Navarra – May 10, 2023 – Medibiofarma S.L., a clinical-stage biotechnology company developing a
portfolio of new therapies for the treatment of gastrointestinal (GI) diseases as well as other
cancer and non-cancer diseases announced the first patient dosed in the Phase II clinical trial of
MBF-118 in patients with Crohn’s disease.
MBF-118 has previously completed pre-clinical development and a phase I trial which
demonstrated the excellent safety and tolerability of the compound. MBF-118 is a patented new
chemical entity which acts as a partial agonist of PPAR and has both anti-fibrotic and anti-
inflammatory properties. It is GI-enriched in PK studies in humans, with excellent tolerability and
efficacy in animal models of fibrosis and colitis. The current single-centre phase II trial will be
carried out at the Hospital complex of the University of Santiago de Compostela (CHUS), Galicia,
Spain, under the supervision of Dr. Manuel Barreiro. Dr. Barreiro is an Associate Professor of
Digestive Medicine at the University of Santiago, and also the President of the Spanish Crohn’s
and Colitis workgroup (GETECCU).
Richard Roberts, CSO of Medibiofarma said, “While the inflammatory component of Crohn’s
disease is well managed with existing therapies, fibrosis and its accompanying stenosis has no
treatment, even after surgical removal of the diseased section of intestine. It’s taken us seven
years, pandemic included, from our first steps in the lab to reach this decisive moment – when we
can finally dose our first patients and evaluate initial clinical efficacy.”
MBF-118 is the front runner compound of Medibiofarma’s clinical portfolio which also includes
novel therapies for cognitive impairment diseases and solid tumours.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn’s disease, is
estimated to affect 3 million people in the United States, with as many as 70,000 new cases
diagnosed each year. While the causes of ulcerative colitis and Crohn’s disease are not entirely
understood, both are associated with chronic inflammation in the gastrointestinal tract, with
symptoms that include abdominal pain, increased stool frequency, diarrhoea, rectal bleeding, and
fatigue. Currently available medications alleviate inflammation and reduce symptoms, but do not
provide a cure or prevent long-term complications, and some have severe adverse effects,
including increased risk of infection and malignancy. Thus, there continues to be a high unmet
medical need for additional oral agents that are safe and effective for the induction and
maintenance of remission of ulcerative colitis and Crohn’s disease.