Duyuru • Apr 02

PureTech Health plc Announces Publication of Phase 2b ELEVATE IPF Trial Results

PureTech Health plc announced the publication of results from the Phase 2b ELEVATE IPF trial of deupirfenidone for the potential treatment of idiopathic pulmonary fibrosis (IPF) in The American Journal of Respiratory and Critical Care Medicine. Deupirfenidone 825 mg TID monotherapy significantly slowed lung function decline versus placebo at 26 weeks in people with idiopathic pulmonary fibrosis (adjusted mean FVC difference 91 mL; p=0.02), approaching the lung function change expected in normal, healthy aging. First industry-sponsored IPF trial to include a current standard-of-care treatment as an active comparator in addition to a placebo arm, strengthening interpretation of efficacy and safety findings. PureTech's Founded Entity, Celea Therapeutics, is working to complete a financing to enable the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026. The results from this trial informed the design of the upcoming Phase 3 SURPASS-IPF trial, which will evaluate deupirfenidone 825 mg three times a day (TID) monotherapy as compared to pirfenidone 801 mg TID monotherapy, in a head-to-head study powered to test for superiority. Highlights from the publication have been presented in various scientific forums throughout the course of 2025 and include: 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 FVC (adjusted difference 91 mL; p=0.02). A secondary analysis of FVCpp also showed a statistically significant benefit (p=0.01). 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). Although not included in the publication, data from the ongoing Phase 2b ELEVATE IPF open-label extension 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). 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. The Phase 2b ELEVATE IPF trial 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, which is ongoing. The primary endpoint of the trial was the rate of decline in Forced Vital Capacity (FVC) for the combined deupirfenidone arms versus placebo over the 26-week treatment period. FVC is a measure of the maximum amount of air (in mL) that an individual can forcibly exhale after fully inhaling. It is a standard measurement in clinical trials for IPF and is used to assess disease progression as well as to predict mortality. A prespecified Bayesian analysis was utilized to assess the primary endpoint and provided a posterior probability, which is the probability of superior efficacy for deupirfenidone compared to placebo. This also allowed for augmentation of the placebo arm with placebo data from historical IPF trials. This approach enabled a more patient-centric clinical trial design by minimizing the number of trial participants exposed to placebo – a key consideration since IPF is progressive and fatal – while delivering a robust, placebo-controlled dataset. Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019. Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from an ongoing open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.

Biotechs Sektör Büyümesi	17.04%
Gelir büyüme oranı	-27.85%
Özkaynak getirisi	-36.01%
Net Marj	-2,355.42%
Son Kazanç Güncellemesi	31 Dec 2025

Tarih	Gelir	Kazançlar	G+A Giderleri	Ar-Ge Giderleri
31 Dec 25	5	-110	47	0
30 Sep 25	6	-30	58	0
30 Jun 25	6	51	69	0
31 Mar 25	6	52	70	0
31 Dec 24	5	54	71	0
30 Sep 24	3	-14	63	0
30 Jun 24	0	-82	55	0
31 Mar 24	2	-74	54	0
31 Dec 23	3	-66	53	0
30 Sep 23	8	-56	58	0
30 Jun 23	12	-47	64	0
31 Mar 23	14	-49	62	0
31 Dec 22	16	-50	61	0
30 Sep 22	17	-32	58	-55
30 Jun 22	19	-14	55	110
31 Mar 22	18	-37	56	110
31 Dec 21	17	-61	57	0
30 Sep 21	14	-127	55	137
30 Jun 21	11	-193	54	0
31 Mar 21	11	-94	52	0
31 Dec 20	12	6	49	82
30 Sep 20	12	239	50	0
30 Jun 20	12	472	52	0
31 Mar 20	11	446	55	0
31 Dec 19	10	421	59	0
30 Sep 19	15	229	56	0
30 Jun 19	20	37	53	0
31 Mar 19	20	-3	50	0
31 Dec 18	21	-44	47	0
30 Sep 18	14	9	48	0
30 Jun 18	7	61	48	0
31 Mar 18	5	44	47	0
31 Dec 17	3	26	46	0
30 Sep 17	4	-17	43	-8
30 Jun 17	5	-61	40	-15
31 Mar 17	5	-55	39	-8
31 Dec 16	4	-49	37	0
30 Sep 16	3	-54	39	14
30 Jun 16	1	-59	40	28
31 Mar 16	6	-49	38	23
31 Dec 15	12	-39	36	19
30 Sep 15	12	-37	31	15
30 Jun 15	12	-35	26	10

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/05/25 23:01
Gün Sonu Hisse Fiyatı	2026/05/21 00:00
Kazançlar	2025/12/31
Yıllık Kazançlar	2025/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Peter Welford	Jefferies LLC
Miles Dixon	Peel Hunt LLP
Edward Tenthoff	Piper Sandler Companies

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