Clostridioides

 Pivotal Phase 3 Efficacy and Safety Data for Ferring’s RBX2660 Published in Drugs

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Lunedì, Novembre 7, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Symptoms of COVID-19, Therapy, Clostridioides difficile (bacteria), Recurrence, CDC, Centers for Disease Control and Prevention, CDI, Multimedia, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Șaeș, ClinicalTrials.gov, Clostridioides difficile infection, Clostridioides, FDA, Variometer, Safety, Incidence, AES, CD3, Center, Ferring Pharmaceuticals, PUNCH, Nausea, Fever, Medication, Risk, Health, Diarrhea, Hospital, CP, Inflammation, Journal of Managed Care & Specialty Pharmacy, Maternal health, Reproductive medicine, Gastroenterology, Colitis, Diagnosis, Patient, Pain, Clostridium difficile, Mayo Clinic, Pharmaceutical industry, Medical device, Dietary supplement, Animal

RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent CDI (rCDI) after antibiotic treatment.

Key Points: 
  • RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent CDI (rCDI) after antibiotic treatment.
  • The published manuscript, titled, Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial With a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection is available online .
  • Participants were followed up to eight weeks for the primary efficacy analysis, and up to six months for efficacy and safety analyses.
  • Participants were followed up to eight weeks for the efficacy analysis, and up to 24 months for the safety analysis.

Theriva Biologics Announces First Patient Dosed in Second Cohort of Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

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Giovedì, Novembre 3, 2022
Patient, VRE, Piperacillin/tazobactam, Infection, Neoplasm, Private Securities Litigation Reform Act, Washington University School of Medicine, Form 8-K, Therapy, Growth, Time, Maintenance, Washington University in St. Louis, Cohort, IV, CGMP, CDI, Sale, GLOBE, Meropenem, Vancomycin, Clostridioides difficile infection, Clostridioides, Washington University School of Law, NYSE, Safety, Incidence, Terminology, Marketing, Subclinical infection, Degenerative disease, HCT, Annual report, Cefepime, Hematological Cancer Research Investment and Education Act, Clinical trial, Fever, GI, Risk, VCN, Absorption, IAP, SEC, Cancer, Pharmaceutical industry

ROCKVILLE, Md., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the first patient has been dosed in Cohort 2 of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

Key Points: 
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • The trial is designed to evaluate the safety, tolerability, and potential absorption of oral SYN-004 (150 mg q.i.d.
  • for a maximum of 28 days) into the systemic circulation of allogeneic HCT recipients who receive an IV antibiotic to treat fever.
  • Patients in Cohorts 2 and 3 will be administered piperacillin/tazobactam and cefepime respectively, each of which can be metabolized by SYN-004.

Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022 Conference Call and Provide Business Update

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Martedì, Novembre 1, 2022
Security (finance), Marketing, MRSA, Clostridioides, DNA, Infection, IIIC, Clostridioides difficile (bacteria), Securities and Exchange Commission (Philippines), Annual report, Methicillin-resistant Staphylococcus aureus, Gram, VRE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, CDI, Maintenance, GAIN, Private Securities Litigation Reform Act, Company, Clostridioides difficile infection, FDA, Enterococcus, Patient, Food, Fast Track, QIDP, CDC, Act, Firmicutes, GPSS, DRSP, Pharmaceutical industry, Actinobacteria

It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat.
  • The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.

Ferring Presents Seven New Analyses at ACG 2022 for RBX2660, Its Investigational Microbiota-Based Live Biotherapeutic

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Lunedì, Ottobre 24, 2022
Health, Science, Pharmaceutical, Research, Clinical Trials, Hospital, Population, American College of Gastroenterology, Clostridioides difficile (bacteria), Variometer, The Rheumatoid Arthritis Quality of Life Questionnaire, Diarrhea, CDI, Clostridioides difficile infection, Multimedia, Data, Clostridioides, Sex, Public health, ACG, Health, PUNCH, Ferring Pharmaceuticals, Safety, Recurrence, American College, Pharmaceutical industry, Patient

Ferring Pharmaceuticals today announced the presentation at the American College of Gastroenterology ( ACG ) 2022 Annual Scientific Meeting of seven analyses for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.

