BioGaia Pharma announces First Patient Enrolled in Phase I Clinical Study Evaluating BGP014 in mild to moderate ulcerative colitis (AUCH-1).
BioGaia Pharma received formal approval from relevant authorities to proceed with both of its planned clinical trials during summer 2021. Investigational Medical Products were delivered to sites Q4 2021 and screening began. The first patient was enrolled into AUCH-1 in February 2022.
“We are pleased to have taken a significant step in the development of improved therapeutic options in ulcerative colitis treatment,” said Nigel Titford CEO of BioGaia Pharma.
BGP014 is targeted to Ulcerative Colitis (UC). UC is a debilitating condition characterised by chronic inflammation in the intestinal tract affecting roughly 2,5 million patients in Europe and the US alone. There is no cure for UC and patients need life-long treatment prescribed according to the severity of the disease. The primary goal in UC therapy is to induce and maintain remission. First line standard of care is effective for a proportion of patients with few side effects but does not prevent regular flare ups and disease progression in >50% of patients necessitating step-up medication.
The first step in this program is to look at safety, tolerability and preliminary efficacy of BGP014 in the approved Phase I multi-centre study with mild to moderately active UC patients that will take place in Sweden.
More information on the study is available here:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004578-25/SE
https://clinicaltrials.gov/ct2/show/NCT05118919
For additional information please contact:
Nigel Titford, CEO
Phone: +46706313361
E-mail: nigel.titford@biogaiapharma.com
About BioGaia Pharma AB
BGP is a subsidiary to BioGaia AB set up in 2017 to select and develop live microbial based pharmaceutical product candidates to address real medical needs. Candidates are selected based on supporting pre-clinical and clinical research. It has two prioritised programs.
www.biogaiapharma.com
About BioGaia AB
BioGaia is a Swedish world-leading probiotic company that has been at the forefront of microbiome research for more than 30 years. BioGaia develops, markets and sells probiotic products with documented health benefits. To date, over 200 articles on clinical trials with BioGaia's probiotic strains have been published. The products are sold by nutrition and pharmaceutical companies in more than 100 countries. The class B share of the Parent Company BioGaia AB is quoted on the Mid Cap segment of Nasdaq Stockholm.
www.biogaia.com