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- amelenodor (NX-13) / Landos Biopharma
ROLE OF NLRX1 AGONIST NX-13 IN REDUCING VISCERAL HYPERSENSITIVITY IN PRECLINICAL GASTROINTESTINAL INFLAMMATION (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_7344;
Adequate management of persistent pain in IBD patients with or without active bowel inflammation remains an unmet need in the treatment of IBD. The potential for NX-13 to specifically reduce visceral hypersensitivity and abdominal pain will be evaluated further in the ongoing phase 2 human NEXUS trial in patients with UC.
- amelenodor (NX-13) / Landos Biopharma, LABP-73 / Landos Biopharma
THE EFFECT OF NLRX1 ACTIVATION ON EOSINOPHILS IN ULCERATIVE COLITIS AND INFLAMMATION: TRANSLATIONAL LEARNINGS ACROSS DISEASES AND FROM MOUSE TO HUMAN (101 - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_2637;
Neutrophil and eosinophil infiltration were reduced in UC patients treated with the gut selective NLRX1 agonist, NX-13, and was coupled with better clinical outcomes. The effect of NX-13 on eosinophils will be evaluated further in the ongoing phase 2 NEXUS trial in patients with UC.
- amelenodor (NX-13) / Landos Biopharma
The Effect of NLRX1 Activation on Eosinophils in Ulcerative Colitis and Inflammation: Translational Learnings Across Diseases and from Mouse to Human (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1647;
Studies of NLRX1 agonists (gut-selective NX-13 & systemic LABP-73) in diverse disease models identified novel cellular targets of NLRX1 activation...2 L Peyrin-Biroulet, et al. JCC (17) Supp
- amelenodor (NX-13) / Landos Biopharma
Role of NLRX1 Agonist NX-13 in Reducing Visceral Hypersensitivity in Preclinical Gastrointestinal Inflammation (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1346;
JCC (14)Supp 4 Wils et al. J Clin Med 11(15)
- amelenodor (NX-13) / Landos Biopharma
The Immunometabolic Bimodal Mechanism of NLRX1 Agonist NX-13 in a Pig Model of Ulcerative Colitis (Poster exhibition) - Jan 25, 2024 - Abstract #ECCOIBD2024ECCO_IBD_1319;
These results align with previous murine results and observations in the phase 1b clinical program. Therefore, they can be used to generate additional mechanistic hypotheses for translational studies in the ongoing NEXUS phase 2 trial in moderate to severe UC.
- amelenodor (NX-13) / Landos Biopharma
Translating Pharmacokinetic and Efficacy Outcomes of NLRX1 Agonist NX-13: Contrasting a Pig Model and a Human Phase 1b Clinical Trial in Ulcerative Colitis (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_814;
2 Peyrin-Biroulet, et al. JCC (17) Supp.
- LABP-69 / Landos Biopharma, amelenodor (NX-13) / Landos Biopharma
Modulation of Immunometabolism via NLRX1 or PLXDC2: Novel Bimodal Mechanisms for the Treatment of Inflammatory Bowel Diseases (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_691;
Results NX-13, a novel NLRX1 agonist, resulted in regulation of cellular metabolism: activation of mitochondrial genes such as mt - nd3 & odgh , and concomitant down-regulation of glucose uptake by murine T cells (Fig1A)...LABP-69 also reduced superoxide levels in BMDM...J Immunol 203(12) 3 Tubau-Juni et al. J Immunol 206(Supp)
- NX-13 / Landos Biopharma, LianBio
Rapid Symptomatic Relief Is Correlated with Early Endoscopic Response to the Nucleotide-Binding Oligomerization Domain, Leucine Rich Repeat Containing X1 (Nlrx1) Agonist Nx-13 in Ulcerative Colitis in a Phase 1b Study (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_4117;
P2
No placebo patients achieved Endoscopic Response. More than half of NX-13 dosed patients with Symptom Improvement at week 2 progressed to achieve rapid Endoscopic Response after only 4 weeks, with 26% in complete Endoscopic Remission in this short trial (Table 1).
- NX-13 / Landos Biopharma, LianBio
The Nucleotide-Binding Oligomerization Domain, Leucine Rich Repeat Containing X1 Agonist NX-13 Demonstrates Rapid Symptomatic and Biomarkers Improvement in Ulcerative Colitis: Results in a Phase 1b Study (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_4080;
P2
Early Symptom Improvement in RBS or SFS was observed by NX-13 patients within 48 hours with a clear demarcation after just 2 weeks of treatment, versus placebo (Table 1, Fig1). The greatest response was seen in the 250mg IR group with 9 patients showing Symptom Improvement and 5 in Total Symptomatic Remission at week 2.
