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 with Moderate to Severe Ulcerative Colitis - NX-13-201/M25-484

Start Date16 Oct 2023

Sponsor / Collaborator

Landos Biopharma, Inc.

NCT05785715

/ Active, not recruitingPhase 2

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.

100 Clinical Results associated with Amelenodor

100 Translational Medicine associated with Amelenodor

100 Patents (Medical) associated with Amelenodor

Literatures (Medical) associated with Amelenodor

31 May 2024·Journal of Crohn's and 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 ; Dubinsky, Marla ; Colombel, Jean-Frederic ; Verstockt, Bram ; Schreiber, Stefan ; Yarur, Andres ; Peyrin-Biroulet, Laurent ; Vermeire, Severine ; Panaccione, Remo ; Lichtiger, Simon ; Rieder, Florian ; Danese, Silvio ; Siegmund, Britta ; Mosig, Rebecca ; Feagan, Brian G

AbstractBackground and AimsNX-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].MethodsWe 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.ResultsThirty-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.ConclusionsNX-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: Li, Gaocai ; Zhang, Yukun ; Tong, Bide ; Ma, Liang ; Wang, Kun ; Feng, Xiaobo ; Song, Yu ; Wu, Xinghuo ; Zhu, Dingchao ; Liang, Huaizhen ; Li, Shuai ; Zhang, Weifeng ; Gao, Yong ; 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.

02 Jan 2022·Drug and Chemical ToxicologyQ4 · MEDICINE

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

Q4 · MEDICINE

Article

Author: Hontecillas, Raquel ; Chauhan, Jyoti ; Ehrich, Marion ; Bassaganya-Riera, Josep ; Leber, Andrew ; Zoccoli-Rodriguez, Victoria

Nucleotide-binding oligomerization domain, leucine rich repeat containing X1 (NLRX1) is an emerging therapeutic target for a spectrum of human diseases. NX-13 is a small molecule therapeutic designed to target and activate NLRX1 to induce immunometabolic changes resulting in lower inflammation and therapeutic responses in inflammatory bowel disease (IBD). This study investigates the safety of NX-13 in a seven-day, repeat-dose general toxicity study in male and female Sprague Dawley rats at oral doses of 500 and 1000 mg/kg. Weights, clinical signs, functional observational battery, clinical pathology and histopathology were used for evaluation. Daily oral dosing of NX-13 up to 1000 mg/kg did not result in any changes in weight, abnormal clinical signs or behavior. No significant differences were observed between treated and control rats in hematology or blood biochemistry. Histopathological evaluation of 12 tissues demonstrated no differences between controls and treated rats. There were no changes in weights of brain, heart, kidney, liver or spleen. Pharmacokinetic analysis of a single oral dose of NX-13 at 10 mg/kg in Sprague Dawley rats provided a maximum plasma concentration of 57 ng/mL at 0.5 h post-dose. 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.

News (Medical) associated with Amelenodor

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

06 Sep 2024

·www.pharmaceutical-technology.com

NImmune and BioTherapeutics partner on precision medicine development

The deal will aid NImmune in the development of both animal and computational models for inflammatory and autoimmune diseases. Credit: sergey kolesnikov/Shutterstock. NImmune Biopharma has entered a research partnership with BioTherapeutics, aimed at propelling the development of new precision medicines in the field of inflammation and immunology. The deal will enhance NImmune’s capabilities in precision immunology by leveraging BioTherapeutics’ extensive preclinical services and regulatory expertise. NImmune will benefit from BioTherapeutics’ animal models, including pig models for inflammatory bowel disease, pharmacokinetics/pharmacodynamics analysis capabilities and specialised regulatory infrastructure for product testing. The deal will also aid in mechanism of action validation studies and the development of both animal and computational models of autoimmune and inflammatory diseases. BioTherapeutics chief scientific officer Dr Raquel Hontecillas stated: “We are excited to collaborate across teams in support of the development of much-needed therapeutics by providing our highly sophisticated computational and preclinical services, including our proprietary efficacy animal models of autoimmune and inflammatory disease. See Also: Investment opportunities in atopic dermatitis may drive innovation EC approves Merck’s Keytruda-Padcev combo for urothelial cancer “The unique drug development ecosystem created here in Blacksburg enables and equips our organisations to develop safer and more effective therapeutics at an increasingly efficient and accelerated pace.” The partnership with BioTherapeutics adds to NImmune’s existing research and development (R&D) collaboration with the NIMML Institute. Together, they will form a scientific innovation ecosystem that enables transdisciplinary teams to collaborate from discovery through various development phases. This ecosystem has already yielded significant clinical and commercial success, as evidenced by the development of NX-13 and its subsequent acquisition by AbbVie . NImmune founder and CEO Dr Josep Bassaganya-Riera stated: “The collaboration with BioTherapeutics is a crucial extension of NImmune’s innovative R&D ecosystem that is enabling our team to create safer and more effective immunoregulatory therapeutics that address the unmet clinical needs of patients with inflammatory and autoimmune diseases. “Through NImmune’s strategic partnerships with both the NIMML Institute and BioTherapeutics, we have created a best-in-class scientific ecosystem capable of accelerating the pipeline — from AI-enabled target discovery and validation using the TITAN-X platform to preclinical animal modelling to clinical testing and ultimately commercialisation.”

