Eosinophilic esophagitis

Recent Research Supports Sedation-Free TNE for Effective Management of GI Disorders Utilizing the EvoEndo System

Retrieved on: 
Wednesday, April 3, 2024
Health, Medical Devices, Hospitals, Health Technology, Other Health, General Health, Biotechnology, Safety, Anesthesia, TNE, Evaluation, Patient, Pediatrics, Efficacy, Abstract, Male, Workflow, EGD, Eosinophilic esophagitis, Endoscopy, Esophagogastroduodenoscopy, Nursing

Recently published scientific abstracts and peer-reviewed papers support the efficacy and demand for gastroenterology programs to offer Sedation-Free Transnasal Endoscopy (TNE) utilizing the EvoEndo System as an alternative to traditional TNE.

Key Points: 
  • Recently published scientific abstracts and peer-reviewed papers support the efficacy and demand for gastroenterology programs to offer Sedation-Free Transnasal Endoscopy (TNE) utilizing the EvoEndo System as an alternative to traditional TNE.
  • Findings suggest a valuable opportunity to optimize the patient experience, minimize risks associated with anesthesia, and improve diagnostic outcomes.
  • There were no adverse events, suggesting promising potential for TNE as a diagnostic tool in assessing esophageal disorders.
  • These studies highlight the advantages of offering unsedated TNE and the viability of broader applications in pediatric endoscopy.

Equillium Reports on Fourth Quarter and Full Year 2023 Financial Results and Corporate and Clinical Highlights

Retrieved on: 
Monday, March 25, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Itolizumab, Organic acid, Harvard Medical School, Exercise, Alopecia areata, ASN, Partnership, Patient, Gastrointestinal tract, ACR, IL-9, Acquisition, G&A, MPA, Dermatology, Investment, MPH, Therapy, Eosinophilic esophagitis, Retirement, Inflammatory bowel disease, Lupus nephritis, JAK, Pharmaceutical industry

Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights.

Key Points: 
  • Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $9.2 million, compared with $8.5 million for the same period in 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.2 million, compared with $5.2 million for the same period in 2022.
  • Net cash used in operating activities in the fourth quarter was $5.7 million.

Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024
Esophagus, Hercules, Pharmacy, Quarter, Research, Heartburn, DUAL, Regulation, Forecasting, FDA, Pain, Table, PDUFA, Vomiting, Inflammation, GERD, Ratio, PPI, GAAP, Business, Webcast, Enzyme inhibitor, Patient, Express Scripts, Helicobacter pylori, Clinical trial, Vonoprazan/amoxicillin, PBM, G&A, Eosinophilic esophagitis, Tablet, NDA, Prescription, Vonoprazan/amoxicillin/clarithromycin, Pharmaceutical industry

Net loss: Net loss for the fourth quarter 2023 was $79.6 million, compared to $55.0 million for fourth quarter 2022.

Key Points: 
  • Net loss: Net loss for the fourth quarter 2023 was $79.6 million, compared to $55.0 million for fourth quarter 2022.
  • Fourth quarter 2023 net loss included a non-cash charge related to stock-based compensation of $24.6 million compared to $6.7 million for fourth quarter 2022.
  • Phathom will host a conference call and webcast to discuss its fourth quarter and full year 2023 financial results and business highlights today, March 7, 2024, at 8:30 a.m.
  • Phathom believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Phathom's results of operations.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

Home Reintroduction of FPIES Food Triggers May Be Safe and Effective for Children

Retrieved on: 
Tuesday, February 13, 2024
AAAAI, FPIES, Research, Multimedia, Eosinophilic esophagitis, Quality of life, Atopic dermatitis, Immunoglobulin E, Asthma, Drug, Communication, Annual general meeting, NYU, Rhinitis, Milk, Patient, Journal, Food, American Academy

MILWAUKEE, Feb. 13, 2024 /PRNewswire-PRWeb/ -- Home reintroduction of pediatric food protein-Induced enterocolitis syndrome (FPIES) food triggers may be safe for carefully preselected children with food allergies according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, in Washington, DC this month.

Key Points: 
  • MILWAUKEE, Feb. 13, 2024 /PRNewswire-PRWeb/ -- Home reintroduction of pediatric food protein-Induced enterocolitis syndrome (FPIES) food triggers may be safe for carefully preselected children with food allergies according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, in Washington, DC this month.
  • Continued research in this area will enable allergists to make shared decisions with patient families, identifying suitable candidates among children with FPIES for gradual home reintroduction of triggers at appropriate ages.
  • With a median age of 23.5 months, 28 patients attempted reintroduction of FPIES food triggers with 71.5% of reintroduction at home and 28.5% in a medical facility as a formal food challenge.
  • With home reintroduction considered safe for carefully preselected children, children have more treatment options and may have better outcomes and improved quality of life, the research shows.

Revolo Biotherapeutics Receives Orphan Drug Designation from the U.S. FDA for its First-in-Class Peptide as a Potential Treatment for Eosinophilic Esophagitis

Retrieved on: 
Tuesday, January 30, 2024
Principal, Immune system, Eosinophilic esophagitis, Eosinophil, Patient, Safety, Diagnosis, FDA, DSQ, MPH, Food, Autoimmunity, Blood, Disease, Revolo, Flow cytometry, University, ODD, Pharmaceutical industry

Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

Key Points: 
  • Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.
  • A statistically significant reduction in eosinophils, CD4+, and CD8+ cells from baseline as measured in esophageal tissue by flow cytometry.
  • A statistically significant increase in T regulatory cells in esophageal tissue and B regulatory cells in the blood, respectively.
  • The trial will evaluate higher dose levels of ‘1104 and a longer duration of therapy.

Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Thursday, January 25, 2024
Ageing, Regeneron Pharmaceuticals, Patient, Histology, Failure, Diagnosis, Medicine, Heartburn, Risk, Lower respiratory tract infection, Food, Arthralgia, Chronic pain, Safety, Disease, Esophagus, Inflammation, Helminthiasis, Priority review, FDA, Eosinophilic esophagitis, Prevalence, Vomiting, International development, Growth, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Key Points: 
  • Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
  • This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
  • Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies.
  • “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 and older, weighing at least 15 kg.

Press Release: Dupixent® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE)

Retrieved on: 
Thursday, January 25, 2024
Ageing, Patient, Histology, Failure, Diagnosis, Medicine, Heartburn, Risk, Lower respiratory tract infection, Food, Arthralgia, Chronic pain, Safety, Disease, Esophagus, Helminthiasis, FDA, Priority review, Inflammation, Eosinophilic esophagitis, Vomiting, Prevalence, Growth, Pharmaceutical industry

The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
  • Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
  • This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
  • With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 year and older, weighing at least 15 kg.

R&D Day Highlights Kymera’s Immunology Strategy and Emerging Pipeline of Novel, First-in-Class Oral Degraders Addressing Multiple Highly Prevalent Immuno-inflammatory Diseases

Retrieved on: 
Thursday, January 4, 2024
Janus, Atopic dermatitis, Receptor (biochemistry), Sanofi, Janus kinase, Hidradenitis suppurativa, Eosinophilic esophagitis, Autoimmunity, Inflammatory bowel disease, HS, Inflammation, Lupus, Blood, TLR, Therapy, Clinical trial, Asthma, JAK, Dupilumab, Roflumilast, Polyp (medicine), TPD, Webcast, Patient, Psoriasis, TYK2, STAT6, Skin, Sinusitis, Pharmaceutical industry

As part of its strategy, Kymera is unveiling two new programs that each have the potential to address multiple immune-mediated diseases, each with considerable market potential.

Key Points: 
  • As part of its strategy, Kymera is unveiling two new programs that each have the potential to address multiple immune-mediated diseases, each with considerable market potential.
  • Kymera will share its immunology strategy, including market insights, program updates, new preclinical data and development timelines, at its virtual R&D Day this morning.
  • In addition, at low oral doses, KT-621 demonstrated near full in vivo STAT6 degradation and was well-tolerated in multiple preclinical toxicity studies.
  • Kymera will host a webcast to discuss its emerging immunology pipeline from 10:00 a.m. – 12:00 p.m.

EsoCap reports positive topline results from ACESO Phase II trial investigating ESO-101 in eosinophilic esophagitis

Retrieved on: 
Tuesday, December 5, 2023
Patient, Hospital, Dysphagia, Heartburn, Eosinophilic esophagitis, Drinking, Barrett's esophagus, Extrapyramidal system, Conditional sentence, Esophagus, Fungal infection, Eosinophil, Safety, Vomiting, Esophageal cancer, Candidiasis

The ACESO study is a randomized, placebo-controlled, double-blind Phase II study to evaluate the efficacy, tolerability and safety of ESO-101 in patients with active eosinophilic esophagitis (EoE).

Key Points: 
  • The ACESO study is a randomized, placebo-controlled, double-blind Phase II study to evaluate the efficacy, tolerability and safety of ESO-101 in patients with active eosinophilic esophagitis (EoE).
  • "The ACESO study represents an important milestone in the development of our unique application platform for the treatment of esophageal diseases.
  • Following the successful results of this Phase II study, we now plan to initiate a Phase III program in eosinophilic esophagitis,” said Isabelle Racamier, CEO of EsoCap.
  • The detailed results from the ACESO study, including secondary endpoint data, will be submitted for presentation at a future scientific conference.