Encouraging preliminary data from the first part of a clinical study in pouchitis
June 08 2023 - 11:00AM
Encouraging preliminary data from the first part of a clinical
study in pouchitis
8 June 2023
Announcement no. 34
Encouraging
preliminary data from the first part of a clinical study
in pouchitis
- The safety and efficacy of endoscopically administered
gel formulation of Granulocyte Macrophage Colony Stimulating Factor
(GM-CSF) is being evaluated in patients with pouchitis.
- The clinical safety and proof-of-concept study (EudraCT no:
2020-000609-10) assesses the combined treatment with GM-CSF,
fosfomycin and metronidazole for pouchitis in ulcerative colitis
patients after restorative ileal pouch anal anastomosis (IPAA)
surgery.
The study investigates
whether GM-CSF in combination with metronidazole and fosfomycin,
applied topically in the pouch, can be used in patients with
pouchitis. In the first part of the study, a single treatment is
applied topically, under endoscopic supervision to 6 patients. In
the second part of the study involving 12 patients, repeated dosing
will be administered using an enema. The objectives of the study
are to determine safety, and changes in the Pouchitis Disease
Activity Index.
“I am thrilled that we
have been able to show such a strong improvement on pouchitis
symptoms, and objective measures made during endoscopy and
histological evaluation in the first 6 patients in our clinical
study,” says Prof Ismail Gögenur, University of Copenhagen.
“Seeing such a clear effect after a single treatment brings me real
hope that we can develop an effective and safe local treatment for
pouchitis. We observed 5 out of 6 patients with improvement in the
Pouchitis Disease Activity Index (PDAI) total score. It is really
encouraging to see this kind of potent effect in only one treatment
and in that many patients. We are now looking forward to the second
phase of the study to evaluate the effects of repeated daily
treatment.”
"We are very
excited about these preliminary results in the first part of the
study,” says Thomas Kaas Selsø, CEO, “The update from our
investigator gives us optimism for the future development of this
asset."
About
Pouchitis
Total colectomy,
mucosal proctectomy, and ileal pouch-anal anastomosis (IPAA) has
become the surgical procedure of choice for patients with
ulcerative colitis and familial adenomatous polyposis. However,
approximately 50% of patients go on to develop pouchitis (an
inflammation of the ileal remnant). Pouchitis has an estimated
prevalence of 250.000 in the European Union, United States and
Japan. Symptoms of pouchitis include abdominal cramps,
incontinence, bleeding, and tenesmus with considerable impact on
patients’ quality of life. Treatment modalities include oral
antibiotics as well as immunomodulators, steroids, probiotics, and
biological agents, but up to 20% of these patients develop chronic,
treatment-resistant pouchitis, which can result in pouch failure
and the need for reoperation and the possible creation of an
ileostomy.
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early investment in innovative life science companies (in or before
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dedicated to the development of novel, effective treatments for
diseases that have significant patient and social impact.
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