Chugai Pharma (TYO:4519) and privately-held remote patient monitoring firm Biofourmis are continuing a collaboration to develop digital technologies to objectively measure and manage pain in endometriosis patients.
In endometriosis, the lining of a uterus grows outside the womb. The condition can also affect the ovaries and fallopian tubes. The disease affects approximately 10% of women of reproductive age. Stabbing pelvic pain is a common endometriosis symptom.
In general, physicians have traditionally relied on subjective measures to gauge pain. One common system, for instance, asks patients to rate their pain on a scale from 0 to 10. The Wong-Baker Faces Pain Rating Scale is similar, including pain scales using even numbers but also incorporating smiling and frowning faces.
While such scales are valuable, they are highly subjective, and patients’ personal experience and cultural background can sway their answers.
Chugai and Biofourmis have been collaborating for the past two years to come up with an objective pain measure for endometriosis.
The companies plan to use biosensors and AI algorithms to measure pain. They will validate the results in a global observational study focused on more than 120 participants with endometriosis.
Chugai has an investigational anti-IL-8 recycling antibody to treat endometriosis pain known as AMY109. In developing AMY109, Chugai will make use of Biofourmis’ technology combining remote monitoring with predictive analytics. The technology, based on Biofourmis’ Biovitals analytics engine, was designed to offer digital therapy in conjunction with medication.
Biofourmis’ technology to manage endometriosis-related pain in an outpatient setting will incorporate a clinical-grade wearable biosensor to capture physiological biomarkers. It will also include a companion app with a gamification feature to foster patient engagement and monitor symptoms. In addition, the system will use AI to quantify pain continuously by analyzing physiological biomarkers. It will also feature a web dashboard so clinicians can remotely review the data and intervene if necessary.
Other researchers have explored various techniques to quantify pain using fMRI and EEG, biomarkers and devices that can stimulate the pain response.
In 2020, Chugai and Biofourmis announced their plans to develop an objective assessment of pain based on digital technology.
In their most recent announcement, the two companies said their partnership would focus on the continued development of objective pain measurement related to endometriosis. It also includes continued work on a platform that uses real-world data to measure pain and support patient care. In addition, in the agreement, Biofourmis will also provide virtual specialty care delivery for U.S. endometriosis patients in the U.S. Finally, the most recent partnership encompasses the analysis of data collected during R&D and post-marketing activities of AMY109.
In late February, Chugai announced the publication of a non-clinical study in Science Translational Medicine that showed that AMY109 helped reduce inflammation and fibrosis.