- |||||||||| latiglutenase (IMGX003) / Entero Therap
Efficacy and Safety of Latiglutinase In Celiac Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_5434;
No significant difference was observed between latiglutenase and placebo in the villus height to crypt depth ratio (MD: 0.05, 95% CI [-0.41, 0.51], P = 0.82) (Figure 1-A) or intraepithelial lymphocyte densities (MD: -11.82, 95% CI [-28.41, 4.78], P = 0.16) (Figure 1-B). Additionally, there were no significant differences in overall AEs (RR: 0.99, 95% CI [0.81, 1.21], P = 0.90), medication-related AEs (RR: 1.33, 95% CI [0.71, 2.49], P = 0.37), or gastrointestinal-related AEs (RR: 1.05, 95% CI [0.82, 1.34], P = 0.70) (Figure 1-C).
- |||||||||| latiglutenase (IMGX003) / Entero Therap
Enrollment change, Trial termination: Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients (clinicaltrials.gov) - Aug 2, 2024
P2, N=84, Terminated,
Additionally, there were no significant differences in overall AEs (RR: 0.99, 95% CI [0.81, 1.21], P = 0.90), medication-related AEs (RR: 1.33, 95% CI [0.71, 2.49], P = 0.37), or gastrointestinal-related AEs (RR: 1.05, 95% CI [0.82, 1.34], P = 0.70) (Figure 1-C). N=120 --> 84 | Active, not recruiting --> Terminated; Due to low enrollment related to Covid.
- |||||||||| TAK-227 / Takeda, latiglutenase (IMGX003) / Immunogenics
Review, Journal: Celiac disease: Hope for new treatments beyond a gluten-free diet. (Pubmed Central) - Apr 23, 2024
Despite significant efforts, no treatment has yet completed a phase III clinical trial. Future studies will likely focus on the use of supplemental drugs in conjunction to a GFD, with ALV003 and ZED-1227 currently being the most promising therapeutic options.
- |||||||||| latiglutenase (IMGX003) / Immunogenics
A COMPOSITE MUCOSAL SCALE FOR CELIAC DISEASE ENCOMPASSING BOTH MORPHOLOGY AND INFLAMMATION (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3056;
P2, P2a, P
For the gluten-challenge IMGX003-NCCIH-1721 (NCT03585478) trial, we observed an effect size and p-value (ANCOVA) of 0.76, 0.057 for ?Vh:Cd, 0.98, 0.018 for ?IEL and 1.14, 0.007 for ?VCIEL (Figure 1)...[2] Oberhuber G. Histopathology of celiac disease. Biomed Pharmacother 2000; 54:368
- |||||||||| latiglutenase (IMGX003) / Immunogenics
DYNAMICS OF SEROLOGIC CHANGE TO GLUTEN IN CELIAC DISEASE PATIENTS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3043;
P2
Method The test results reported here are from two recent celiac disease trials, IMGX003-NCCIH-1721 (NCT03585478) and IMGX003-NIAID-1821 (NCT04243551)...An expanded view (Figure 2B) shows the linear correlation near the ULN region along with the ULN thresholds for each assay. There is a strong correlation by both measurements as evidenced by a Pearson coefficient R = 0.8584.
