A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study With Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants w/ Moderate to Severe Ulcerative Colitis

Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

Start Date24 Apr 2023

Sponsor / Collaborator

AbbVie, Inc.

NCT04862741

/ CompletedPhase 1

A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

Start Date05 May 2021

Sponsor / Collaborator

Landos Biopharma, Inc.

NCT04458805

/ CompletedPhase 1

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.

Start Date10 Jul 2020

Sponsor / Collaborator

Landos Biopharma, Inc.

100 Clinical Results associated with Amelenodor

100 Translational Medicine associated with Amelenodor

100 Patents (Medical) associated with Amelenodor

Literatures (Medical) associated with Amelenodor

01 Dec 2024·Computational and Structural Biotechnology Journal

Insights into the structure of NLR family member X1: Paving the way for innovative drug discovery

Article

Author: Ascher, David B. ; Jewell, Shannon ; Nguyen, Thanh Binh ; Robertson, Avril A.B.

Nucleotide-binding oligomerization domain, leucine rich repeat containing X1 (NLRX1) is a negative regulator of the nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) pathway, with a significant role in the context of inflammation. Altered expression of NLRX1 is prevalent in inflammatory diseases leading to interest in NLRX1 as a drug target. There is a lack of structural information available for NLRX1 as only the leucine-rich repeat domain of NLRX1 has been crystallised. This lack of structural data limits progress in understanding function and potential druggability of NLRX1. We have modelled full-length NLRX1 by combining experimental, homology modelled and AlphaFold2 structures. The full-length model of NLRX1 was used to explore protein dynamics, mutational tolerance and potential functions. We identified a new RNA binding site in the previously uncharacterized N-terminus, which served as a basis to model protein-RNA complexes. The structure of the adenosine triphosphate (ATP) binding domain revealed a potential catalytic functionality for the protein as a member of the ATPase Associated with Diverse Cellular Activity family of proteins. Finally, we investigated the interactions of NLRX1 with small molecule activators in development, revealing a binding site that has not previously been discussed in literature. The model generated here will help to catalyse efforts towards creating new drug molecules to target NLRX1 and may be used to inform further studies on functionality of NLRX1.

31 May 2024·Journal of Crohn's & colitis

The Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study

Article

Author: Cataldi, Fabio ; Danese, Silvio ; Schreiber, Stefan ; Verstockt, Bram ; Siegmund, Britta ; Mosig, Rebecca ; Feagan, Brian G ; Rieder, Florian ; Yarur, Andres ; Colombel, Jean-Frederic ; Vermeire, Severine ; Dubinsky, Marla ; Peyrin-Biroulet, Laurent ; Lichtiger, Simon ; Panaccione, Remo

Abstract:

Background and Aims:

NX-13 activation of NLRX1 reduces intracellular reactive oxygen species and decreases inflammation in animal models of colitis. A phase 1a trial demonstrated a gut-selective pharmacokinetic profile with good tolerability. This phase Ib study aimed to evaluate the safety, tolerability, and pharmacokinetics of NX-13 in patients with active ulcerative colitis [UC].

Methods:

We conducted a multicentre, randomized, double-blind, placebo-controlled trial of NX-13 in patients with active UC. Patients with a Mayo Clinic Score of 4–10 were randomly assigned [3:3:3:1 ratio] to three NX-13 oral dose groups (250 mg immediate release [IR], 500 mg IR, or 500 mg delayed release [DR], or placebo) once daily for 4 weeks. Safety and pharmacokinetics were the primary and secondary objectives, respectively.

Results:

Thirty-eight patients [11 females] were recruited and randomized to placebo [five], NX-13 250 mg IR [11], NX-13 500 mg IR [11], or NX-13 500 mg DR [11] and received at least one dose. There were no serious adverse events or deaths during the trial. One patient [500 mg DR, 1/11] withdrew due to worsening of UC and a second [500 mg IR, 1/11] on the last day of treatment after a panic attack associated with atrial fibrillation. In the efficacy population [36 patients], clinical improvement in rectal bleeding and stool frequency scores relative to placebo were seen as early as week 2 and endoscopic response was seen at week 4.

