Osaka-based pharmaceutical company Shionogi & Co., Ltd. has announced a new joint research agreement with French biotechnology firm Cilcare SAS to develop innovative treatments for hearing loss, building on their existing partnership that could be worth up to €400 million.
The collaboration aims to create a new drug pipeline targeting hearing loss, a condition affecting approximately 5% of the world's population, including 432 million adults and 34 million children. By 2050, experts predict that one-quarter of the global population will experience some degree of hearing impairment.
Addressing a Critical Unmet Medical Need
Hearing loss represents a significant global health challenge with far-reaching implications. Beyond the immediate impact on quality of life, hearing impairment has been identified as a risk factor for dementia development. Recent research published in The Lancet suggests that addressing hearing loss could potentially reduce dementia risk.
Despite its prevalence and serious consequences, there are currently no effective pharmacological treatments for hearing loss, highlighting a substantial unmet medical need. The economic burden is equally significant, with unaddressed hearing loss estimated to cost approximately $1 trillion annually worldwide.
Dr. Isao Teshirogi, CEO of Shionogi, emphasized the company's commitment to addressing this gap: "We are dedicated to creating innovative solutions for conditions with high unmet needs. This collaboration with Cilcare represents an important step toward developing effective treatments for the millions affected by hearing loss globally."
Leveraging Complementary Expertise
The new agreement will integrate Shionogi's established drug discovery capabilities with Cilcare's specialized knowledge in auditory science. Founded in 2014, Cilcare has developed cutting-edge solutions for characterizing, diagnosing, and treating hearing impairments and related disorders.
A key advantage of the partnership is access to Cilcare's non-clinical evaluation technology, which is expected to expedite research and advance product development from early stages. The collaboration will also leverage Cilcare's clinical trial data to enhance translational research capabilities in the hearing loss field.
Celia Belline, CEO of Cilcare, stated: "By combining our decade of specialized experience in auditory science with Shionogi's pharmaceutical development expertise, we are well-positioned to accelerate the development of breakthrough therapies for hearing loss patients worldwide."
Building on Previous Agreements
This new research collaboration builds upon an existing option agreement between the two companies. Under that arrangement, Shionogi made an upfront payment of €15 million to Cilcare for the option to acquire exclusive licenses for the development, manufacturing, and commercialization of two hearing loss treatment candidates, CIL001 and CIL003.
If Shionogi exercises its options for both compounds and successfully develops and commercializes them, the total payments—including option fees and development, regulatory, and sales milestones—could reach approximately €400 million, plus royalties on net sales.
Promising Pipeline Candidates
CIL001, introduced by Cilcare in 2020, is a novel treatment candidate with auditory nerve protection properties. In non-clinical trials, it has demonstrated the ability to improve the amplitude of the first wave of auditory brainstem response (ABR) and promote the reconnection of cochlear synapses that connect inner ear sensory cells to the auditory nerve, thereby potentially improving hearing function.
Preparatory activities are currently underway to collect auditory data in patients with type 2 diabetes or mild cognitive impairment. Phase 2a studies are planned for fiscal year 2025 to evaluate the safety and efficacy of CIL001 in patients with type 2 diabetes who have cochlear synaptopathy.
Meanwhile, preclinical studies for CIL003 are ongoing. Shionogi will decide whether to exercise its option rights based on the results of these studies.
The Growing Challenge of Hearing Loss
The significance of this partnership is underscored by the growing prevalence of hearing loss globally. The condition often develops gradually, making it difficult for patients to recognize symptoms early, which contributes to low diagnosis rates. Beyond communication difficulties, hearing loss can lead to social isolation, reduced productivity, and increased healthcare costs.
The World Health Organization and other health authorities have increasingly recognized hearing loss as a major public health concern requiring more effective interventions. Current management options are largely limited to hearing aids and cochlear implants, with no approved pharmacological treatments that address the underlying causes of most forms of hearing loss.
Through this collaboration, Shionogi and Cilcare aim to develop treatments that could potentially address this significant gap in care, potentially improving outcomes for millions of people worldwide affected by hearing impairment.