- NX-13 / Landos Biopharma, LianBio
Target Engagement and Pharmacodynamic Molecular Mechanism Evaluation in a Phase 1b Study of the Nucleotide-Binding Oligomerization Domain, Leucine Rich Repeat Containing X1 (NLRX1) Agonist NX-13 in Ulcerative Colitis (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_4021;
P2
All NX-13 treated groups showed target engagement through mean positive increases in NLRX1 expression versus placebo at week 4, with more pronounced upregulation observed in responding patients (Fig1A). Placebo patients
- TARGET ENGAGEMENT AND PHARMACODYNAMIC MOLECULAR MECHANISM EVALUATION IN A PHASE 1B STUDY OF THE NUCLEOTIDE-BINDING OLIGOMERIZATION DOMAIN, LEUCINE RICH REPEAT CONTAINING X1 (NLRX1) AGONIST NX-13 IN ULCERATIVE COLITIS (Science Lounge) - Jul 8, 2023 - Abstract #UEGW2023UEGW_1799;
- RAPID SYMPTOMATIC RELIEF IS CORRELATED WITH EARLY ENDOSCOPIC RESPONSE TO THE NUCLEOTIDE-BINDING OLIGOMERIZATION DOMAIN, LEUCINE RICH REPEAT CONTAINING X1 (NLRX1) AGONIST NX-13 IN ULCERATIVE COLITIS: RESULTS IN A PHASE 1B STUDY (A3) - Jul 8, 2023 - Abstract #UEGW2023UEGW_893;
- THE NUCLEOTIDE-BINDING OLIGOMERIZATION DOMAIN, LEUCINE RICH REPEAT CONTAINING X1 (NLRX1) AGONIST NX-13 DEMONSTRATES RAPID SYMPTOMATIC AND BIOMARKERS IMPROVEMENT IN ULCERATIVE COLITIS: RESULTS IN A PHASE 1B STUDY (A3) - Jul 8, 2023 - Abstract #UEGW2023UEGW_736;
- ||| amelenodor (ABBV-113) / AbbVie
Enrollment open: Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - May 8, 2023
P2, N=80, Recruiting, Sponsor: Landos Biopharma Inc.
Placebo patients Not yet recruiting --> Recruiting
- || amelenodor (ABBV-113) / AbbVie
Trial completion date, Trial primary completion date: Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Mar 30, 2023
P2, N=80, Not yet recruiting, Sponsor: Landos Biopharma Inc.
Not yet recruiting --> Recruiting Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025
- |||| amelenodor (ABBV-113) / AbbVie
New P2 trial: Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Mar 27, 2023
P2, N=80, Not yet recruiting, Sponsor: Landos Biopharma Inc.
- NX-13 / Landos Biopharma, LianBio
A PHASE 1B STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND CLINICAL EFFICACY OF THE NUCLEOTIDE-BINDING OLIGOMERIZATION DOMAIN, LEUCINE RICH REPEAT CONTAINING X1 (NLRX1) AGONIST NX-13 IN ULCERATIVE COLITIS (South Hall A, Poster Hall - McCormick Place) - Mar 23, 2023 - Abstract #DDW2023DDW_6273;
Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025 Biologic exposed patients, stable 5
- NX-13 / Landos Biopharma, LianBio
A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of the Nucleotide-binding oligomerization domain, Leucine rich Repeat containing X1 (NLRX1) agonist NX-13 in Ulcerative Colitis (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_1376;
The exploratory efficacy endpoints indicated rapid clinical, endoscopic, and histologic improvement at week 4, relative to placebo. This novel mechanism of action will be further evaluated in a phase 2 study.
- || amelenodor (ABBV-113) / AbbVie
Trial completion: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Jan 9, 2023
P1, N=39, Completed, Sponsor: Landos Biopharma Inc.
This novel mechanism of action will be further evaluated in a phase 2 study. Active, not recruiting --> Completed
- | amelenodor (ABBV-113) / AbbVie
Trial completion date: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Sep 7, 2022
P1, N=40, Active, not recruiting, Sponsor: Landos Biopharma Inc.
