02/12/2024
Mikrobiomik in association with IRYCIS (Instituto Ramón y Cajal de Investigación Sanitaria) are launching the DIREBIOT clinical trial, following the recent authorization by the Spanish Agency for Medicines and Health Products (AEMPS).
It is a phase IIa clinical trial to evaluate the efficacy, safety, tolerability, and dosage of MBK-01 in the treatment of recurrent diverticulitis, which affects around 30% of people aged 40-60 and 50-70% of those over 80.
The presence of pouch-like dilatations – or diverticula – mainly in the colon significantly affects patients’ quality of life. Symptoms include abdominal pain or bloating, increased frequency of bowel movements, abscesses, obstruction, fistulas, hemorrhages and even peritonitis in the most severe cases. Changes in diet and lifestyle habits are leading to an increase in its prevalence.
DIREBIOT is an open-label, randomized, controlled trial with three treatment groups – including a control one – involving 81 patients diagnosed with recurrent diverticulitis with at least three episodes of acute diverticulitis in the last three years. The main efficacy endpoint will be the number of new episodes of acute diverticulitis occurring during the trial.
The DIREBIOT project is part of the collaboration agreement signed at the end of 2022 between Mikrobiomik and IRYCIS to join forces in the research and co-development of therapeutic innovations related to the microbiome. This is the second study authorized for Mikrobiomik by the AEMPS in the last four years, leading the development of biological medicines based on intestinal microbiota.
Sources:
[1] Talutis, S.D., Kuhnen, F.A.H. (2021). Pathophysiology and Epidemiology of Diverticular Disease. Clin Colon Rectal Surg., 34(2):81-85. doi: 10.1055/s-0040-1716698.
[2] Tursi, A. (2018). A critical appraisal of advances in the diagnosis of diverticular disease. Expert Rev Gastroenterol Hepatol., 12(8):791-796. doi: 10.1080/17474124.2018.1487288.
Tursi, A., Scarpignato, C., Strate, L.L., Lanas, A., Kruis, W., Lahat, A., Danese, S. (2020). Colonic diverticular disease. Nat Rev Dis Primers., 6(1):20. doi: 10.1038/s41572-020-0153-5.
