in FVCpp of ≥5% or death through 26 weeks, was significantly delayed in patients receiving deupirfenidone 825 mg TID compared with placebo (HR 0.439; p=0.0023).
  - Greater drug exposure without sacrificing tolerability: Pharmacokinetic data show that deupirfenidone 825 mg TID results in an approximately 50% greater drug exposure compared to pirfenidone 801 mg TID (the highest FDA-approved dose). Importantly, the overall incidence of adverse events (AEs) with deupirfenidone 825 mg TID was similar to that of pirfenidone 801 mg TID (85.9% vs. 84.1%, respectively), and AEs were generally mild to moderate. The percentage of patients who remained on deupirfenidone 825 mg TID for 26 weeks (78.1%) was similar to the percentage of patients remaining on placebo (80.0%). Taken together, these data suggest that the higher exposure and improved efficacy observed with deupirfenidone 825 mg TID were achieved without sacrificing tolerability.
- Additional milestones achieved include the following:
  - In April 2026, PureTech announced the publication of results from the Phase 2b ELEVATE IPF trial of deupirfenidone in The American Journal of Respiratory and Critical Care Medicine.
  - In the February 2026 post-period, PureTech announced that the FDA and European Commission had granted Orphan Drug Designation to deupirfenidone for the treatment of IPF. This is an important validation of the program’s potential and a meaningful catalyst, as this designation provides both financial and commercial advantages for the development of deupirfenidone.
  - In December 2025, PureTech announced the successful completion of the End-of-Phase 2 meeting with the FDA regarding the development of deupirfenidone for the treatment of IPF. The pivotal Phase 3 SURPASS-IPF trial will be a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity (FVC) at week 52, which will assess the superiority of deupirfenidone compared with pirfenidone. Based on FDA feedback, PureTech believes that the results from the Phase 3 trial, if successful, and supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone
  - In September 2025, PureTech presented new data from the OLE at the European Respiratory Society (ERS) Congress (Figure 3).
  - In May 2025, PureTech presented initial data from the ongoing OLE (at the American Thoracic Society (ATS) International Conference (Figure 2).
Expected Milestones
- Celea Therapeutics has secured sufficient non-binding commitments from external investors, in addition to participation from PureTech, such that the fundraising is substantially complete, subject to continued negotiations. While mindful of macro factors, Celea is targeting to close the financing by early in the third quarter of 2026. The financing is intended to support the Phase 3 SURPASS-IPF trial, which Celea expects to commence in close proximity to closing the financing.
Intellectual Property
- Deupirfenidone is protected by a broad and layered IP portfolio. As of December 31, 2025, there are 12 families of intellectual property within this patent portfolio, including eleven families of patent filings that are owned by PureTech and one (1) family that is owned by Teva Pharmaceuticals and exclusively licensed to PureTech, which intellectual property covers deuterated pirfenidone compounds, compositions, and formulations, as well as therapeutic uses therefore, including coverage of deupirfenidone (LYT-100) and its use to treat idiopathic pulmonary fibrosis and other interstitial lung diseases. This intellectual property portfolio comprises six (6) issued U.S. patents which are expected to expire in 2028, one (1) issued patent which is expected to expire in 2035, 13 pending U.S. patent applications, which if issued, are expected to expire 2039 through 2046, two (2) international PCT applications, 41 pending foreign applications and 25 issued patents in foreign jurisdictions.

Deupirfenidone is an investigational drug not approved by any regulatory authority.
¹ Raghu, Ganesh, et al. “Incidence and prevalence of idiopathic pulmonary fibrosis in US adults 18–64 years old.” European Respiratory Journal 48.1 (2016): 179-186
² Raghu, Ganesh, et al. “Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001–11.” The lancet Respiratory medicine 2.7 (2014): 566-572
³ Kreuter, Michael, et al. “Epidemiology, healthcare utilization, and related costs among patients with IPF: results from a German claims database analysis.” Respiratory Research 23.1 (2022): 62
⁴ Snell, N., et al. “P272 Epidemiology of idiopathic pulmonary fibrosis in the UK: findings from the British lung foundation’s ‘respiratory health of the nation’ project.” (2016): A236-A236
⁵ French guidelines PNDS
⁶ Rodríguez-Nieto, Maria Jesus, et al. “Economic burden of idiopathic pulmonary fibrosis in Spain: a prospective real-world data study (OASIS study).” PharmacoEconomics 41.8 (2023): 999-1010.
⁷ Iommi, Marica, et al. “Occurrence of idiopathic pulmonary fibrosis in Italy: latest evidence from Real-World data.” International Journal of Environmental Research and Public Health 19.5 (2022): 2510.
⁸ 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
⁹ Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128
¹⁰ FVC decline at 6 months was estimated assuming linear decline over time.
¹¹ Valenzuela, C., Bonella, F., Moor, C., Weimann, G., Miede, C., Stowasser, S., & Maher, T. (2024, September). Decline in forced vital capacity (FVC) in subjects with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) compared with healthy references [Poster presentation]. European Respiratory Society International Congress, Vienna, Austria; and Luoto, J., Pihlsgård, M., Wollmer, P., & Elmståhl, S. (2019). Relative and absolute lung function change in a general population aged 60–102 years. European Respiratory Journal, 53(3), 1701812. https://doi.org/10.1183/13993003.01812-2017
¹² Part B analysis is based on switch patients (those who completed 26 weeks of placebo or pirfenidone in Part A and then were re-randomized to receive deupirfenidone 825 mg TID in Part B). Patients were re-baselined to the last available FVC measurement obtained prior to the first administration of deupirfenidone 825 mg TID in Part B. Observed mean (SE) values are presented over time as of May 9, 2025.