Key Points: 
  • Ferring Pharmaceuticals today announced the presentation at the American College of Gastroenterology ( ACG ) 2022 Annual Scientific Meeting of seven analyses for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.
  • Among responders, improvements from baseline to week 8 were statistically significant (all p
  • Adjusted analyses among responders found a difference favoring RBX2660 versus placebo at week 8 for the mental domain (7.4, 95% CI: [0.33, 14.43], P
  • Four additional analyses were presented at ACG 2022, which looked at the efficacy and safety of RBX2660 across different populations, including participants with underlying comorbidities.

PCTL/21st Century Announce New Hospital Contract

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Martedì, Ottobre 18, 2022
Organic compound, MRSA, SEC, PCT, Clostridioides difficile (bacteria), 460, PCTL, Patient, COO, Staphylococcus aureus, Clostridioides, Goal, N, Department, OSG, United States Department of Health and Human Services, GLOBE, Climate change, OTC Markets Group, ICS, Hypochlorous acid, Pharmaceutical industry, Health insurance

The goal was to bring a low-toxic, environmentally conscious, and sustainable onsite generating system to the healthcare industry to control healthcare-associated infections.

Key Points: 
  • The goal was to bring a low-toxic, environmentally conscious, and sustainable onsite generating system to the healthcare industry to control healthcare-associated infections.
  • OSG 460 D is a hypochlorous acid disinfectant that can be made fresh at any time.
  • Listed on the EPAs emerging pathogens N and Q lists, little to no personal protective equipment is needed to apply the disinfectant.
  • The company acquires and holds rights to innovative products and technologies, which are commercialized through its wholly owned operating subsidiaries, Paradigm Convergence Technologies Corporation (PCT Corp), 21st Century Healthcare, Inc. and 21st Century Energy Solutions, Inc.

Summit Therapeutics to Present Ri-CoDIFy Trial Results for Microbiome-Sparing Ridinilazole at IDWeek 2022

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Giovedì, Ottobre 13, 2022
Infection, Private Securities Litigation Reform Act, Food and Drug Administration Amendments Act of 2007, Susceptibility, NASDAQ, CDI, Pharmacist, Nasdaq, Treatment, Next Stage with You, Society of Infectious Diseases Pharmacists, Journal, Commensalism, Infectious Diseases Society of America, Vancomycin, Safety, Poster, Quality of life, Randomness, SMMT, Knowledge, Company, Marketing, Summit, PIDS, GLOBE, Clinical trial, The Journal of Infectious Diseases, Ridinilazole, Research, Security (finance), Giovanni, Trial of the century, U.S. Securities and Exchange Commission, IDSA, Diarrhea, Risk, Clostridioides difficile (bacteria), Patient, Clostridioides difficile infection, Coronavirus, Food, Efficacy, Society, Recurrence, COVID-19, Epidemiology, Pharmaceutical industry, Vaccine, Medical device, Clostridium, Clostridioides, DRS

Menlo Park, California, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Summit Therapeutics Inc. (NASDAQ: SMMT) (Summit, we, or the Company) and its product candidate, ridinilazole, will have an oral podium presentation and a poster presentation at IDWeek 2022.

Key Points: 
  • Menlo Park, California, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Summit Therapeutics Inc. (NASDAQ: SMMT) (Summit, we, or the Company) and its product candidate, ridinilazole, will have an oral podium presentation and a poster presentation at IDWeek 2022.
  • In the Ri-CoDIFy study, ridinilazole resulted in a meaningful reduction in the rate of recurrence of C. diff.
  • infection (8.1% vs 17.3%) and achieved a numerically higher sustained clinical response1 rate (73.0% vs 70.7%) than vancomycin.
  • We are pleased to inform that the results of our clinical study validated the assertions of Drs.

DEINOVE to present data on DNV3837 at the ESCMID/ASM conference in Dublin

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Mercoledì, Ottobre 5, 2022
CDC, Constipation, Epithelium, White Blood Cells, Infection, Clostridioides difficile (bacteria), Feces, QIDP, Virulence, Toxic megacolon, Diarrhea, CDI, Patient, Clostridioides difficile infection, Perforated ulcer, Collection, GI, Subclinical infection, Centers for Disease Control and Prevention, ISIN, Center, Vomiting, Company, Physiology, Gram-positive bacteria, Blood, Disease, Incidence, Bacteria, Recurrence, Vancomycin, Ileus, Intubation, Heart, Global health, FDA, Pharmaceutical industry, Vaccine, Dietary supplement, Antibiotics, Clostridioides

Preclinical and clinical data show that the prodrug DNV3837 is rapidly converted to DNV3681 in vivo and that the active drug mostly concentrates in the GI tract.

