Cyclana Bio Launches 500-Patient Study to Decode Endometriosis Mechanisms Using Novel Tissue-Based Approach
核心洞察
Cyclana Bio (搜索) received Health Research Authority approval for its 500-patient PEMP observational study investigating endometriosis (搜索) mechanisms affecting 1 in 10 women.
The company will use human tissue and menstrual fluid samples to build 3D disease models and identify novel druggable targets for therapeutic development.
The study aims to determine whether endometriosis (搜索) requires a single treatment approach or personalized medicine based on tissue-level dynamics and extracellular matrix (搜索) involvement.
Cyclana Bio (搜索) has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its ambitious 500-patient clinical observational study targeting endometriosis (搜索), a condition affecting 1 in 10 women worldwide. The PEMP (Predicting Endometriosis Mechanisms and Populations) study represents a novel tissue-first approach to understanding a disease that has historically lacked adequate treatment options due to limited available data and disease models.
The first patients have been recruited at Peterborough City Hospital (搜索), with the Rosie Hospital in Cambridge also beginning enrollment. The biotechnology company plans to use human data and cells collected from both biopsies and menstrual fluid donated by study participants to build physiologically relevant in vitro 3D models of endometriosis (搜索).
Innovative Tissue-Based Drug Discovery Platform
Cyclana Bio (搜索)'s methodology focuses on tissue-level dynamics rather than traditional intracellular mechanisms, which the company argues have failed to generate optimal treatments for endometriosis (搜索). The study will compare tissue-level dynamics in healthy women to those with endometriosis, building on the company's previous confirmation of extracellular matrix (搜索) (ECM) involvement in disease manifestation.
"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," said Dr. Léa Wenger, CEO and Co-Founder of Cyclana Bio (搜索).
The 3D disease models developed from participant samples will help uncover basic biology and support identification and prioritization of novel druggable targets for therapeutic development. Additionally, the company aims to develop tools for better patient stratification based on clinical need, highlighting differences within the disease itself.
Addressing Critical Knowledge Gaps
The study seeks to answer a fundamental question about endometriosis (搜索) treatment strategy: whether the condition has a common underlying causal mechanism suitable for a single treatment approach, or whether a personalized medicine strategy is necessary. This determination could significantly impact future therapeutic development directions.
"Endometriosis (搜索) 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," said M. Saikat Banerjee, Chief Investigator at the Rosie Hospital, Cambridge. "With the use of the latest tools in molecular phenotyping and genomics, together with Cyclana Bio (搜索) we are focused on correcting this problem through this observational study."
Multi-Site Clinical Implementation
The study is being conducted by Cambridge University Hospitals NHS Foundation Trust and North West Anglia NHS Foundation Trust (搜索). The research team includes Chief Investigator M. Saikat Banerjee at the Rosie Hospital, Principal Investigator M. Lukasz Polanski at Peterborough City Hospital (搜索), and Cambridge site Investigator Dr. Norman Shreeve.
M. Lukasz Polanski emphasized the study's significance, stating: "Enrolling the first participant is a key milestone in this vital clinical study that will help uncover causal mechanisms of endometriosis (搜索)—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."
Funding and Future Expansion
The 500-patient study is funded by Cyclana Bio (搜索)'s £5M pre-seed funding round, which closed last year. The company plans to use future financing to recruit additional study sites and expand its tissue-based methodology to other underserved chronic inflammatory indications with similar tissue-level mechanisms.
Dr. Wenger highlighted the company's mission: "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."