Conclusions:

NX-13 was generally safe and well tolerated with early signs of rapid symptom and endoscopic improvement. This novel mechanism of action warrants further investigation. ClinicalTrials.gov: NCT04862741.

02 Apr 2024·Autophagy

The NLRX1-SLC39A7 complex orchestrates mitochondrial dynamics and mitophagy to rejuvenate intervertebral disc by modulating mitochondrial Zn ²⁺ trafficking

Article

Author: Zhang, Yukun ; Tong, Bide ; Liang, Huaizhen ; Li, Shuai ; Wu, Xinghuo ; Song, Yu ; Li, Gaocai ; Gao, Yong ; Zhu, Dingchao ; Feng, Xiaobo ; Ma, Liang ; Wang, Kun ; Zhang, Weifeng ; Yang, Cao

Intervertebral disc degeneration (IDD) is the most critical pathological factor in the development of low back pain. The maintenance of nucleus pulposus (NP) cell and intervertebral disc integrity benefits largely from well-controlled mitochondrial quality, surveilled by mitochondrial dynamics (fission and fusion) and mitophagy, but the outcome is cellular context-dependent that remain to be clarified. Our studies revealed that the loss of NLRX1 is correlated with NP cell senescence and IDD progression, which involve disordered mitochondrial quality. Further using animal and in vitro tissue and cell models, we demonstrated that NLRX1 could facilitate mitochondrial quality by coupling mitochondrial dynamic factors (p-DNM1L, L-OPA1:S-OPA1, OMA1) and mitophagy activity. Conversely, mitochondrial collapse occurred in NLRX1-defective NP cells and switched on the compensatory PINK1-PRKN pathway that led to excessive mitophagy and aggressive NP cell senescence. Mechanistically, NLRX1 was originally shown to interact with zinc transporter SLC39A7 and modulate mitochondrial Zn²⁺ trafficking via the formation of an NLRX1-SLC39A7 complex on the mitochondrial membrane of NP cells, subsequently orchestrating mitochondrial dynamics and mitophagy. The restoration of NLRX1 function by gene overexpression or pharmacological agonist (NX-13) treatment showed great potential for regulating mitochondrial fission with synchronous fusion and mitophagy, thus sustaining mitochondrial homeostasis, ameliorating NP cell senescence and rejuvenating intervertebral discs. Collectively, our findings highlight a working model whereby the NLRX1-SLC39A7 complex coupled mitochondrial dynamics and mitophagy activity to surveil and target damaged mitochondria for degradation, which determines the beneficial function of the mitochondrial surveillance system and ultimately rejuvenates intervertebral discs.Abbreviations: 3-MA: 3-methyladenine; Baf-A₁: bafilomycin A₁; CDKN1A/p21: cyclin dependent kinase inhibitor 1A; CDKN2A/p16: cyclin dependent kinase inhibitor 2A; DNM1L/DRP1: dynamin 1 like; EdU: 5-Ethynyl-2'-deoxyuridine; HE: hematoxylin-eosin; IDD: intervertebral disc degeneration; IL1B/IL-1β: interleukin 1 beta; IL6: interleukin 6; MAP1LC3B/LC3B: microtubule associated protein 1 light chain 3 beta; MKI67/Ki67: marker of proliferation Ki-67; LBP: low back pain; MMP: mitochondrial membrane potential; MFN1: mitofusin 1; MFN2: mitofusin 2; MFF: mitochondrial fission factor; NP: nucleus pulposus; NLRX1: NLR family member X1; OMA1: OMA1 zinc metallopeptidase; OPA1: OPA1 mitochondrial dynamin like GTPase; PINK1: PTEN induced kinase 1; PRKN: parkin RBR E3 ubiquitin protein ligase; ROS: reactive oxidative species; SASP: senescence-associated secretory phenotype; SA-GLB1/β-gal: senescence-associated galactosidase beta 1; SO: safranin o; TBHP: tert-butyl hydroperoxide; TP53/p53: tumor protein p53; SLC39A7/ZIP7: solute carrier family 39 member 7; TOMM20: translocase of outer mitochondrial membrane 20; TIMM23: translocase of inner mitochondrial membrane 23.