Key Points: 
  • Preclinical and clinical data show that the prodrug DNV3837 is rapidly converted to DNV3681 in vivo and that the active drug mostly concentrates in the GI tract.
  • The diarrhea episodes improved after 6 days of treatment and came back to normal 10 days after treatment after a transient constipation period.
  • Georges Gaudriault, Chief Scientific Officer of DEINOVE who attended the ESCMID/ASM conference in Dublin specifies: The use of DNV3837 is a potential paradigm shift.
  • Located at the heart of the Euromedecine park in Montpellier, DEINOVE has been listed on EURONEXT GROWTH (ALDEI - code ISIN FR0010879056) since 2010.

Tillotts Standardizes on Veeva Commercial Cloud Applications to Power Digital Engagement in Europe

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Mercoledì, Settembre 28, 2022
Cloud, Veeva Systems, NYSE, Clostridioides, Clostridioides difficile infection, Acquisition, Compliance, Industry, Hand, Human, United Kingdom, HCPS, IBD, Marketing, SEC, CDI, Professional corporation, Pharmaceutical industry, Cryptocurrency, Wes Tillott

BARCELONA, Spain, Sept. 28, 2022 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that Tillotts Pharma AG is using Veeva CRM and Veeva Vault PromoMats to advance digital engagement in France, Germany, Italy, Spain, and the United Kingdom. With these connected Veeva Commercial Cloud applications, the company can better coordinate relevant interactions with healthcare professionals (HCPs), delivering tailored and compliant multi-channel content.

Key Points: 
  • With these connected Veeva Commercial Cloud applications, the company can better coordinate relevant interactions with healthcare professionals (HCPs), delivering tailored and compliant multi-channel content.
  • "With Veeva CRM and Veeva Vault PromoMats we gain a complete view of customers and content to enable relevant engagement across Europe," said Adrian Hill, global head of commercial operations at Tillotts.
  • As part of its digital engagement strategy, Tillotts is also using Veeva OpenData , embedding healthcare ecosystem reference data in Veeva CRM for real-time insights.
  • "Tillotts is leading the way toward commercial excellence, creating seamless collaboration between sales, medical, and marketing to better serve its customers," said Philipp Luik, vice president of commercial strategy at Veeva Europe.

Synthetic Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

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Martedì, Settembre 27, 2022
Data, Synthetic biological circuit, Piperacillin/tazobactam, Safety, Meropenem, Clostridioides difficile infection, GI, Infection, Patient, Clinical trial, Form 8-K, Absorption, Washington University School of Medicine, Cohort, Time, IV, Sale, Sepsis, CGMP, Clostridioides, Company, Acquisition, Growth, Washington University School of Law, AES, Annual report, SYN, SEC, HCT, CDI, ECL, NYSE, Risk, Population, VCN, Review, Neoplasm, VRE, SAE, GLOBE, Marketing, Șaeș, Plasma, IAP, Therapy, Cefepime, Washington University in St. Louis, AMR, Private Securities Litigation Reform Act, Maintenance, DSMC, Terminology, Pharmacokinetics, Fever, Degenerative disease, Pharmaceutical industry, Antibiotics

ROCKVILLE, Md., Sept. 27, 2022 (GLOBE NEWSWIRE) -- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the first Cohort of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

Key Points: 
  • A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations including sepsis.
  • None of the three ECL positive plasma samples were found to contain active SYN-004 using a functional enzyme activity assay.
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis.

Astrotech Reports Fiscal Year 2022 Financial Results

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Mercoledì, Settembre 14, 2022
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AUSTIN, Texas, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Astrotech Corporation (Nasdaq: ASTC) (the Company or Astrotech) reported its financial results for the fiscal year ended June 30, 2022.

Key Points: 
  • AUSTIN, Texas, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Astrotech Corporation (Nasdaq: ASTC) (the Company or Astrotech) reported its financial results for the fiscal year ended June 30, 2022.
  • We secured a landmark purchase order from a distributor who services the airport security checkpoint market.
  • Astrotech (Nasdaq: ASTC)is a mass spectrometry company that launches, manages, and commercializes scalable companies based on its innovative core technology through its wholly-owned subsidiaries.
  • Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement.