- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: AT1001 for the Treatment of COVID-19 Related MIS-C (clinicaltrials.gov) - Jun 12, 2024
P2, N=12, Terminated,
A deeper understanding of the complex interplay among zonulin, intestinal permeability, and CIDs is crucial, paving the way for novel therapeutic strategies and personalized approaches to patient care. N=20 --> 12 | Trial completion date: Dec 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> May 2024; Decline in MISC cases
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Phase classification, Trial completion date, Trial primary completion date: AT1001 for the Treatment of COVID-19 Related MIS-C (clinicaltrials.gov) - Mar 6, 2024
P2, N=20, Recruiting,
N=20 --> 12 | Trial completion date: Dec 2025 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> May 2024; Decline in MISC cases Phase classification: P2a --> P2 | Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Sep 2022 --> Jun 2025
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Phase classification: AT1001 for the Treatment of Long COVID (clinicaltrials.gov) - Mar 6, 2024
P2, N=48, Recruiting,
Phase classification: P2a --> P2 | Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Sep 2022 --> Jun 2025 Phase classification: P2a --> P2
- |||||||||| NM-136 / 9 Meters Biopharma, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Efficacy, safety, and treatment durability of intravenous immunoglobulin in autoimmune blistering diseases (e-Poster Hall) - Aug 30, 2023 - Abstract #EADV2023EADV_2726;
IVIg has no major influence on the normal immune system, which makes its utilization for patients with AIBDs reasonable. Table 1** Demographic data, efficacy, and treatment durability of intravenous immunoglobulin in patients with bullous diseases Pemphigus#Bullous pemphigoid Mucous membrane pemphigoid Epidermolysis bullousa IVIg RTX+IVIg IVIg RTX+IVIg Patients 410 90 70 12 Clinical response, n (%) Yes 290 (90.9%) 61 (100%) 33 (80.5%) No 29 (9.1%) 0 (0.0%) 8 (19.5%) NM 91 29 29 Time to clinical response, m Mean 1.9 2.6 2.8 Range 0.3-7.5 0.4-6 2-4 NM 236 33 52 Clinical remission, n (%) Yes 227 (82.8%) 78 (86.7 %) 22 (88.0%) No 47 (17.2%) 12 (13.3%) 3 (12.0%) NM 136 0 45 Treatment durability Relapse, n (%) 41 (44.6%) 22 (40.8%) 10 (52.6%) Follow-up, m 37.2 67.8 22.7 NM 312 27 50 IVIg, intravenous immunoglobulin; RTX, rituximab; NM, not mentioned.
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Enrollment open: AT1001 for the Treatment of Long COVID (clinicaltrials.gov) - Jun 22, 2023
P2a, N=48, Recruiting,
Table 1** Demographic data, efficacy, and treatment durability of intravenous immunoglobulin in patients with bullous diseases Pemphigus#Bullous pemphigoid Mucous membrane pemphigoid Epidermolysis bullousa IVIg RTX+IVIg IVIg RTX+IVIg Patients 410 90 70 12 Clinical response, n (%) Yes 290 (90.9%) 61 (100%) 33 (80.5%) No 29 (9.1%) 0 (0.0%) 8 (19.5%) NM 91 29 29 Time to clinical response, m Mean 1.9 2.6 2.8 Range 0.3-7.5 0.4-6 2-4 NM 236 33 52 Clinical remission, n (%) Yes 227 (82.8%) 78 (86.7 %) 22 (88.0%) No 47 (17.2%) 12 (13.3%) 3 (12.0%) NM 136 0 45 Treatment durability Relapse, n (%) 41 (44.6%) 22 (40.8%) 10 (52.6%) Follow-up, m 37.2 67.8 22.7 NM 312 27 50 IVIg, intravenous immunoglobulin; RTX, rituximab; NM, not mentioned. Not yet recruiting --> Recruiting
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Review, Journal: Zonulin as a Potential Therapeutic Target in Microbiota-Gut-Brain Axis Disorders: Encouraging Results and Emerging Questions. (Pubmed Central) - May 2, 2023
In addition to focusing on the effect of microbiome on intestinal zonulin release, we also summarize potential pharmaceutical approaches to modulate zonulin-associated pathways with larazotide acetate and other zonulin receptor agonists or antagonists. The present review also addresses the emerging issues, including the use of misleading nomenclature or the unsolved questions about the exact protein sequence of zonulin.
- |||||||||| vurolenatide (NM-002) / 9 Meters Biopharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome. (clinicaltrials.gov) - Dec 20, 2022
P2, N=12, Terminated,
The present review also addresses the emerging issues, including the use of misleading nomenclature or the unsolved questions about the exact protein sequence of zonulin. N=22 --> 12 | Trial completion date: Dec 2021 --> Aug 2022 | Recruiting --> Terminated | Trial primary completion date: Oct 2021 --> Aug 2022; Trial terminated by Sponsor
- |||||||||| RDD1609 / 9 Meters Biopharma
Enrollment change, Trial withdrawal: RDD1609 as a Treatment for Idiopathic Pruritus Ani (clinicaltrials.gov) - Nov 3, 2022
P2, N=0, Withdrawn,
N=22 --> 12 | Trial completion date: Dec 2021 --> Aug 2022 | Recruiting --> Terminated | Trial primary completion date: Oct 2021 --> Aug 2022; Trial terminated by Sponsor N=24 --> 0 | Unknown status --> Withdrawn
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms (clinicaltrials.gov) - Jul 26, 2022
P3, N=307, Terminated,
Taken together, these studies document a pathway by which RG strains from Lupus patients contribute to a leaky gut and features of autoimmunity implicated in the pathogenesis of flares of clinical Lupus disease. N=630 --> 307 | Trial completion date: Dec 2021 --> Jul 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2021 --> Jul 2022; Trial terminated by Sponsor
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Modulation of the Intestinal Tight Junction Reduces Lung Fibrosis in an Animal Model for Idiopathic Pulmonary Fibrosis: The Role of Intestinal Microbiome Gut-Lung Axis in Idiopathic Pulmonary Fibrosis (Area K, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_5007;
On the following 20 days, mice were administered once daily with larazotide orally (1 mg/kg), larazotide intratracheally (25 μg/mouse), vehicle (control) or dexamethasone (0.25 mg/kg, active control)...Conclusions - In an animal model for IPF, the tight-junction modulator larazotide administered orally reduced pulmonary fibrosis better than administered intratracheally, indicating that the gut microbiome may play an important role in pulmonary fibrosis. Therefore, intestinal tight junction modulators, such as larazotide, may have a role in the treatment of IPF via gut-lung axis.