- |||||||||| latiglutenase (IMGX003) / Entero Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study of Latiglutenase in T1D/CD Patients (clinicaltrials.gov) - Jul 20, 2023
P2, N=13, Terminated,
There is a strong correlation by both measurements as evidenced by a Pearson coefficient R = 0.8584. N=40 --> 13 | Trial completion date: Jun 2024 --> Dec 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Dec 2022; Covid-19 interruptions and enrollment challenges
- |||||||||| latiglutenase (IMGX003) / Entero Therap
Enrollment closed, Trial completion date, Trial primary completion date: Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients (clinicaltrials.gov) - Jul 20, 2023
P2, N=120, Active, not recruiting,
N=40 --> 13 | Trial completion date: Jun 2024 --> Dec 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Dec 2022; Covid-19 interruptions and enrollment challenges Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023
- |||||||||| latiglutenase (IMGX003) / Immunogenics
A COMPOSITE QUANTITATIVE HISTOLOGY SCALE BASED ON VH:CD AND IEL (South Hall A, Poster Hall - McCormick Place) - Mar 23, 2023 - Abstract #DDW2023DDW_6612;
P2, P2b
Results Our first example is for our recently completed gluten challenge study (CeliacShield, NCT03585478) using a 1,200 mg dose of latiglutenase...[3] Oberhuber G. Histopathology of celiac disease. Biomed Pharmacother 2000;54:368
- |||||||||| latiglutenase (IMGX003) / Entero Therap
Enrollment change, Trial completion date, Trial primary completion date: Study of Latiglutenase in T1D/CD Patients (clinicaltrials.gov) - Aug 4, 2022
P2, N=40, Recruiting,
gov number NCT03585478. N=30 --> 40 | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Apr 2023 --> Apr 2024
- |||||||||| latiglutenase (IMGX003) / Immunogenics
CELIACSHIELDTM GLUTEN CHALLENGE STUDY – LATIGLUTENASE PROTECTS THE MUCOSA AND ATTENUATES SYMPTOMS OF CELIAC DISEASE (27 - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_6643;
P2
Measurements of GIPs in urine showed reduction of gluten of >90% for latiglutenase vs. placebo. Serology measurements for TTG-IgA, DGP-IgG and DGP-IgG all showed worsening for placebo and improvement for latiglutenase groups relative to baseline.We further acknowledge the valuable contributions of Ana Ramos, Vasiliy Loskutov, Irina Horwath, and Isabel Hujoel.
- |||||||||| latiglutenase (IMGX003) / Immunogenics, larazotide (AT1001) / 9 Meters Biopharma
Review, Journal: Current pharmacological approaches and potential future therapies for Celiac disease. (Pubmed Central) - Jan 27, 2022
AT-1001 aims to close the villi's tight junctions, while IMGX-003 acts as a gluten endopeptidase that degrades gluten before being absorbed in the small intestine. This review article summarizes the various preclinical research and clinical trials being conducted and specifies the mechanism by which these drugs function.
- |||||||||| latiglutenase (IMGX003) / Immunogenics
[VIRTUAL] CELIACSHIELDTM GLUTEN-CHALLENGE STUDY – LATIGLUTENASE PROTECTS THE MUCOSA AND ATTENUATES SYMPTOMS IN CELIAC DISEASE PATIENTS (TV Studio) - Oct 4, 2021 - Abstract #UEGW2021UEGW_5977;
P2
By measuring changes in histology, serology, commonly reported symptoms and GIPs in urine, data confirm the correlation of various biological signatures and successfully support endpoints to clinical support endpoints to clinical outcome measures of attenuation of CeD-related symptoms while maintaining a histologic architecture. Latiglutenase is an orally administered therapeutic drug candidate for the treatment of CeD in patients who follow and maintain a strict gluten-free diet.
