Acid erosion

New Analyses of the MIRROR Randomized Controlled Trial in Uncontrolled Gout Presented at the 2023 EULAR European Congress of Rheumatology

Retrieved on: 
Wednesday, May 31, 2023

Presentations are part of expert discussions at the EULAR European Congress of Rheumatology , May 31 - June 3, 2023, in Milan.

Key Points: 
  • Presentations are part of expert discussions at the EULAR European Congress of Rheumatology , May 31 - June 3, 2023, in Milan.
  • Data presented from Horizon’s MIRROR randomized controlled trial (RCT), which evaluated KRYSTEXXA in combination with methotrexate for uncontrolled gout, provide further evidence of the impact of therapy on patient-reported outcomes (PROs), urate depletion and bone remodeling.
  • “Uncontrolled gout is far more painful and dangerous than most people know,” said Brian LaMoreaux, M.D., M.S., senior medical director, Horizon.
  • Bone erosion remodeling after depletion of monosodium urate deposition with intensive urate-lowering with pegloticase in patients with uncontrolled gout: MIRROR RCT dual-energy CT findings (POS0514)

Clario, GI Reviewers and RSIP Vision Team Up to Present a New AI Solution to Advance Clinical Trials for Inflammatory Bowel Diseases

Retrieved on: 
Monday, March 6, 2023

PHILADELPHIA and COPENHAGEN, Denmark and SAN MATEO, Calif. and BOSTON and JERUSALEM, March 6, 2023 /PRNewswire/ -- Clario, a leading healthcare research and technology company that generates the richest clinical evidence for the clinical trials industry and GI Reviewers, LLC Gastroenterology consultants and central readers, together with RSIP Vision, an experienced developer of groundbreaking AI technologies for medical imaging, today announced their new AI-based scoring system for inflammatory bowel diseases. The solution is expected to improve the reproducibility of colonoscopy video scoring, optimize workflow by shortening the time required for a human expert reader to score, and ultimately improve recruitment and reduce costs associated with clinical trials. Peer-reviewed results demonstrating the human-level performance of this innovative system were presented to the pharmaceutical and clinical trials industry community at the prestigious European Crohn's and Colitis (ECCO) conference this week.

Key Points: 
  • Innovative, human-level AI technology will improve efficiency and consistency of Inflammatory Bowel Disease (IBD) scoring, advancing clinical trials of novel treatments for these debilitating ailments.
  • Inflammatory bowel diseases (IBD) such as Ulcerative Colitis (UC) and Crohn's disease are mostly diagnosed by performing a colonoscopy.
  • Algorithm performance, as assessed by the Kappa metric, was found to be comparable to the performance of human reviewers.
  • Clario, GI Reviewers, and RSIP Vision continue to collaborate to bring the benefits of AI to all aspects of IBD clinical trials.

BridgeBio Pharma Affiliate Phoenix Tissue Repair Announces Positive Results from Phase 2 Trial of PTR-01, a Protein Replacement Therapy for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Retrieved on: 
Friday, May 20, 2022

PALO ALTO, Calif., May 20, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate company Phoenix Tissue Repair, which is focused on advancing a novel systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB), announced data from the Phase 2 trial of PTR-01, an intravenously-administered recombinant collagen 7 (rC7) protein replacement therapy, in patients with recessive dystrophic epidermolysis bullosa (RDEB). The data are being shared in a poster at the Society for Investigative Dermatology (SID) Annual Meeting 2022 between May 18 – 21, 2022 in Portland, Oregon.

Key Points: 
  • Our data shows that treatment with PTR-01 led to rapid, consistent, and durable wound healing, said Sanuj K. Ravindran, M.D., executive chairman of Phoenix Tissue Repair.
  • Phoenix Tissue Repair is an affiliate company of BridgeBio and focused on advancing a novel systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB).
  • PTR-01 is an investigational protein replacement therapy which uses a recombinant collagen type VII (rC7) for the treatment of RDEB.
  • Moreover, BridgeBio and Phoenix Tissue Repair operate in very competitive and rapidly changing environments in which new risks emerge from time to time.

New Data Presented at DDW 2022 Shows Nearly Two-Fold Risk of Loss of Remission in Ulcerative Colitis Patients who had Histologic Inflammation on Baseline Biopsy

Retrieved on: 
Sunday, May 22, 2022

Target RWE's IBD study & real world data presented at DDW 2022 included more than 500 patients with Ulcerative Colitis.

