CILcare has achieved a novel milestone by starting patient recruitment in their DIAMANT trial, the first clinical study aiming to deepen knowledge of the link between diabetes and hearing pathologies:
- First observational clinical study conducted at the IDNC (Institute of Diabetology and Nutrition of Centre) in France, in association with the LNA Health research center
- Recruitment of 410 patients with an established diagnosis of type 2 Diabetes Mellitus (T2D), aged between 25 & 70 years old
- Data modeling and analysis using CILcare’s proprietary algorithms will help establish digital auditory signatures, a novel biomarker being developed for the early detection of inflammatory and neurodegenerative diseases.
Montpellier – France – July 3rd, 2023 – CILcare, a biotech specialized in auditory sciences and research and development of novel therapies for inner ear and associated diseases, is announcing the launch of a series of observational clinical trials to define novel auditory biomarkers to prevent neuro-inflammatory diseases and improve patient recruitment in clinical studies.
The accurate and early detection of inflammatory and neurodegenerative diseases offers patients real hope for delaying the onset of initial symptoms. CILcare is here positioning and harnessing its unique expertise in auditory sciences to develop digital auditory signatures, specifically for these pathologies. CILcare is thus launching a series of observational clinical studies to collect auditory data from patients to better characterize the profile of their hearing impairments. The first study, DIAMANT, is being carried out in diabetic patients to deepen our knowledge of the link between diabetes and auditory pathologies, which are highly prevalent in this population.
Diabetes, affecting 530 million people across the world and predicted to reach 783 million by 2045, is a major cause of kidney failure, cardiovascular disorders, neuropathy and retinopathy, altogether significantly impacting the quality of life of patients and their families. Hearing loss is an important complication of diabetes: people living with diabetes are twice as likely to experience hearing impairments, and those with prediabetes have a 30% higher rate of hearing loss than those with normal blood sugar levels.
Although the causal relationship between diabetes and hearing loss is not fully elucidated yet, more and more studies have reported a correlation between the two. It is suspected that systemic inflammation, vascular complications, cochlear microangiopathy, and peripheral neuropathy trigger damage to the inner ear, significantly increasing the risk of hearing loss in these patients.
Due to a number of physiopathological mechanisms leading to cochlear damage, one approach to solve the issue of patient selection in clinical trials is to define subpopulations of patients at risk for hearing loss and suffering from underlying pathologies that are well characterized. With this goal in mind, CILcare is launching a series of observational clinical trials. In the case of the DIAMANT study, the generated results will allow to characterize hearing deficiencies of patients with type 2 diabetes to better monitor and treat them.
About DIAMANT study
The enrolment of 410 patients with type 2 Diabetes Mellitus (T2D), aged between 25 & 70 years old is planned for this observational monocentric, cross-sectional Phase 0 study.
The primary endpoint of the study is to define the prevalence of sensorineural hearing loss in T2D patients. Key secondary endpoints include prevalence of other forms of sensorineural hearing loss such as speech recognition, auditory neuropathy, otoacoustic emissions, and acoustic reflex thresholds. There will be a clear focus on cochlear synaptopathy, which corresponds to difficulty in understanding in a noisy environment and is the first sign of hearing loss.
Correlations will be examined between auditory read-outs and biochemical parameters such as glycemia (HbA1c), dyslipidemia, kidney functions, and inflammation.
“We are excited to have enrolled the first patients in our DIAMANT study”, exclaims Mathieu Schue, Director of Clinical Sciences and Operations at CILcare. “The initiation of this clinical trial is an important step at CILcare, and more broadly, in hearing research. It is still poorly known that type 2 diabetes is a risk factor for hearing loss, both among patients and healthcare professionals, but more and more studies point to a link between both conditions. This study will allow us to collect robust and exhaustive real-world data from a large cohort of type 2 diabetic patients to define and fully characterize their auditory profiles using a complete set of standardized audiological tests. We will thus be able to identify potential risk factors linked to hearing loss such as diabetes history, glycemic control, dyslipidemia, anti-diabetic drugs, associated with these hearing profiles. More significantly, we believe it will help raise awareness of this insidious comorbidity of type 2 diabetes and the importance of clinical auditory monitoring guidelines in diabetes management.”
The DIAMANT study is expected to be completed by 2024. The results will be used to refine the phase Ib/IIa clinical study protocols planned from 2024 with CIL001, CILcare’s lead candidate for the treatment of synaptopathy, which corresponds to difficulty in understanding speech in noise, affects one in four people from 45 years old, and threatens more than a billion young people.
“The challenge of the observational studies conducted by CILCARE is to identify auditory biomarkers and to highlight the subpopulations of patients who present synaptopathy and who could participate in our clinical trials. They are an inseparable building block of our clinical development, not only for treating the right patients at the right time with the right treatment, but also by providing additional evidence of the effectiveness of our drugs within objective markers that Health authorities are today more favorable to evaluate. This precise characterization of auditory functionality and correlations with markers of neurocognitive and inflammatory pathologies has never been carried out before. It is crucial to advance Auditory Sciences and all therapies that will enable us to preserve this sense, which is essential to life, for as long as possible” adds Celia BELLINE, CEO of CILcare.
About CILcare: CILcare is a biotechnology company harnessing auditory sciences
for the early definition, detection and treatment of synaptopathy in neurocognitive and inflammatory diseases. Located in Montpellier and the Boston area (USA), CILcare develops its own portfolio of drug candidates using its next-generation AI (Artificial Intelligence) and RWD (Real-World Data) platform, relying on a unique expertise in preclinical development and on the ability to translate generated data into a clinical development strategy.
CILCARE has also been a catalyzer in accelerating drug development in hearing disorders since 2014 by providing its smart R&D platform as a research-for-hire to some of the top hearing research companies and academic institutions in US, Europe and Asia.