Pouchitis

MRM Health Reports Positive Topline Results from Phase 2a Clinical Study with MH002 in Mild-to-Moderate Ulcerative Colitis

Retrieved on: 
Tuesday, September 19, 2023
Health, Other Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Therapy, MES, Icahn School of Medicine at Mount Sinai, MRM, Mount Sinai, Wilcoxon, Trial of the century, Vancomycin, Patient, CGMP, Pouchitis, KU Leuven, Disease, Safety, Pharmaceutical industry, Fine chemical, Medicine, UC

MRM Health NV, a clinical-stage biopharmaceutical company focused on developing next-generation live microbiome consortia therapeutics, today reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC).

Key Points: 
  • MRM Health NV, a clinical-stage biopharmaceutical company focused on developing next-generation live microbiome consortia therapeutics, today reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC).
  • MRM Health’s MH002-UC-201 study was a multi-center, double-blind, randomized, placebo-controlled trial in 45 UC patients at multiple clinical sites in Belgium, Poland and Czech Republic.
  • The study was designed to evaluate safety (primary endpoint), initial efficacy and mechanistic effects of MH002 over eight weeks, with a further eight-week extension period.
  • Ludo Haazen, Chief Medical Officer at MRM Health, added: “This first clinical study enables us to move forward with our clinical programme in UC.

Takeda Announces Results From Phase 4 Vedolizumab Study in Patients With Chronic Pouchitis Published in New England Journal of Medicine

Retrieved on: 
Thursday, March 30, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Inflammation, The New England Journal of Medicine, University, Week, Chronic pain, TAK, IPAA, Ulcerative colitis, NEJM, Fecal incontinence, Kennedy Institute, UC, Patient, European, Pouchitis, Treatment, University of Oxford, Pharmaceutical industry, Birth control, Takeda, Gastroenterology

Takeda ( TSE:4502/NYSE:TAK ) today confirmed that the New England Journal of Medicine (NEJM) has published positive data from the Phase 4 EARNEST study of vedolizumab for the treatment of chronic pouchitis.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today confirmed that the New England Journal of Medicine (NEJM) has published positive data from the Phase 4 EARNEST study of vedolizumab for the treatment of chronic pouchitis.
  • The NEJM article is titled “ Vedolizumab for the Treatment of Chronic Pouchitis ”.
  • A potentially curative surgical option for ulcerative colitis (UC) is total proctocolectomy, followed by creation of an ileal pouch anal anastomosis (IPAA) to aid in stool retention.
  • The publication concluded that vedolizumab was more effective than placebo for inducing remission in chronic pouchitis after IPAA for patients with UC.

Applied Molecular Transport Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 9, 2023
AMTI, Partnership, ECCO, Rheumatoid arthritis, R, Food and Drug Administration, SAN, Patient, FDA, G&A, Food, Pouchitis, Research, AMT, Pharmaceutical industry, Cryptocurrency

SOUTH SAN FRANCISCO, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Research and development expenses increased by $18.4 million for the year ended December 31, 2022 compared to the year ended December 31, 2021.
  • General and administrative expenses increased by $8.1 million for the year ended December 31, 2022 compared to the year ended December 31, 2021.
  • Net loss for the fourth quarter of 2022 was $22.6 million, compared to a net loss of $30.2 million for the same period in 2021.
  • As of December 31, 2022, cash and cash equivalents were $61.1 million compared to $159.8 million for the year ended December 31, 2021.

Applied Molecular Transport Announces Top-line Phase 2 Results from LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis

Retrieved on: 
Thursday, December 22, 2022
AMTI, AMT, Orphan, Pouchitis, Patient, Mayo, Safety, UC, European, Ulcerative colitis, CR, Pharmaceutical industry

“We thank our patients and sites for participating in the LOMBARD trial.

