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Immune System Diseases

Digestive System Disorders

Skin and Musculoskeletal Diseases

Small molecule drug

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AHR(Aryl hydrocarbon receptor)	1

This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo, Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending Sponsor approval, if it appears that less than 60 patients will complete the study.

Start Date01 Jul 2010

Sponsor / Collaborator

Natrogen Therapeutics International, Inc.

100 Clinical Results associated with Natrogen Therapeutics International, Inc.

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0 Patents (Medical) associated with Natrogen Therapeutics International, Inc.

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3

Literatures (Medical) associated with Natrogen Therapeutics International, Inc.

01 Jan 2016·Biochemical PharmacologyQ2 · MEDICINE

Interaction of a small molecule Natura-α and STAT3-SH2 domain to block Y705 phosphorylation and inhibit lupus nephritis

Q2 · MEDICINE

Article

Author: Tsao, Allen ; Melikian, Maxime ; Wang, Long G ; Bertho, Gildas ; Xue, Chengsen ; Han, Liying ; Mencher, Simon K ; Solangi, Karim ; Chiao, J W ; Fallon, John ; Wang, Luxi

A small molecule, Natura-α, a clinical stage investigational new drug for certain inflammatory diseases, has been evaluated for drug interaction with STAT3 and inhibiting systemic lupus erythematosus (SLE). Studies have revealed that it selectively inhibits STAT3-Y705 phosphorylation and, suppresses pro-inflammatory cytokines, stimulates anti-inflammatory cytokine IL-10, thereby skewing T cell differentiation from the Th1/Th17 lineages toward the Treg lineage. The potential binding of the drug to STAT3 protein has been investigated with a computational modeling and docking simulation using X-ray crystal structure of the STAT3β homodimer. Natura-α was shown to directly bind to SH2 domain of STAT3 and forms H-bonds with amino acids Glu594 and Arg609. The phosphorylation of Y705 was prevented and making the formation of STAT3 homodimer impossible, thereby blocking STAT3 activation. The in vivo efficacy of Natura-α in SLE was evaluated in a bioassay with NZB/W female mice. Mice at week 19 were given orally Natura-α at 25 or 75 mg/kg, once a day, 5 days per week for 29 weeks. Mice were monitored weekly until 52 weeks of age. Both dosages were effective to reduce proteinuria and significantly improved animal survival rate. The renal functions were preserved with glomerular lesions reversed, which paralleled with decreased C3 deposit. The numbers of kidney cells stained with phosphorylated STAT3-Y705 remarkably decreased, demonstrating blocking of Y-705 phosphorylation by the treatment. Since NZB/W mice develop nephritis which resembles SLE in men, the data strongly suggests that Natura-α may be a potential effective therapeutic agent for lupus.

01 May 2013·The Journal of Immunology

Natura-alpha, a novel STAT3-Y705 inhibitor in treating systemic lupus erythematosus in NZB/W female mice (P5157)

Author: Chiao, Jen-Wei ; Han, Liying ; Wang, Longgui ; Fallon, John ; Tsao, Allen

AbstractSystemic lupus erythematosus (SLE) is a complex autoimmune disease. Increases in Th1/Th17 cells, and decreases in Treg cells, have been observed in patients with SLE. Natura-α, a synthetic small molecule inhibits STAT3-Y705 phosphorylation and regulates Th1/Th17 and Treg. The potential of Natura-α as a SLE therapeutics was explored. The SLE model NZB/W female mice which develops lupus nephritis were used after the disease was confirmed at week 19. One group (n=10) was given orally vehicle, and the other groups given Natura-α at 25 or 75 mg/kg, once/day, 5 days/week for 29 weeks. Mice were monitored until 52 weeks of age. Proteinuria in control mice was elevated at week 31, followed with sharp increase reaching greater than 1000 mg/dL at week 44. The levels in the two Natura-α-treated groups essentially maintained at stable lower level (150+100mg/dL at 25mg/kg, and 115+127mg/dL at 75mg/kg). Control mice began to die at week 38. At week 48, 60% of mice died in the vehicle group. In sharp contrast, all mice in the Natura-α-treated groups were survived (P<0.001). Glomerular lesion in the control mice reached maximal at week 38, with over 85% exhibited severe lesions. The glomerular lesions in the Natura-α-treated groups were around the baseline level, i.e. approximately 20%. The treatments with the Natura-α significantly reduced proteinuria, prevented and reversed glomerular lesions, and improved survival, suggesting this novel STAT3-Y705 inhibitor is a potential SLE inhibitor.

ImmunoTargets and Therapy

Current Strategies in Treating Cytokine Release Syndrome Triggered by Coronavirus SARS-CoV-2

Review

Author: Wang, Luxi ; Wang, Long G

Since the beginning of the SARS-CoV-2 pandemic, the treatments and management of the deadly COVID-19 disease have made great progress. The strategies for developing novel treatments against COVID-19 include antiviral small molecule drugs, cell and gene therapies, immunomodulators, neutralizing antibodies, and combination therapies. Among them, immunomodulators are the most studied treatments. The small molecule antiviral drugs and immunoregulators are expected to be effective against viral variants of SARS-CoV-2 as these drugs target either conservative parts of the virus or common pathways of inflammation. Although the immunoregulators have shown benefits in reducing mortality of cytokine release syndrome (CRS) triggered by SARS-CoV-2 infections, extensive investigations on this class of treatment to launch novel therapies that substantially improve efficacy and reduce side effects are still warranted. Moreover, great challenges have emerged as the SARS-CoV-2 virus quickly, frequently, and continuously evolved. This review provides an update and summarizes the recent advances in the treatment of COVID-19 and in particular emphasized the strategies in managing CRS triggered by SARS-CoV-2. A brief perspective in the battle against the deadly disease was also provided.

100 Deals associated with Natrogen Therapeutics International, Inc.

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100 Translational Medicine associated with Natrogen Therapeutics International, Inc.

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Pipeline

Pipeline Snapshot as of 10 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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