PureTech Health Plc engages in the provision of differentiated medicines for devastating diseases, including inflammatory, fibrotic and immunological conditions, intractable cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders. It operates through the following segments: Internal, Controlled Founded Entities, Non-Controlled Founded Entities, and Parent Company and Others. The Internal segment focuses on immunological, fibrotic, and lymphatic system mechanisms. The Controlled Founded Entities segment is composed of the group’s subsidiaries that are currently consolidated operational subsidiaries that either have or have plans to hire independent management teams and currently have already raised, or are currently in the process of raising, third-party dilutive capital. The Non-Controlled Founded Entities segment includes companies wherein the group no longer holds majority voting control as a shareholder and no longer has the right to elect a majority of the members of the subsidiaries’ Board of Directors. The Parent Company and Other segment represents activities that are not directly attributable to the operating segments, such as the activities of the parent, corporate support functions and certain research and development support functions that are not directly attributable to a strategic business segment as well as the elimination of intercompany transactions. The company was founded by Robert S. Langer Jr., Bennett M. Shapiro, and Daphne Zohar on May 8, 2015 and is headquartered in Boston, MA.
Clinical Trials
11
3 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2001
Active, not recruiting
3
27.3%
Completed
5
45.5%
Recruiting
1
9.1%
Terminated
2
18.2%
No approval data available
- The FDA granted fast track designation to LYT-200 plus a hypomethylating agent for relapsed or refractory high-risk myelodysplastic syndromes, developer PureTech Health reported. - The designation followed an end-of-phase 1 meeting supporting a planned randomized phase 2 STRIDE-MDS trial of about 125 patients. - Phase 1b data in 11 efficacy-evaluable patients at 12 mg/kg plus an HMA showed a 45.5% overall response rate and no dose-limiting toxicities.
- PureTech Health and its Founded Entity Gallop Oncology completed an End-of-Phase 1 meeting with the FDA and received Fast Track designation for LYT-200 in relapsed/refractory high-risk myelodysplastic syndromes. - The randomized, double-blind, placebo-controlled Phase 2 STRIDE-MDS trial will enroll approximately 125 patients randomized 2:2:1 to LYT-200 at 12 mg/kg, 7.5 mg/kg, or placebo, each with a hypomethylating agent. - In the completed Phase 1b trial, efficacy-evaluable patients receiving LYT-200 12 mg/kg plus an HMA (n=11) achieved a 27.3% complete response rate and a 45.5% overall response rate, with no dose-limiting toxicities. - LYT-200 is a fully human monoclonal antibody targeting galectin-9, a mutation-agnostic approach intended to reach the majority of R/R HR-MDS patients who lack an actionable mutation.
- Celea Therapeutics completed a $180 million financing round with top-tier investors including RA Capital Management, Leaps by Bayer, and PureTech Health to advance deupirfenidone. - Proceeds will fund the SURPASS-IPF trial, the first head-to-head Phase 3 study in idiopathic pulmonary fibrosis, comparing deupirfenidone directly against pirfenidone with initiation planned for early Q3 2026. - Deupirfenidone, a deuterated next-generation antifibrotic, demonstrated potential to stabilize lung function decline over 26 weeks in the Phase 2b ELEVATE IPF trial with a favorable safety profile. - IPF remains a rare, fatal lung disease with median survival of two to five years and no cure, with only approximately 25% of U.S. patients ever receiving treatment as of 2019.
- PureTech Health reported positive Phase 1b trial results for LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, demonstrating complete responses in heavily pretreated patients with relapsed/refractory high-risk myelodysplastic syndrome and acute myeloid leukemia. - The therapy showed a favorable safety profile across 101 patients with no dose-limiting toxicities, infusion-related reactions, or treatment-related serious adverse events, while achieving response rates of 45.5% in MDS and 42.3% in AML patients. - Based on the compelling data, particularly in high-risk MDS where treatment options are extremely limited, Gallop Oncology plans to engage with the FDA to discuss a subsequent trial design with potential to support registration. - LYT-200 targets galectin-9, an important oncogenic driver and immunosuppressor in cancer, offering a novel therapeutic approach for patients with limited treatment options in these aggressive blood cancers.