Key Points: 
  • “We thank our patients and sites for participating in the LOMBARD trial.
  • In the LOMBARD trial, patients received once-daily oral AMT-101 3mg or placebo in a 2:1 ratio.
  • The objectives of the LOMBARD trial were to assess the safety and efficacy of AMT-101 in patients with moderate-to-severe UC.
  • Of the 105 patients, 17.1% (12/70) of patients treated in the monotherapy arm (AMT-101 3mg) achieved clinical remission versus 20.0% (7/35) in patients receiving placebo at week 12.

Applied Molecular Transport Announces FDA Orphan Drug Designation Granted to AMT-101 for Treatment of Pouchitis

Retrieved on: 
Thursday, November 10, 2022
Quality of life, AMTI, SAN, GLOBE, Rheumatoid arthritis, Ulcerative colitis, Marketing, U.S. Securities and Exchange Commission, Pouchitis, Pain scale, Abdominal pain, FDA, Food, Nasdaq, IE, Orphan, UC, Technology, Population, CMV, Incontinence, Magazine, Securities Act of 1933, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fecal incontinence, IBD, SEC, Chronic pain, Safety, Ulcer, Securities Exchange Act of 1934, Patient, CA, Kelly Gebo, IPAA, Inflammation, Autoimmunity, Disease, Program, AMT, Terminology, Colectomy, OR, GMP, Growth, Security (finance), Drug Quality and Security Act, Cytomegalovirus, RA, SAE, Pharmaceutical industry, Vaccine

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation for AMT-101 in patients with pouchitis, an indication with significant unmet medical need and no current FDA-approved products.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation for AMT-101 in patients with pouchitis, an indication with significant unmet medical need and no current FDA-approved products.
  • Rapid onset of stool frequency response was demonstrated as early as week 2 in both dosage groups and was maintained through the duration of treatment.
  • Acute pouchitis often responds to antibiotic treatment but up to 50% of pouchitis patients develop chronic pouchitis where patients often relapse on or do not respond to antibiotic therapy.
  • Active transport is an efficient mechanism that uses the cells own machinery to transport materials across the IE barrier.

Cosmo announces FDA grants orphan-drug designation of rifamycin for treatment of pouchitis

Retrieved on: 
Saturday, October 22, 2022
IPAA, Incontinence, Colon, Hospital, Endoscopy, Tenesmus, Patient, XETRA, Ansamycin, Medtronic, ODD, GI, Partnership, Orphan drug, Degenerative disease, Rectum, Malnutrition, Pouchitis, CEO, UC, Incidence, Ulcerative colitis, Fever, C43, Dehydration, FDA, Pharmaceutical industry, EU

Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (Cosmo) announces that the FDA has granted the orphan-drug designation request of rifamycin for treatment of pouchitis.

Key Points: 
  • Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (Cosmo) announces that the FDA has granted the orphan-drug designation request of rifamycin for treatment of pouchitis.
  • Cosmo has conceived and developed a novel formulation to deliver Rifamycin SV, an antibiotic belonging to the Ansamycin family, to treat pouchitis.
  • The granting of the Orphan Drug Designation (ODD) by the FDA is an essential step to streamline and accelerate the development of a much-needed treatment.
  • Alessandro Della Ch, CEO of Cosmo, said: The grant of the ODD for Rifamycin from the FDA to treat pouchitis is another major advancement of our GI pipeline of innovative products.

Pouchitis Epidemiology Forecasts, 2032: Focus on 7MM - United States, Germany, Spain, Italy, France, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 27, 2022
General Health, Surgery, Infectious Diseases, Other Health, Health, SME, Diagnosis, United Kingdom, Disease, Epidemiology, Classification, Table, Lists of people executed in the United States, Population, Vaccine, Dentistry, Medical device, Renewable energy, Pouchitis

This "Pouchitis - Epidemiology Forecast to 2032" report delivers an in-depth understanding of the disease, historical and forecasted Pouchitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Key Points: 
  • This "Pouchitis - Epidemiology Forecast to 2032" report delivers an in-depth understanding of the disease, historical and forecasted Pouchitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
  • The Pouchitis epidemiology report gives a thorough understanding of the Pouchitis by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis.
  • The report covers the detailed information of the Pouchitis epidemiology scenario in seven major countries (US, EU5, and Japan).
  • The Pouchitis epidemiology covered in the report provides historical as well as forecasted Pouchitis epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2019 to 2032.

