zamaglutenase (TAK-062) / Takeda - LARVOL DELTA

ASSESSMENT OF HISTOLOGIC ENDPOINTS AND PERFORMANCE IN THE TAK-062 PHASE 2 TRIAL (UEGW 2025) - P2 | "Although TAK-062 did not demonstrate efficacy in the phase 2 trial, learnings from this study emphasize the need for well-trained readers with clear scoring criteria to help to minimize variability in quantitative scoring. Furthermore, Vh:Cd shows good performance and is recommended as a key endpoint for assessing changes in gut architecture in celiac disease studies."

P2 data • Celiac Disease • Immunology

EFFICACY AND SAFETY OF THE GLUTENASE TAK-062 IN PATIENTS WITH CELIAC DISEASE ON A GLUTEN-FREE DIET: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY (UEGW 2025) - P2 | "TAK-062 did not demonstrate efficacy for improving symptoms or histology in patients with ongoing active CeD on a GFD. Vh:Cd significantly worsened in the TAK-062 arm, with a significant difference between groups; possible reasons for this are under investigation. Stable Vh:Cd in the placebo arm indicates that SIGE successfully mitigates trial-related disease improvements previously observed in similar cohorts."

Clinical • P2 data • Celiac Disease • Immunology

PSYCHOMETRIC VALIDATION OF THE CELIAC DISEASE SYMPTOM DIARY V2.1 USING DATA FROM A PHASE 2 STUDY IN PATIENTS WITH MODERATE TO SEVERE CELIAC DISEASE (UEGW 2025) - "Aims & This psychometric analysis of the CDSD v2.1 was conducted using data from a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical study (NCT5353985)2 assessing the efficacy and safety of zamaglutenase (TAK-062) in patients with moderate to severe CeD (N = 153)... The results from this study support the CDSD v2.1 as a reliable, valid and responsive measure and provide psychometric evidence for constructing clinical study endpoints based on change in average GI symptom severity or %SFD GI domain scores in patients with moderate to severe CeD."

Clinical • P2 data • Celiac Disease • Immunology

Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments. (PubMed, Nutrients) - "These include gluten-degrading enzymes (e.g., AN-PEP, Latiglutenase, Zamaglutenase), gluten-sequestering agents (e.g., AGY-010, BL-7010), modulators of intestinal permeability (e.g., Larazotide acetate, IMU-856), immune-modulating agents (e.g., ZED1227, AMG 714, EQ102), and strategies for immune tolerization (e.g., TAK-101, KAN-101, Nexvax2). Continued research is essential to validate efficacy, optimize dosing, and ensure safety in broader patient populations. Here, we provide a comprehensive overview of the therapeutic landscape for CeD, analyze the main strengths and limitations of each treatment and highlight promising directions for future management of CeD, altogether evidencing the urgent need to develop effective alternatives for these patients."

Journal • Review • Allergy • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | N=357 ➔ 153 | Trial completion date: May 2025 ➔ Nov 2024 | Trial primary completion date: May 2025 ➔ Nov 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=357 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=350 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology

This clinical research study of TAK-062 (the "Takeda study drug") is for subjects with celiac disease with ongoing symptoms believed to be related to gluten exposure. They will be randomly assigned to the group receiving either placebo or the study drug. Placebo looks like the study drug but does not contain any active medicine. Subjects should follow normal gluten-free diet throughout t (clinicaltrialsregister.eu) - P2 | N=350 | Sponsor: Takeda

New P2 trial • Celiac Disease • Gastrointestinal Disorder • Immunology

"KumaMax: An enzyme designed to treat Celiac disease, now in clinical trials. @Ingrid_Pultz, @pvpbio, @TakedaPharma" (@UWproteindesign)

Clinical • Celiac Disease • Immunology

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (clinicaltrials.gov) - P2 | N=350 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Celiac Disease • Immunology

A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease (clinicaltrials.gov) - P1 | N=119 | Completed | Sponsor: Millennium Pharmaceuticals, Inc. | Trial completion date: Mar 2021 ➔ Jul 2021

Trial completion date • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology

A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease (clinicaltrials.gov) - P1; N=119; Completed; Sponsor: Millennium Pharmaceuticals, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology

Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease. (PubMed, Gastroenterology) - "TAK-062 is well tolerated, and rapidly and effectively degrades large amounts of gluten, supporting the development of this novel enzyme as an oral therapeutic for patients with CeD."

Clinical • Journal • PK/PD data • Celiac Disease • Immunology

KUMA062 EFFECTIVELY DIGESTS GLUTEN IN THE HUMAN STOMACH: RESULTS OF A PHASE 1 STUDY (DDW 2020) - "Kuma062 can degrade ≥95.5% (95% confidence interval 92.6–98.3%) of immunogenic gliadin fractions in the human stomach in physiologically relevant timeframes on or off PPI, suggesting that it may be a promising oral therapeutic for CD. Further studies are warranted."

P1 data • Celiac Disease • Immunology