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 OIC-1 in January 2022.
BGP345A looks to treat constipation in patients receiving opioid therapy for prescribed pain treatment. Opioids are an essential option for chronic pain, primarily back pain, rheumatism or post-operative pain, where non-opioid multimodal drugs or physical therapy are not providing relief. Opioid use can lead to a number of side effects with Opioid-Induced Constipation (OIC) being the most common with a varying prevalance of 41-81%. Current first line therapy is the use of laxatives but at least 45% of patients are laxative refractory and continue to have motility issues. The approved study is a Phase II multi-centre study to assess the safety and preliminary efficacy of BGP345A and will take place in France.
“We believe that BGP345A has potential to provide a novel and effective approach to restoring gut motility where treatment is currently suboptimal. The initiation of patient enrolment is an important step in our development and confirms our commitment to develop novel live-microbial based solutions in areas of medical need.” says Nigel Titford CEO of BioGaia Pharma.
More information on the study is available here:
For additional information please contact:
Nigel Titford, CEO
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.
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.