- |||||||||| 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.
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Enrollment open: AT1001 for the Treatment of COVID-19 Related MIS-C (clinicaltrials.gov) - Oct 10, 2021
P2a, N=20, Recruiting,
This review article summarizes the various preclinical research and clinical trials being conducted and specifies the mechanism by which these drugs function. Not yet recruiting --> Recruiting
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Journal: Larazotide Acetate: A Pharmacological Peptide Approach to Tight Junction Regulation. (Pubmed Central) - Jul 28, 2021
More recently, LA has been linked to inhibition of myosin light chain kinase, which likely reduces tension on actin filaments, thereby facilitating tight junction closure. Small (rodent) and large (porcine) animal studies have been conducted that demonstrate the importance of LA as a tight junction regulatory peptide in conditions other than celiac disease, including collagen-induced arthritis in mice and intestinal ischemic injury in pigs.
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Clinical, Journal: Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier. (Pubmed Central) - Jul 24, 2021
Small (rodent) and large (porcine) animal studies have been conducted that demonstrate the importance of LA as a tight junction regulatory peptide in conditions other than celiac disease, including collagen-induced arthritis in mice and intestinal ischemic injury in pigs. These mechanistic data of MIS-C pathogenesis provide insight into targets for diagnosing, treating, and preventing MIS-C, which are urgently needed for this increasingly common severe COVID-19-related disease in children.
- |||||||||| Acomplia (rimonabant) / Sanofi, larazotide (AT1001) / 9 Meters Biopharma, Galafold (migalastat) / Amicus
Preclinical, Journal: Neuronal nicotinic acetylcholine receptors mediate ∆ -THC dependence: Mouse and human studies. (Pubmed Central) - Feb 11, 2021
Finally, the human genetic association studies indicated that variations in the genes that code for the α5, α3, β4, and α6 nAChRs were associated with cannabis disorder phenotypes. Overall, these findings suggest that α3β4* and α6β4* nAChR subtypes represent viable targets for the development of medications to counteract THC dependence.
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Journal: In silico Analysis Revealed Potential Anti-SARS-CoV-2 Main Protease Activity by the Zonulin Inhibitor Larazotide Acetate. (Pubmed Central) - Feb 2, 2021
Combined, these studies suggest that AT1001, besides its well-demonstrated effect in ameliorating mucosal permeability in ALI/ARDS, may also exert a direct anti-SARS-CoV-2 effect by blocking the M. AT1001 has been used extensively in a variety of animal models of ALI demonstrating robust safety and efficacy; it is currently in phase 3 trials in celiac subjects showing strong safety and efficacy profiles. We therefore propose its use as a specific anti-SARS-CoV-2 multitargeting treatment for the current pandemic.
- |||||||||| 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.
- |||||||||| vurolenatide (NM-002) / 9 Meters Biopharma
Enrollment closed: Proof of Concept Study in Patients With Short Bowel Syndrome (clinicaltrials.gov) - Nov 20, 2020
P1/2, N=12, Active, not 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. Recruiting --> Active, not recruiting
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma, Galafold (migalastat) / Amicus
Preclinical, Journal: Near-infrared spectroscopy as a tool for in vivo analysis of human muscles. (Pubmed Central) - Oct 22, 2020
In addition to the non-invasive detection of tissue oxygenation, NIR spectroscopy provided the spectral signatures (ie, "fingerprints") of upper limb flexors and extensors, which represent specific, accurate, and reproducible measures of the overall biological status of these muscles. Thus, non-invasive NIR spectroscopy enables more thorough evaluation of the muscular system and optimal monitoring of the effectiveness of therapeutic or rehabilitative interventions.
- |||||||||| larazotide (AT1001) / 9 Meters Biopharma
Journal: Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis. (Pubmed Central) - Aug 11, 2020
Moreover, treatment with the zonulin antagonist larazotide acetate, which specifically increases intestinal barrier integrity, effectively reduces arthritis onset. These data identify a preventive approach for the onset of autoimmune disease by specifically targeting impaired intestinal barrier function.
- |||||||||| vurolenatide (NM-002) / 9 Meters Biopharma
Enrollment open: Proof of Concept Study in Patients With Short Bowel Syndrome (clinicaltrials.gov) - Jul 16, 2020
P1/2, N=12, Recruiting,
These data identify a preventive approach for the onset of autoimmune disease by specifically targeting impaired intestinal barrier function. Not yet recruiting --> Recruiting
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