- |||||||||| latiglutenase (IMGX003) / Entero Therap
Enrollment change, Trial initiation date: Study of Latiglutenase in T1D/CD Patients (clinicaltrials.gov) - Sep 26, 2021
P2, N=30, Recruiting,
Latiglutenase is an orally administered therapeutic drug candidate for the treatment of CeD in patients who follow and maintain a strict gluten-free diet. N=200 --> 30 | Initiation date: Apr 2021 --> Oct 2021
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Trial primary completion date: Latiglutenase as a Treatment for Celiac Disease (clinicaltrials.gov) - Sep 26, 2021
P2, N=79, Completed,
N=200 --> 30 | Initiation date: Apr 2021 --> Oct 2021 Trial primary completion date: Jan 2020 --> Jan 2021
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Journal: Rationally engineered prolyl endopeptidases from Sphingomonas capsulata with improved hydrolytic activity towards pathogenic peptides of celiac diseases. (Pubmed Central) - Apr 2, 2021
A combination of prolyl endopeptidase from Sphingomonas capsulata (SC PEP) and a glutamine-specific endoprotease (EP-B2 from barley) known as latiglutenase showed insufficient benefits in phase II clinical trials, likely because of its low enzyme activity in the gastric environment...We have investigated the mechanism underlying the enhanced activity of these mutants, and found that a conformational transition of the β-propeller domain and catalytic domain of SC PEP was important for enzyme activity, and this transition was affected by residues in the catalytic domain and at the domain interface; a shorter distance between the substrate Pro and the oxyanion holes was also crucial for improving SC PEP catalytic activity. Our results provide useful information for the rational design of highly active SC PEPs to accelerate the development of enzyme therapeutics candidates for Celiac disease.
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Trial completion: Latiglutenase as a Treatment for Celiac Disease (clinicaltrials.gov) - Jan 29, 2021
P2, N=79, Completed,
Our results provide useful information for the rational design of highly active SC PEPs to accelerate the development of enzyme therapeutics candidates for Celiac disease. Recruiting --> Completed
- |||||||||| latiglutenase (IMGX003) / Immunogenics, larazotide (AT1001) / 9 Meters Biopharma
Review, Journal: Therapeutic options for coeliac disease: What else beyond gluten-free diet? (Pubmed Central) - Dec 18, 2020
Most developing therapies are only in the pre-clinical phase with only a few being tested in phase 2b or 3 trials. Although new approaches raise the hope for coeliacs giving them a chance to come back to gluten, for the time being a cautionary appraisal of new therapies suggests that they may have a complementary role to gluten withdrawal, mainly to prevent inadvertent gluten contamination.
- |||||||||| latiglutenase (IMGX003) / Entero Therap
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients (clinicaltrials.gov) - Dec 16, 2020
P2, N=120, Recruiting,
Although new approaches raise the hope for coeliacs giving them a chance to come back to gluten, for the time being a cautionary appraisal of new therapies suggests that they may have a complementary role to gluten withdrawal, mainly to prevent inadvertent gluten contamination. Trial completion date: Aug 2021 --> Feb 2022 | Initiation date: Aug 2020 --> Nov 2020 | Trial primary completion date: Jun 2021 --> Dec 2021 | Not yet recruiting --> Recruiting
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Journal: Update on celiac disease. (Pubmed Central) - Aug 26, 2020
Current therapeutic trials offer promising nondietary treatment for celiac patients. The development of an animal model can provide a better understanding of the pathogenesis of celiac disease.
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Trial completion date, Trial primary completion date: Latiglutenase as a Treatment for Celiac Disease (clinicaltrials.gov) - Aug 8, 2020
P2, N=80, Recruiting,
The development of an animal model can provide a better understanding of the pathogenesis of celiac disease. Trial completion date: May 2020 --> Dec 2020 | Trial primary completion date: Feb 2020 --> Sep 2020
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Review, Journal: Novel non-dietary therapies for celiac disease. (Pubmed Central) - Jul 21, 2020
We used keywords including, but not limited to, "celiac disease," "non-dietary," "therapeutics," "pathophysiology," "Endopeptidases," "tight junction modulators," "vaccine," and "Nexvax2". We focused mainly on articles that conducted pathophysiologic and therapeutic research in human trials.
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Enrollment open: Latiglutenase as a Treatment for Celiac Disease (clinicaltrials.gov) - Mar 4, 2019
P2, N=80, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| latiglutenase (IMGX003) / Immunogenics
Trial initiation date: Latiglutenase as a Treatment for Celiac Disease (clinicaltrials.gov) - Feb 11, 2019
P2, N=80, Not yet recruiting,
Not yet recruiting --> Recruiting Initiation date: Jul 2018 --> Mar 2019
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