News (Medical) associated with Amelenodor

02 Jul 2025

·endpoints.news

AbbVie cans oral ulcerative colitis drug from Landos buyout

AbbVie terminated work on the main drug from last year’s $137 million buyout of Landos Biopharma . It’s an abrupt end for ABBV-113, formerly known as NX-13, in ulcerative colitis. AbbVie culled a Phase 2 trial of the drug this week, per the federal trials database. The move was “not safety-related,” the drugmaker said in the trial update. In an emailed statement, an AbbVie spokesperson said the decision was “due to an inadequately differentiated benefit-risk assessment.” The spokesperson declined to say anything about future development “at this time.” The experimental anti-inflammatory drug is an NLRX1 agonist. Activation of NLRX1 is thought to impact “multiple mechanisms” that drive inflammatory bowel disease, AbbVie said at the time of the Landos deal. “This will be a robust Phase 2 with a placebo comparator, and we’ll get objective data from centralized review of endoscopic data,” AbbVie chief scientific officer Roopal Thakkar said in January, according to an AlphaSense transcript of the company’s fourth-quarter earnings call. “If it looks good, [it] definitely would be a Phase 3 asset for us.” The Chicago-area pharma giant bought Landos with the aim of making a first-in-class oral small molecule for the autoimmune condition, as well as studying the drug in other indications, like Crohn’s disease. An oral drug would be a more convenient option for patients. Much of AbbVie’s work in I&I is concentrated on injectable or infused drugs, including the world’s once top-selling medicine Humira, and Skyrizi, initially approved in 2019. It now also markets Rinvoq, an oral medicine approved for multiple inflammatory conditions. AbbVie has staked much of its mid-term future on Skyrizi and Rinvoq, expecting $31 billion in combined sales in 2027 from the two medicines. AbbVie also saw potential in combining ABBV-113 with its other drugs. If ABBV-113 had succeeded, the company planned to test it in combination with Rinvoq, according to Thakkar’s remarks in January. Meanwhile, AbbVie has padded its longer-term autoimmune pipeline with multiple collaborations and two small I&I acquisitions last year for Celsius Therapeutics and Nimble Therapeutics . It’s also working on oral medicines.

AcquisitionDrug ApprovalPhase 2Phase 3

21 Apr 2025

·www.businesswire.com

The NIMML Institute and NImmune Biopharma Showcase How the TITAN-X A.I. Platform has Accelerated Therapeutic Development in the Annual Review of Biomedical Data Science