Active, not recruiting --> Completed Trial completion date: Jul 2022 --> Oct 2022
- || amelenodor (ABBV-113) / AbbVie
Enrollment closed: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Mar 10, 2022
P1, N=40, Active, not recruiting, Sponsor: Landos Biopharma Inc.
Trial completion date: Jul 2022 --> Oct 2022 Recruiting --> Active, not recruiting
- | amelenodor (ABBV-113) / AbbVie
Trial completion date, Trial primary completion date: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Mar 3, 2022
P1, N=40, Recruiting, Sponsor: Landos Biopharma Inc.
Recruiting --> Active, not recruiting Trial completion date: Feb 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Apr 2022
- || NX-13 / Landos Biopharma, LianBio
PK/PD data, Preclinical, Journal: Exploratory studies with NX-13: oral toxicity and pharmacokinetics in rodents of an orally active, gut-restricted first-in-class therapeutic for IBD that targets NLRX1. (Pubmed Central) - Feb 3, 2022
Analysis of colon tissue after oral dosing with 1 and 10 mg/kg indicated high peak concentrations (10 and 100 µg/g, respectively) that scale in a dose-proportional manner. These experiments suggest that NX-13 is safe and well-tolerated in rats given oral doses as high as 1000 mg/kg with a favorable gastrointestinal localized pharmacokinetic profile, confirming NX-13 as a promising therapeutic for Crohn's disease and ulcerative colitis.
- | amelenodor (ABBV-113) / AbbVie
Trial completion date, Trial primary completion date: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Nov 2, 2021
P1, N=40, Recruiting, Sponsor: Landos Biopharma Inc.
These experiments suggest that NX-13 is safe and well-tolerated in rats given oral doses as high as 1000 mg/kg with a favorable gastrointestinal localized pharmacokinetic profile, confirming NX-13 as a promising therapeutic for Crohn's disease and ulcerative colitis. Trial completion date: Oct 2021 --> Feb 2022 | Trial primary completion date: Oct 2021 --> Jan 2022
- NX-13 / Landos Biopharma
[VIRTUAL] SAFETY, TOLERABILITY AND PHARMACOKINETICS OF NX-13 IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 1 STUDY IN NORMAL HEALTHY VOLUNTEERS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_4578;
NX-13 is safe and well-tolerated with a wide therapeutic margin above anticipated therapeutic doses in healthy volunteers. A Phase Ib study in UC for NX-13 was initiated in 2021.
- NX-13 / Landos Biopharma
[VIRTUAL] SAFETY, TOLERABILITY AND PHARMACOKINETICS OF NX-13 IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 1 STUDY IN NORMAL HEALTHY VOLUNTEERS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_2398;
NX-13 is safe and well-tolerated with a wide therapeutic margin above anticipated therapeutic doses in healthy volunteers. A Phase Ib study in UC for NX-13 was initiated in 2021.
- NX-13 / Landos Biopharma
[VIRTUAL] SAFETY, TOLERABILITY AND PHARMACOKINETICS OF NX-13 IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 1 STUDY IN NORMAL HEALTHY VOLUNTEERS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_567;
NX-13 is safe and well-tolerated with a wide therapeutic margin above anticipated therapeutic doses in healthy volunteers. A Phase Ib study in UC for NX-13 was initiated in 2021.
- || amelenodor (ABBV-113) / AbbVie
Enrollment open: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Jun 29, 2021
P1, N=40, Recruiting, Sponsor: Landos Biopharma Inc.
A Phase Ib study in UC for NX-13 was initiated in 2021. Not yet recruiting --> Recruiting
- || amelenodor (ABBV-113) / AbbVie
New P1 trial: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis (clinicaltrials.gov) - Apr 27, 2021
P1, N=40, Not yet recruiting, Sponsor: Landos Biopharma Inc.
- ||| amelenodor (ABBV-113) / AbbVie
Trial completion: Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers (clinicaltrials.gov) - Jan 28, 2021
P1, N=56, Completed, Sponsor: Landos Biopharma Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || amelenodor (ABBV-113) / AbbVie
Enrollment closed: Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers (clinicaltrials.gov) - Oct 7, 2020
P1, N=56, Active, not recruiting, Sponsor: Landos Biopharma Inc.
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting
- ||| amelenodor (ABBV-113) / AbbVie
New P1 trial: Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers (clinicaltrials.gov) - Jul 6, 2020
P1, N=56, Not yet recruiting, Sponsor: Landos Biopharma Inc.