MRM Health Starts Clinical Trial with Next-Generation Optimized Consortium Therapeutic MH002 in Pouchitis

Retrieved on: 
Tuesday, June 28, 2022
Research, Other Health, Pharmaceutical, Biometrics, Other Education, University, Education, Clinical Trials, Science, Neurology, Biotechnology, FDA, Health, Medication, UC, Patient, CEO, CGMP, Colectomy, Health, Immunosuppression, UZ Leuven, MRM, Disease, FAMHP, Inflammation, Compliance, Ulcerative colitis, Therapy, Dysbiosis, IBD, Technology, Type 2, Spondyloarthropathy, DuPont, Doctor of Philosophy, Type 2 diabetes, Autoimmune disease, Entrepreneurship, Inflammatory bowel disease, Immunomodulation, Federal Agency for Medicines and Health Products, Safety, MD, Federal agency, Pharmaceutical industry, Vaccine, NAFLD, Pouchitis

MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis.

Key Points: 
  • MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis.
  • MRM Healths Phase 2 study in Pouchitis is a multi-center, open label trial which will enrol up to 20 acute Pouchitis patients.
  • MRM Health NV, Ghent, Belgium, is a biopharmaceutical company focused on the development of next-generation optimized consortium therapeutics based on the human microbiome.
  • Its most advanced program MH002 is an optimized consortium of 6 rationally-selected and well-characterized commensal strains.

MRM Health Starts Clinical Trial with Next-Generation Optimized Consortium Therapeutic MH002 in Pouchitis

Retrieved on: 
Tuesday, June 28, 2022
Medication, UC, Patient, CEO, CGMP, Colectomy, Health, Immunosuppression, GLOBE, UZ Leuven, MRM, Disease, FAMHP, Inflammation, Compliance, Ulcerative colitis, Therapy, Dysbiosis, IBD, Technology, Type 2, Spondyloarthropathy, DuPont, Doctor of Philosophy, Type 2 diabetes, Autoimmune disease, Entrepreneurship, Inflammatory bowel disease, Immunomodulation, Federal Agency for Medicines and Health Products, Safety, MD, Federal agency, Pharmaceutical industry, Vaccine, NAFLD, Pouchitis

MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis.

Key Points: 
  • MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis.
  • MRM Healths Phase 2 study in Pouchitis is a multi-center, open label trial which will enrol up to 20 acute Pouchitis patients.
  • MRM Health NV, Ghent, Belgium, is a biopharmaceutical company focused on the development of next-generation optimized consortium therapeutics based on the human microbiome.
  • Its most advanced program MH002 is an optimized consortium of 6 rationally-selected and well-characterized commensal strains.

Applied Molecular Transport Announces Positive Top-line Phase 2 Results from FILLMORE Trial of Oral AMT-101 in Patients with Chronic Pouchitis

Retrieved on: 
Monday, April 25, 2022
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SOUTH SAN FRANCISCO, Calif., April 25, 2022 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today announced positive top-line Phase 2 results from the FILLMORE monotherapy trial for AMT-101 in patients with chronic pouchitis, an orphan indication with significant unmet medical need and no current FDA-approved therapies. AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, which is also in development for the treatment of ulcerative colitis (UC) and rheumatoid arthritis (RA).

Key Points: 
  • The FILLMORE independent DMC recommends advancing AMT-101 to Phase 3 with the 3mg dose in chronic pouchitis, based on its review of safety and efficacy data available to date.
  • The live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events .
  • FILLMORE is a Phase 2 double-blinded trial that evaluated the safety and efficacy of orally administered AMT-101 monotherapy, over 12 weeks, in patients with chronic pouchitis.
  • Acute pouchitis often responds to antibiotic treatment but up to 50% of pouchitis patients develop chronic pouchitis where patients often relapse on or do not respond to antibiotic therapy.