BLACKSBURG, Va.--(BUSINESS WIRE)--The NIMML Institute, (“NIMML”), a 501 (c)(3) nonprofit research institute dedicated to the discovery of novel precision medicines for infectious and autoimmune diseases, today announced publication of four new case studies in the Annual Review of Biomedical Data Science. Together, they demonstrate how the A.I.-powered TITAN-X Precision Medicine Platform (“TITAN-X”) has been leveraged to identify therapeutic targets and fueled the development of multiple therapeutic program pipelines that have successfully entered clinical testing. In a research collaboration with NImmune Biopharma (“NImmune”), a Phase 3 inflammation and immunology (I&I) private biopharmaceutical company focused on the discovery and development of first-in-class and best-in-class biomarker-driven I&I therapeutics, TITAN-X has been deployed to identify novel therapeutic targets to support the development of late clinical stage biomarker-driven immunoregulatory therapeutics such as omilancor for inflammatory bowel disease (IBD) and NIM-1324 for lupus, rheumatoid arthritis, and a wide range of other I&I indications. TITAN-X also shaped the development of NX-13, which was acquired by Abbvie in March 2024 and is now called ABBV-113, as well as multiple additional novel MoA targets and drug candidates for I&I indications. “These use cases provide several exciting and successful applications of our innovative TITAN-X platform in infectious, inflammatory and autoimmune diseases, highlighting our now clinically proven methods of leveraging large-scale datasets to advance immunological research and drug discovery for I&I,” said Dr. Josep Bassaganya-Riera, Founding Director of NIMML and Founder & CEO of NImmune. “We are very pleased to share how advanced computational systems in biomedicine and drug development can accelerate the development of the next wave of precision medicines. Data-driven and A.I.-powered approaches like the TITAN-X computational platform have already enhanced the pace of drug development, and we are eager to continue leveraging its capabilities to reduce costs, tailor treatments to specific patient populations, and increase the probability of success in clinical trials, starting with NImmune’s LANCL2 therapeutic pipeline.” The article describes how TITAN-X was carefully engineered to rapidly and efficiently integrate large-scale immunology datasets in drug discovery and development. The proprietary platform integrates big data with A.I., bioinformatics, and advanced computational modeling to enable a seamless and cost-effective transition from early target discovery to clinical testing, launch and commercialization of the next wave of first-in-class therapeutics for inflammatory and autoimmune diseases, developing biomarker-driven precision medicines tailored to specific patient populations. Building upon NIMML’s expertise in engineering large-scale computational models of the immune system and its advanced computational tools, TITAN-X is designed to study immunity as a massively and dynamically interacting system that is intimately interconnected with key metabolic processes. Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, TITAN-X can identify transcriptional predictive signatures using its proprietary A.I. algorithms. By analyzing both global gene expression patterns and metabolic profiles while integrating clinical data, TITAN-X can identify responder patterns to facilitate precision medicine approaches for drug development, ensuring that patients receive the best therapies that are most likely to benefit them according to their unique profiles. About the TITAN-X Platform The TITAN-X Precision Medicine Platform combines A.I. methodologies, bioinformatics, and advanced computational modeling to accelerate the development of precision medicines to address the unmet clinical needs of patients with autoimmune diseases. Building upon NIMML’s expertise in engineering large-scale computational models to study immunity as a massively and dynamically interacting system, the TITAN-X Platform integrates each step from new target discovery to enabling biomarker-driven precision clinical drug development. Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, the TITAN-X Platform can identify transcriptional predictive signatures by using its advanced A.I. algorithms. By analyzing gene expression patterns and integrating clinical data, the TITAN-X Platform can identify responder patterns, facilitating precision medicine approaches for drug development. This ensures that patients receive therapies that are most likely to benefit them according to their unique genetic signatures and clinical profiles, and that are tailored to maximize efficacy, safety, tolerability and minimize adverse side effects. The TITAN-X Platform has shaped the clinical development of omilancor, NX-13 (acquired by Abbvie in March 2024 and now called ABBV-113), NIM-1324 and multiple additional novel MoA targets and drug candidates in preclinical development for I&I indications. About NIMML The NIMML Institute is a 501 (c) (3) non-profit foundation focused on applying transdisciplinary, team-science approaches to precision medicine. The NIMML Institute applies its TITAN-X advanced A.I.-powered platform to large-scale transdisciplinary projects aimed at solving important public health problems through precision medicine. NIMML combines the expertise of immunologists, computational biologists, toxicologists, computational modelers, translational and clinical researchers, and molecular biologists to translate novel scientific discoveries into medicines for human diseases. The Institute is headquartered in Blacksburg, VA. For more information, please visit www.NIMML.org. About NImmune Biopharma NImmune is a late-stage precision inflammation and immunology (I&I) biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by the TITAN-X computational platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s discovery platform is omilancor, a wholly-owned oral, once-daily, gut-restricted, first-in-class therapeutic currently in Phase 3 development, which targets LANCL2 for Ulcerative Colitis and Crohn’s disease. Phase 2 proof-of-concept data for omilancor show potential best in class efficacy and safety. For more information, please visit www.NIMMUNEBIO.com.

Phase 3AcquisitionImmunotherapy

13 Jan 2025

·www.businesswire.com

The NIMML Institute and NImmune Biopharma Announce Publication of Positive First-in-Human Data of NIM-1324, a Phase 2 Candidate for Systemic Lupus Erythematosus, in Clinical and Translational Science

BLACKSBURG, Va.--( BUSINESS WIRE )--The NIMML Institute, (“NIMML”), a 501 (c)(3) nonprofit research institute dedicated to the discovery of novel precision medicines for infectious and autoimmune diseases, today announced publication of positive Phase 1 clinical results for NIM-1324, a first- and potentially best-in-class once-daily, oral, systemically distributed LANCL2 agonist therapeutic for the treatment of Systemic Lupus Erythematosus (SLE). The results, published in Clinical and Translational Science , the journal of the American Society for Clinical Pharmacology and Therapeutics, validate NIM-1324 and the LANCL2 pathway as a safe and well-tolerated novel mechanism of action with no dose-limiting toxicities. As part of a precision medicine research collaboration with NIMML, NImmune Biopharma (“NImmune”), a Phase 3 inflammation and immunology (I&I) private biopharmaceutical company focused on the discovery and development of first-in-class and best-in-class biomarker-driven I&I therapeutics, leveraged NIMML’s A.I.-powered TITAN-X A.I. Platform to identify NIM-1324 as a next-generation precision medicine. Developed as a LANCL2 agonist with improved pharmacokinetics, NIM-1324 is an investigational new drug for SLE, for which the current drugs have a wide array of side effects. “ This study provides exciting first-in-human data for NIM-1324, meeting all primary and secondary endpoints for safety and tolerability to enable further clinical trials in patients,” said Dr. Josep Bassaganya-Riera, Founding Director of NIMML and NImmune Founder & CEO. “ The latest clinical results continue the pattern observed with therapeutics targeting the LANCL2 pathway, which offer a safe and potentially best in class therapeutic effect in multiple I&I indications. The significant progress over the last 12 months by our team to advance the development of wholly-owned NIM-1324 highlights the efficiency of our business model and the TITAN-X A.I. Platform. Just like omilancor, our lead program in IBD currently in pivotal Phase 3 clinical development for ulcerative colitis, NIM-1324 offers urgently needed first-in-class precision medicines for I&I with a novel mechanism of action, no dose-limiting toxicities and the convenience of once daily oral dosing.” Study Design To evaluate the safety of NIM-1324 in humans, the study tested single and multiple ascending doses of NIM-1324 in normal healthy volunteers in a blinded, placebo-controlled clinical design. As NIM-1324 is an investigational new therapy for autoimmune disease, particular notice was taken on the systemic hematological parameters after NIM-1324 dosing. The pharmacokinetics of NIM-1324 were assessed within blood to confirm systemic exposure of NIM-1324 in humans. Among the results of the study, single or multiple oral dosing with NIM-1324 for up to 1500 mg/d did not produce severe adverse effects (AE) or increased total AE rates compared to placebo. No significant findings were observed by biochemistry, coagulation, hematology, or urinalysis relative to placebo. Additionally, dose-proportional change in plasma exposure within the therapeutic range was reported with no accumulation during the dosing period. Oral NIM-1324 upregulated expression of mitochondrial metabolism genes, while downregulating markers of phagocyte activation, in correlation with the whole blood transcriptomic signature generated in preclinical therapeutic efficacy programs. The safety and pharmacokinetic profile discovered were consistent with nonclinical findings, further supporting NIM-1324’s continued clinical development. About NIM-1324 NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to inflammatory and autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in blood from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis, multiple sclerosis and other undisclosed I&I indications. Phase 2-ready NIM-1324 has successfully completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. About Systemic Lupus Erythematosus (SLE) SLE is a chronic autoimmune disorder that causes systemic inflammation and organ damage. SLE can affect the skin, joints, blood vessels, kidneys, lungs, brain, and heart, resulting in fatigue, skin rashes or lesions, fevers, arthritis, lung, heart and kidney damage, seizures, and psychosis. SLE symptomatology often results in low quality of life, and 17% of SLE patients will need a kidney transplant. SLE affects over 1.5 million patients in the United States and over 5 million patients worldwide. With more than half of patients experiencing at least one flare per year or presenting persistently active disease, there is an unmet medical need in SLE for the development of safer and more effective therapeutics. About the TITAN-X Platform The TITAN-X Precision Medicine Platform combines A.I. methodologies, bioinformatics, and advanced computational modeling to accelerate the development of precision medicines to address the unmet clinical needs of patients with autoimmune diseases. Building upon NIMML’s expertise in engineering large-scale computational models to study immunity as a massively and dynamically interacting system, the TITAN-X Platform integrates each step from new target discovery to enabling biomarker-driven precision clinical drug development. Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, the TITAN-X Platform can identify transcriptional predictive signatures by using its advanced A.I. algorithms. By analyzing gene expression patterns and integrating clinical data, the TITAN-X Platform can identify responder patterns, facilitating precision medicine approaches for drug development. This ensures that patients receive therapies that are most likely to benefit them according to their unique genetic signatures and clinical profiles, and that are tailored to maximize efficacy, safety, tolerability and minimize adverse side effects. The TITAN-X Platform has shaped the development of omilancor, NX-13 (acquired by Abbvie in March 2024 and now called ABBV-113), NIM-1324 and multiple additional novel MoA targets for I&I indications. About NIMML The NIMML Institute is a 501 (c)(3) non-profit foundation focused on applying transdisciplinary, team-science approaches to precision medicine. The NIMML Institute applies its TITAN-X advanced A.I.-powered platform to large-scale transdisciplinary projects aimed at solving important public health problems through precision medicine. NIMML combines the expertise of immunologists, computational biologists, toxicologists, computational modelers, translational and clinical researchers, and molecular biologists to translate novel scientific discoveries into medicines for human diseases. The Institute is headquartered in Blacksburg, VA. For more information, please visit www.nimml.org or contact pio@nimml.org . About NImmune Biopharma NImmune is a late-stage precision inflammation and immunology (I&I) biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s discovery platform is omilancor, a wholly-owned oral, once-daily, gut-restricted, first-in-class therapeutic currently in Phase 3 development, which targets LANCL2 for Ulcerative Colitis and Crohn’s disease. Phase 2 proof-of-concept data for omilancor show potential best in class efficacy and safety. For more information, please visit www.NIMMUNEBIO.COM or contact media@nimmunebio.com .