Key Points: 
  • Target RWE's IBD study & real world data presented at DDW 2022 included more than 500 patients with Ulcerative Colitis.
  • The study found that among patients in endoscopic remission, histologic inflammation was associated with a two-fold increased risk of subsequent LOR.
  • "We sought to uncover factors predictive of relapse and found histologic inflammation despite endoscopic remission to be an important risk factor for subsequent LOR.
  • Future research should focus on determining if treatment modification or intensification may be effective at preventing LOR in certain patients."

Xeris Biopharma Announces Gvoke® Kit Is Now Available for the Treatment of Severe Hypoglycemia in Adults and Children With Diabetes Ages 2 And Above

Retrieved on: 
Wednesday, March 16, 2022

Gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.

Key Points: 
  • Gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.
  • In August 2021, the FDA approved Gvoke Kit, the first ready-to-use glucagon available in a single-use vial and single-use syringe kit for rescue.
  • GVOKE is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above.
  • GVOKE is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above.

Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis

Retrieved on: 
Monday, March 14, 2022

Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S.

Key Points: 
  • Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S.
  • We believe there is great interest among patients and healthcare providers for new treatment options to address the shortcomings of current treatment.
  • If approved, vonoprazan has the potential to satisfy the large unmet needs of millions of patients and set a new treatment paradigm in EE.
  • Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.

Researchers Present Global Effort to Develop Machine Learning Tools for Automated Assessment of Radiographic Damage in Rheumatoid Arthritis

Retrieved on: 
Saturday, November 6, 2021

This includes both joint space narrowing (which indicates cartilage loss) and bone erosions (which indicates damage from invasion of the inflamed joint lining).

Key Points: 
  • This includes both joint space narrowing (which indicates cartilage loss) and bone erosions (which indicates damage from invasion of the inflamed joint lining).
  • "For example, researchers could analyze data from electronic health records and from genetic and other research assays to find biomarkers associated with progressive damage.
  • Having to score all the images by visual inspection ourselves would be tedious, and outsourcing it is cost prohibitive."
  • Additional sets of images were then provided so the competitors could test and refine the tools they had developed.

Eurecon Verlag: Pharma Trend Awards Best Pharmaceutical Companies and the Most Innovative Products 2021

Retrieved on: 
Thursday, September 30, 2021

In addition to the company's research activity, a large product pipeline with many innovations is decisive for the award, as well as the quality of the products.

Key Points: 
  • In addition to the company's research activity, a large product pipeline with many innovations is decisive for the award, as well as the quality of the products.
  • The ranking "Best Pharmaceutical Companies Germany 2021" was also published: Roche Pharma, Lilly, Bristol-Myers Squibb, Novartis Pharma and Amgen occupy places one to five in the Pharma Trend Image & Innovation Award survey.
  • Thirteen other winners were able to enjoy the award "Most Innovative Product".
  • The app MyIUS from Jenapharm, which accompanies users of intrauterine systems, was chosen in the Digital Health Applications category.

Phathom Pharmaceuticals Announces Results from VONO-103, a Phase 1 Study Evaluating Gastric Acid Inhibition of Vonoprazan and Lansoprazole (PREVACID®)

Retrieved on: 
Monday, September 27, 2021

FLORHAM PARK, N.J., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported results from VONO-103, a Phase 1 trial evaluating the effects of vonoprazan 20 mg once daily (“QD”) and lansoprazole 30 mg QD in healthy U.S. subjects. In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole. The study treatments were generally well tolerated with no serious adverse events reported.

Key Points: 
  • In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole.
  • The greater gastric acid inhibition was maintained after seven days of once daily dosing.
  • The mean 24-hour pH value on Day 7 for vonoprazan was 5.9 as compared to 3.8 for lansoprazole (p
  • VONO-103 is the first pharmacokinetic and pharmacodynamic (PK/PD) and safety study comparing vonoprazan 20 mg QD and lansoprazole 30 mg QD.

Cinclus Pharma announces the first patient randomized in the Phase II study for X842 in GERD

Retrieved on: 
Wednesday, August 18, 2021

Cinclus Pharma AB is a clinical stage pharma company developing small molecules for the treatment of gastric acid related diseases.

Key Points: 
  • Cinclus Pharma AB is a clinical stage pharma company developing small molecules for the treatment of gastric acid related diseases.
  • The beneficial safety and pharmacokinetic properties of X842 have been documented in phase I studies.
  • The Phase 2 study is ongoing in Europe and the US.
  • Linaprazan has been evaluated in 23 phase I, and two phase II studies in a total of approximately 2,500 subjects.