Delving into the Latest Updates on Fcgamma1-Fel d1 human-cat fusion protein vaccine (Tunitas Therapeutics) with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

GFD

Target

CD23

Action

antagonists

Mechanism

CD23 antagonists(Immunoglobulin epsilon Fc receptor antagonists)

Therapeutic Areas

Immune System Diseases

Active Indication-

Inactive Indication

Hypersensitivity

Originator Organization

University of California

Active Organization-

Inactive Organization

Tunitas Therapeutics, Inc.

University of California

Drug Highest PhasePendingClinical

First Approval Date-

Regulation-

The correlation between clinical, serological, and endoscopic findings and histological response after a gluten-free diet (GFD) is limited in adult celiac (CD) patients. This study aims to evaluate the effects of GFD on intraepithelial lymphocyte (IEL) localization by comparing the histopathological, clinical, serological, and endoscopic findings of adult CD patients. The patients (n = 131) were divided into three groups: those with good (CDgc) (n = 23) and poor (CDpc) (n = 21) GFD compliance and newly diagnosed ones (nCD) (n = 87). Total and supranuclear IELs were counted per 100 enterocytes and divided into three groups: apical, mixed, and basal, according to ROC (Receiver operating characteristic) analysis. The roles of clinicopathological parameters in predicting good dietary compliance were calculated using the multivariable logistic regression model. CDgc group predominantly (78.3 %) exhibited a basal pattern, and none exhibited an apical. Conversely, most CDpc and nCD patients showed mixed (66.7 % and 73.6 %, respectively) and apical (9.5 % and 25.3 %) patterns. Non-atrophic Marsh types (p = 0.040) and basal pattern (p = 0.043) were independent parameters predicting good dietary compliance. This study first showed that IEL localizations can indicate GFD compliance in samples from CD patients. Localization-based examination of IELs can be an additional histological indicator in monitoring GFD compliance and signs of recovery, especially in adult CD patients.

01 Feb 2025·Arab Journal of Gastroenterology

Short-term effect of gluten-free diet on disease severity, quality of life, and inflammatory markers among patients with mild to moderate ulcerative colitis: A triple-blind randomized placebo-controlled trial

Article

Author: Ebrahimi Daryani, Naser ; Aletaha, Najmeh ; Rezaee-Zavareh, Mohammad Saeid ; Hadi, Reza ; Hesabgar, Nazanin ; Alborzi Avanaki, Foroogh

BACKGROUND AND STUDY AIMS:

Diet is an important underlying factor in ulcerative colitis (UC) disease. The present study aimed to investigate the effect of a gluten-free diet (GFD) on disease severity, quality of life, and inflammatory markers in patients with UC.

PATIENTS AND METHODS:

In this triple-blind randomized placebo-controlled clinical trial, we evaluated the effect of a GFD on the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, disease severity, and quality of life in patients with mild to moderate UC. Patients' quality of life and severity of symptoms were evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ) and Simple Clinical Colitis Activity Index (SCCAI), respectively. Patients received this regimen for six weeks and were evaluated before and after the intervention.

RESULTS:

The mean age of patients (n = 26) was 39.31 years (standard deviation = 9.34). In both study groups, the mean ESR, CRP, IBDQ, and SCCAI showed no statistically significant improvement with the dietary intervention. Fecal calprotectin was increased in both groups without statistical significance.

CONCLUSIONS:

We could not find any significant effect of GFD on inflammatory markers, quality of life, and disease severity among patients with mild to moderate UC. It is too early to suggest the gluten-free diet as a safe and beneficial regimen for UC patients. There is a need for further investigations with larger sample sizes and longer follow-ups as clinical trials and cohort studies to obtain more reliable results.

01 Jan 2025·JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY

Prevalence and etiologies of non‐responsive celiac disease: A systematic review and meta‐analysis

Review

Author: Bhatia, Unnati ; Makharia, Govind K ; Aggarwal, Nishant ; Ahuja, Vineet ; Singh, Achintya Dinesh ; Singh, Prashant ; Dwarakanathan, Vignesh

Abstract:

Background and Aim:

Non‐responsive celiac disease (NRCD) is defined as ongoing symptoms despite 6–12 months of gluten‐free diet (GFD), the only known treatment for celiac disease (CeD). There is inconsistency in studies describing the proportion of patients having NRCD and its various causes among patients with CeD. We therefore conducted a systematic review and meta‐analysis to determine the prevalence and causes of NRCD.

Methods:

The PubMed, Embase, Cochrane Library, Scopus, and Web of Science databases were searched for original studies reporting the proportion of patients with persistent symptoms after ≥ 6 months of GFD. Studies reporting the etiologies of NRCD were also identified. The systematic review was conducted as per the Meta‐analysis of Observational Studies in Epidemiology guidelines. Statistical analysis was performed in STATA.

Results:

Of 2965 search results, nine studies met the inclusion and exclusion criteria. Five studies (n = 4414) reported data on prevalence, and seven studies (n = 790) reported the causes of NRCD. The pooled prevalence of NRCD was 22% (95% confidence interval, 11–35%). Among patients with NRCD, inadvertent exposure to gluten was the most common cause (33%), followed by functional gastrointestinal disorders including irritable bowel syndrome in 16%. Refractory CeD type II along with its premalignant and malignant sequelae was observed in 7% of patients with NRCD.

Conclusion:

One in five patients with CeD may not respond to GFD and would likely be classified as NRCD. Inadvertent gluten exposure was the cause of ongoing symptoms in one‐third of patients with NRCD. Improving adherence to GFD along with developing novel therapeutics to mitigate symptoms due to ongoing gluten exposure is critical.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypersensitivity	Clinical	Australia	Tunitas Therapeutics, Inc.	-

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