Phase 1Clinical ResultPhase 2Phase 3

100 Deals associated with Amelenodor

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	United States	AbbVie, Inc.	24 Apr 2023
Colitis, Ulcerative	Phase 2	Belgium	AbbVie, Inc.	24 Apr 2023
Colitis, Ulcerative	Phase 2	Italy	AbbVie, Inc.	24 Apr 2023
Colitis, Ulcerative	Phase 2	Poland	AbbVie, Inc.	24 Apr 2023
Crohn Disease	Phase 1	United States	Landos Biopharma, Inc.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05785715 (CTgov)	Phase 2	Colitis, Ulcerative	81	NX-13 (Induction Period: NX-13 250 mg)	etcfdvpfpb(vniqcwtvnj) = nzzfcgfidw xslqhawyzh (ixljpzithb, 0.41) View more	-	15 Jun 2026
				NX-13 (Induction Period: NX-13 750 mg)	etcfdvpfpb(vniqcwtvnj) = catjfmypvj xslqhawyzh (ixljpzithb, 0.40) View more
NCT04862741 (Literature) Manual	Phase 1	Colitis, Ulcerative	38	NX-13	wnaesqcghg(qmniqlydja) = none xnmacgnihv (rcsynmfbjt ) View more	Positive	11 Nov 2023
				Placebo
NCT05785715 (UEGW2023)	Phase 2	Colitis, Ulcerative	-	NX-13 250mg IR	wbppgnknep(fybwynziwo) = eaiiwbgsgp mibrrdkixu (qsiqzjevmk ) View more	-	15 Oct 2023
				NX-13 500mg IR	wbppgnknep(fybwynziwo) = iegfpboent mibrrdkixu (qsiqzjevmk ) View more
UEGW2023	Not Applicable	Colitis, Ulcerative	-	NX-13 250mg Immediate Release	jpmretwsoq(tclwaqwqal) = nevijlskrm akgwyetkdq (klmjlhlymf )	-	15 Oct 2023
				NX-13 500mg Immediate Release	jpmretwsoq(tclwaqwqal) = mqlszjubmy akgwyetkdq (klmjlhlymf )
NCT04862741 (Corporate Publications) Manual	Phase 1	Colitis, Ulcerative	38	NX-13	qeapfbulne(rkbwoctwnj) = no serious adverse events (SAEs) were reported pmvmcjywqx (npfmbpsuml )	Positive	03 Aug 2022
				Placebo
NCT04458805 (PipelineReview) Manual	Phase 1	Inflammatory Bowel Diseases	56	NX-13	jusjsmisgf(kveswvmiur) = No serious adverse events were reported srattbdylo (qnldkqitqz ) View more	Positive	04 Mar 2021
				Placebo

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis