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Agomab Therapeutics is conducting the STENOVA study, which offers hope to individuals dealing with fibrostenotic Crohn’s disease. The project focuses on AGMB-129, an oral capsule designed to target scar tissue in the intestines, aiming to alleviate symptoms, enhance patients’ quality of life, and potentially reduce the need for surgery.


New Hope for Fibrostenotic Crohn’s Disease Patients: The STENOVA AGMB-129-C102 Study
If you or someone you know has been living with fibrostenotic or stricturing Crohn’s disease, you’re likely aware of the challenges it poses: the pain after eating, frequent diet modifications and the concern of maintaining body weight, intestinal blockages, cramping, and ultimately the need to undergo surgery. Moreover, the absence of any treatment option makes life even more difficult. However, there’s promising news on the horizon - the STENOVA study by Agomab Therapeutics is testing a possible first new treatment for the fibrostenotic Crohn’s disease community.

Fibrostenotic Crohn’s disease is characterised by the formation of scar tissue (fibrosis) in the intestines, leading to narrowing and blockages. AGMB-129 is an oral capsule designed to treat this scar tissue locally in the gut with the aim to alleviate symptoms, improve patients’ quality of life, and potentially reduce the need for surgery over time. This first study in patients will assess the safety of AGMB-129, study what the body does to drug (pharmacokinetics) and evaluate what the drug does to your body and associated disease (pharmacodynamics). Moreover, initial effectiveness of the drug will be assessed by monitoring symptoms improvement over the treatment duration.

In this carefully designed clinical trial, participants will be randomly assigned to receive either AMGB-129 or a placebo (an inactive substance). 2 out of 3 participants will receive AGMB-129 and 1 out of 3 will receive a placebo. This double-blind approach ensures that neither the patients nor the researchers know who is receiving the actual treatment until the study has been completed, reducing bias on its evaluation. Patients are allowed to continue their current IBD treatment throughout the trial. The safety and activity of AGMB-129 will be compared against placebo over the 12-week treatment period.

Recruitment Criteria
To participate in the study, candidate patients must have a confirmed diagnosis of fibrostenotic Crohn’s disease and meet specific eligibility criteria. The recruitment process will be conducted at multiple medical centres in the EU, US, and Canada.

Benefits to the IBD Community
The STENOVA AGMB-129-C102 study holds significant potential benefits for the IBD community, especially those suffering from fibrostenotic Crohn’s disease. If the investigational treatment proves successful, it could lead to:
•    Improved Quality of Life: Patients may experience reduced symptoms, less pain, and fewer intestinal blockages, allowing for a better overall quality of life.
•    Reduced Surgery: If the treatment can prevent or delay the progression of fibrosis, it may eventually decrease the need for surgical intervention, which is the last resort for too patients.
•    New Treatment Options: This study represents a step forward in the development of targeted therapies for fibrostenotic Crohn’s disease, offering hope for individuals who have exhausted existing treatment options.

The STENOVA AGMB-129-C102 study from Agomab Therapeutics is a ray of hope for individuals living with fibrostenotic Crohn’s disease. Through rigorous research and clinical trials, this program aims to bring a potentially life-changing treatment to the IBD community. While there are no guarantees in clinical research, the STENOVA study may provide important clinical benefits in patients with this difficult to treat disease. If you or someone you know is eligible, consider participating in this study to contribute to the advancement of Crohn’s disease treatment options.

Project date: 
September, 2023