Acquisition

05 Sep 2024

·www.businesswire.com

NImmune Biopharma Announces R&D Collaboration with BioTherapeutics, Inc. to Advance the Next Wave of Inflammation and Immunology Precision Medicines

BLACKSBURG, Va.--( BUSINESS WIRE )-- NImmune Biopharma ("NImmune”), a late-clinical-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics, today announced a research collaboration with BioTherapeutics, Inc. (“BioTherapeutics”), a clinical-stage biotech company that combines advanced computational modeling with translational and clinical experimentation to accelerate the development of novel products. The collaboration strengthens NImmune’s precision immunology capabilities by providing access to BioTherapeutics’ preclinical services and regulatory capabilities for product testing, mechanism of action validation studies, and development of animal and computational models of inflammatory and autoimmune disease. NImmune will also gain access to BioTherapeutics’ proprietary animal models of disease, including its unique pig models of IBD, PK/PD analysis capabilities and expert regulatory infrastructure. Dr. Raquel Hontecillas, BioTherapeutics Chief Scientific Officer, stated, “ We are excited to collaborate across teams in support of the development of much-needed therapeutics by providing our highly sophisticated computational and preclinical services, including our proprietary efficacy animal models of autoimmune and inflammatory disease. The unique drug development ecosystem created here in Blacksburg enables and equips our organizations to develop safer and more effective therapeutics at an increasingly efficient and accelerated pace.” NImmune’s partnership with BioTherapeutics complements an existing R&D partnership with NIMML Institute , creating a unique scientific innovation ecosystem for transdisciplinary teams to collaborate from discovery through various development phases. This ecosystem demonstrated significant clinical and commercial success this year with BioTherapeutics and NIMML Institute having enabled the development of NX-13 and its acquisition by AbbVie, Inc. (NYSE: ABBV). " The collaboration with BioTherapeutics is a crucial extension of NImmune's innovative R&D ecosystem that is enabling our team to create safer and more effective immunoregulatory therapeutics that address the unmet clinical needs of patients with inflammatory and autoimmune diseases,” said Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune. “ Through NImmune’s strategic partnerships with both the NIMML Institute and BioTherapeutics, we have created a best-in-class scientific ecosystem capable of accelerating the pipeline—from A.I.-enabled target discovery and validation using the TITAN-X platform to preclinical animal modeling to clinical testing and ultimately commercialization. The regulatory infrastructure, preclinical resources, and leading proprietary models of disease and pathology developed and honed at BioTherapeutics allow us to focus NImmune’s organizational energy squarely on advancing clinical development of our immunoregulatory therapeutic pipeline." “ We’re proud to enter this strategic partnership, which combines BioTherapeutics’ validated models of inflammatory and autoimmune diseases with our expertise in rapidly translating fundamental scientific discoveries in immunology into safer and more effective medicines for patients with immune-mediated diseases such as ulcerative colitis, Crohn’s disease, psoriasis, rheumatoid arthritis, asthma, and systemic lupus erythematosus,” continued Dr. Bassaganya-Riera. “ We look forward to the ongoing collaboration between BioTherapeutics and NImmune, as well as the NIMML Institute, to significantly accelerate the clinical development of our high-conviction drug candidates.” About NImmune Biopharma NImmune is a late-stage precision immunology 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 Phase 3-ready oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis and Crohn’s disease with registration-directed pivotal clinical trials planned for 2H’23. 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 . About BioTherapeutics, Inc. BioTherapeutics, Inc., a clinical-stage biotech company that synergistically combines the power of advanced computational modeling with translational and clinical experimentation to accelerate the development of novel products for precision medicine and health. The company is headquartered in Blacksburg, VA. For more information, please visit www.biotherapeuticsinc.com .

Phase 2Acquisition

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	BE	AbbVie, Inc.	24 Apr 2023
Colitis, Ulcerative	Phase 2	US	AbbVie, Inc.	24 Apr 2023
Colitis, Ulcerative	Phase 2	IT	AbbVie, Inc.	24 Apr 2023
Colitis, Ulcerative	Phase 2	PL	AbbVie, Inc.	24 Apr 2023
Crohn Disease	Phase 1	US	Landos Biopharma, Inc.	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04862741 (Literature) Manual	Phase 1	Colitis, Ulcerative	38	NX-13	(psydujfabu) = none wnvyuqmwzq (tmwggyqwwd ) View more	Positive	11 Nov 2023
				Placebo
UEGW2023	Not Applicable	Colitis, Ulcerative	-	NX-13 250mg Immediate Release	knrsrxmdsg(pyomodardc) = rgvtelzpet olsfaddhyr (wbekioyafl )	-	15 Oct 2023
				NX-13 500mg Immediate Release	knrsrxmdsg(pyomodardc) = qzxixwzoiz olsfaddhyr (wbekioyafl )
UEGW2023	Not Applicable	Colitis, Ulcerative	-	NX-13 250mg IR	nzbprxtxuh(dqvvxzymqt) = inkloiolai bpoolxuqdy (ttrkossyqm ) View more	-	15 Oct 2023
				NX-13 500mg IR	nzbprxtxuh(dqvvxzymqt) = yixaweplzh bpoolxuqdy (ttrkossyqm ) View more
NCT04862741 (Corporate Publications) Manual	Phase 1	Colitis, Ulcerative	38	NX-13	(kqvtjhmpkr) = no serious adverse events (SAEs) were reported venldcemwx (jaspjxxrhu )	Positive	03 Aug 2022
				Placebo
NCT04458805 (PipelineReview) Manual	Phase 1	Inflammatory Bowel Diseases	56	NX-13	(xhfghivfhj) = No serious adverse events were reported xpwjpzshlc (ixenuskzgl ) View more	Positive	04 Mar 2021
				Placebo

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