- Nektar Therapeutics' rezpegaldesleukin showed promise in treating severe alopecia areata but narrowly missed statistical significance in its Phase 2b Rezolve-AA trial. - The company attributed the statistical miss to four ineligible patients, claiming the drug met its primary endpoint when these participants were excluded from analysis. - Rezpegaldesleukin demonstrated a 28-30% reduction in hair loss scores compared to 11% for placebo, with a favorable safety profile and low dropout rates. - Despite the mixed results, Nektar plans to advance the drug into Phase 3 testing next year, targeting an autoimmune condition affecting 2% of the population with limited treatment options.
- PureTech Health experienced stock gains following a regulatory meeting with the FDA after completing a Phase II clinical trial. - The FDA meeting represents a key regulatory milestone for the biotechnology company's drug development program. - The positive market response suggests investor confidence in the company's clinical progress and regulatory pathway forward.
- PureTech Health completed a successful end-of-phase-2 meeting with the FDA for deupirfenidone, a deuterated form of pirfenidone, receiving support for advancement into a pivotal phase 3 trial. - The FDA endorsed a streamlined 505(b)(2) regulatory pathway and indicated that successful results from a single phase 3 study could be sufficient to support potential registration. - The phase 3 SURPASS-IPF trial will compare deupirfenidone 825 mg three times daily to pirfenidone 801 mg three times daily in adults with IPF, with initiation planned for the first half of 2026. - Previous phase 2b ELEVATE IPF trial data showed deupirfenidone patients experienced slower lung function decline compared to pirfenidone or placebo groups, with a 91 mL difference between deupirfenidone and placebo at 26 weeks.
- Gallop Oncology's first-in-class anti-galectin-9 monoclonal antibody LYT-200 demonstrated initial median overall survival of 13.2 months in combination therapy, significantly exceeding the typical <2.5 months expected in relapsed/refractory AML patients. - The Phase 1b trial showed favorable safety with no LYT-200-related serious adverse events and achieved a 38% complete response rate at the proposed Phase 2 dose of 12 mg/kg in heavily pretreated patients. - LYT-200 showed activity across diverse high-risk mutations including KRAS, NRAS, JAK2, and KIT, supporting its mutation-agnostic mechanism and potential broad applicability in AML treatment. - The company plans to advance toward a potentially registrational Phase 2 trial and engage with regulatory authorities once overall survival data fully mature in the first half of 2026.
- Vedanta Biosciences will lay off nearly 20% of its staff after experimental microbiome therapy VE202 failed to meet its primary endpoint in a Phase 2 ulcerative colitis study. - The VE202 treatment, licensed by Johnson & Johnson in 2015, was not significantly better than placebo at improving disease signs on endoscopic examination after eight weeks of treatment. - The company will now focus resources on VE303, a microbiome therapy in Phase 3 testing for recurrent C. diff infections, and a preclinical therapy for antibiotic-resistant bacterial infections. - The failure adds to mounting evidence of challenges in developing microbiome-based therapies for inflammatory bowel disease, following similar setbacks from competitors like Seres Therapeutics.
- Vedanta Biosciences announced that VE202 did not meet the primary endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study for mild-to-moderate ulcerative colitis treatment. - The microbiome-based therapy was well tolerated with no treatment-related serious adverse events, but showed no statistical difference from placebo in response rates. - The company is redirecting resources to its lead program VE303, which demonstrated over 30% reduction in C. difficile recurrence risk and is currently in Phase 3 trials. - VE303 has received FDA Fast Track and Orphan Drug designations and could become the first approved live biotherapeutic product for any indication.
