OSAKA & MONTPELLIER – Shionogi & Co., Ltd. and Cilcare have announced an exclusive option agreement to advance the development of innovative treatments for hearing loss. This collaboration grants Shionogi the rights to develop, manufacture, and commercialize Cilcare’s drug candidates, CIL001 and CIL003, aimed at addressing the significant global health issue of hearing loss.
Under the terms of the agreement:
- Shionogi will receive an exclusive option to license global rights to CIL001 and/or CIL003.
- Cilcare will receive an upfront payment of €15 million.
- Cilcare is eligible to receive up to €400 million in milestone payments upon successful development and commercialization of the drug candidates.
- Shionogi will decide whether to exercise the option right based on the results of the Phase 2a studies of CIL001 and preclinical study data of CIL003, both to be conducted by Cilcare.
If the development and commercialization of both compounds proceed successfully, total payments, including milestones and royalties, could reach approximately €400 million. The agreement allows Shionogi to acquire exclusive global licenses for CIL001 and/or CIL003, with the decision to exercise this option based on Phase 2a study results for CIL001 and preclinical data for CIL003, both conducted by Cilcare.
Drug Candidates to Treat Hearing Loss
CIL001 is a novel drug candidate with protective effects on auditory nerves, particularly aimed at treating cochlear synaptopathy—a condition affecting cochlear synapses in the inner ear and linked to increased dementia risk in the elderly and complications in diabetes. Phase 2a studies for CIL001 are set to begin in 2025, focusing on patients with type 2 diabetes who have cochlear synaptopathy. Concurrently, preclinical studies for CIL003 are underway.
Hearing loss impacts approximately 1.5 billion people globally, with projections indicating that by 2050, a quarter of the world’s population may experience some degree of hearing deficiency. Cochlear synaptopathy, a form of hidden hearing loss, affects about 15% of the population despite normal hearing test results. This condition, leading to speech comprehension difficulties and other symptoms, underscores the urgent need for effective therapies.
Celia Belline, CEO of Cilcare, expressed her pride in partnering with Shionogi, highlighting the potential to expand their pipeline and drive innovation in hearing therapeutics. Isao Teshirogi, CEO of Shionogi, emphasized the alignment with their strategic focus on improving global health and well-being, aiming to deliver treatments for diseases with high unmet medical needs, including hearing loss.
The collaboration between Cilcare and Shionogi marks a pivotal step in addressing the global hearing loss crisis, offering hope for millions of individuals. For this agreement, Cilcare was advised by Agile Capital Markets and McDermott Will & Emery.
About Cilcare Development
Founded in 2014, Cilcare is a biotech company dedicated to advancing auditory sciences through early diagnosis and targeted treatment of hearing impairments, often associated with chronic diseases. Cilcare is pioneering in developing pharmaceuticals, medical devices, gene therapies, and cell therapies for hearing loss and tinnitus.
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a global research-driven pharmaceutical company focused on providing the best possible medicine to protect patient health and well-being. Shionogi has developed novel antibiotics, HIV, and influenza treatments, and currently markets medicines for infectious diseases and central nervous system disorders. Their global pipeline includes research in infectious diseases, pain/CNS, metabolic disorders, rare diseases, oncology, and stroke.
About CIL001
CIL001 is a novel candidate drug for hearing loss treatment with auditory nerve protective effect. In preclinical studies to date, CIL001 has been confirmed to have an organic effect that repairs inner ear cochlear synapses, and a functional effect that improves the first wave of the auditory brainstem response (ABR).
