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Cyclana Bio, a biotechnology company pioneering tissue-level approaches to women’s health, today announced it has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its 500-patient clinical observational study, PEMP (Predicting Endometriosis Mechanisms and Populations). The first patients to take part in the study have been recruited at Peterborough City Hospital, with the Rosie Hospital, Cambridge recently also starting recruitment.
Prof. Kevin Chalut, Dr. Léa Wenger, Dr. Siiri Salomaa and Dr. Tom Wyatt in their labs at Babraham. Image Credit: Cyclana BioThe PEMP study aims to improve the understanding of the disease physiology of endometriosis, a condition that affects 1 in 10 women, yet has limited available treatments due to a lack of available data and disease models. Cyclana Bio will use human data and cells collected from both biopsies and menstrual fluid donated by participants in the study to build physiologically relevant in vitro 3D models of the disease. These models will help uncover the basic biology and support the identification and prioritization of novel druggable targets for therapeutic development. The Company also aims to develop tools to better stratify patients based on clinical need, highlighting not just endometriosis but the differences in the disease.
To establish a better understanding of the mechanisms of the disease, Cyclana Bio will compare the tissue level dynamics in healthy women to those with endometriosis. Having previously confirmed the involvement of the extracellular matrix (ECM) in the manifestation of the disease, data from the study will also reveal whether endometriosis has a common underlying causal mechanism for which a single treatment can be developed, or whether a personalized medicine approach is needed.
Conducted by the Cambridge University Hospitals NHS Foundation Trust and the North West Anglia NHS Foundation Trust, the study is being led by Chief Investigator M. Saikat Banerjee at the Rosie Hospital alongside Peterborough City Hospital site Principle Investigator M. Lukasz Polanski and Cambridge site Investigator Dr. Norman Shreeve.
“Our ultimate goal is to address a need to better serve millions of women suffering with a debilitating condition and develop life-changing therapies. We are excited for the pace and flexibility permitted by doing deep scientific research within the start-up model which will hopefully get us to better solutions faster. The HRA approval and recruitment of the first patients in the PEMP trial mark key milestones in our journey towards this goal. I’d like to thank the research staff in both NHS sites, who have been pivotal in getting this set up,” said Dr. Léa Wenger, CEO and Co-Founder of Cyclana Bio. “Our tissue-first methodology represents a promising alternative approach in drug discovery, allowing us to reveal shared underlying mechanisms between patients, closing the gap on drug discovery programs focusing on intracellular mechanisms that have failed to generate optimal treatments.”
Endometriosis is sadly a common condition and yet we know so little, and as a result women’s suffering is further prolonged and treatments remain out of reach. With the use of the latest tools in molecular phenotyping and genomics, together with Cyclana Bio we are focused on correcting this problem through this observational study.”
M. Saikat Banerjee, Chief Investigator, Rosie Hospital, Cambridge
M. Lukasz Polanski, Principal Investigator at Peterborough City Hospital, added: “Enrolling the first participant is a key milestone in this vital clinical study that will help uncover causal mechanisms of endometriosis - a condition where a better understanding is so desperately needed to direct drug development research and help millions of women struggling with this progressive disease that can affect every stage of their life.”
The 500-patient study is being funded by Cyclana Bio’s £5 M pre-seed funding round, which closed last year. The Company will use future financings to recruit additional study sites and expand its whole tissue-based methodology to other underserved chronic inflammatory indications with similar tissue-level mechanisms.
