Summary: Cilcare raised €40 million in Series A funding to initiate two Phase 2a clinical trials in 2025 for CIL001, its lead treatment for cochlear synaptopathy, a condition contributing to “hidden hearing loss.”
Takeaways:
- Funding Milestone: Cilcare raised €40 million, including contributions from new investors like SHIONOGI & CO., LTD., to support its ambitious clinical trial plans.
- Pioneering Clinical Trials: Two Phase 2a trials for CIL001 are set to begin in 2025, targeting cochlear synaptopathy in Type 2 diabetes patients and individuals with neurodegenerative disorders.
- Innovative Auditory Research: Leveraging AI and machine learning, Cilcare is advancing biomarker identification and precise auditory data analysis to enhance the success rate of its groundbreaking therapies.
Cilcare, a biotechnology company specializing in auditory sciences, announced the closing of its €40 million (approximately $42 million) Series A funding round, including €21 million raised during the latest round. This funding will enable Cilcare to initiate two Phase 2a clinical trials in 2025 across Europe and the United States for its lead candidate, CIL001, a treatment targeting cochlear synaptopathy.
This fundraising attracted new investors such as SHIONOGI & CO., LTD., Sprim Global Investments Pte. Ltd, along with existing investors like Sofilaro, ARIS, SudPME, and UVM Health Capital.
Treatment for Cochlear Synaptopathy
Cochlear synaptopathy is an underdiagnosed condition and is often referred to as “hidden hearing loss,” because it remains undetectable with standard audiograms, threatens over one billion young people and affects 10-15% of adults. according to Cilcare.
Associated with the early stages of age-related hearing loss, cochlear synaptopathy is exacerbated by noise exposure and results in difficulties understanding speech in noisy environments, tinnitus, and hyperacusis. Patients often report significant fatigue and the need for intense concentration, and without treatment, the condition inevitably progresses to deafness.
Clinical Trials for Auditory Treatments
Currently, Cilcare is the only company focusing on developing therapies for this early-stage auditory pathology, leveraging AI-driven detection methods that have never been explored before, the company says.
The first clinical trial, scheduled for the second half of 2025, will enroll approximately 100 patients with Type 2 diabetes, a population in which Cilcare has identified a high prevalence of cochlear synaptopathy (nearly 40%), particularly among those with elevated glycated hemoglobin levels and over two years of diabetes. Patients will receive a single local administration of CIL001, with auditory function monitored over several months.
The second Phase 2a trial will target patients with neurodegenerative disorders, using a similar treatment protocol for their cochlear synaptopathy.
“This new funding, complemented by strategic agreements such as the exclusive license option signed with Shionogi Ltd. and the support from the France 2030 funds managed by Bpifrance under the Idemo program, represents a decisive milestone in Cilcare’s growth,” says Célia Belline, CEO of Cilcare. “It provides us with the resources to achieve our ambitions, to bring our innovations into clinical trials, closer to patients and healthcare professionals, and to address their needs effectively.”
In recent years, Cilcare has conducted extensive research to identify auditory biomarkers, enabling better patient selection and more precise evaluation of therapies in clinical trials. By integrating advanced auditory data analysis technologies, including artificial intelligence and machine learning, Cilcare has optimized the characterization of auditory function in both preclinical and clinical settings.
Development of CIL001 for Auditory Treatment
These advances significantly increase the success probability of treatments currently in development, particularly CIL001, by targeting high-risk subpopulations for synaptopathy.
At the same time, Cilcare continues to leverage its expertise to support international pharmaceutical companies and researchers in accelerating the development of drugs, gene and cell therapies, and medical devices, the company says.
“This renewed support and international recognition of our expertise and innovations mark a turning point for Cilcare,” says Belline. “Our entire team and partners are driven by a shared mission: to transform auditory healthcare through groundbreaking scientific advancements. We remain steadfast in our commitment to developing or co-developing, alongside strategic partners, disruptive therapeutic solutions for the millions of people affected by auditory disorders worldwide. We will dedicate all our resources, with strength and determination, to this vital mission.”
