Japan-based Shionogi & Co. has entered into an option agreement with French firm Cilcare DEV SAS to acquire the exclusive license for the development, manufacturing, and commercialisation of CIL001 and/or CIL003, the hearing loss treatment drug candidates worldwide.

In conjunction with the signing of the agreement, Shionogi will make an upfront payment of Euros (€) 15 million to Cilcare. If Shionogi exercises its option for both compounds and development and commercialisation proceeds successfully, the total of the option payments and development, regulatory, and sales milestones may reach approximately Euros 400 million, plus royalties on net sales.

Cilcare has been developing CIL001, a novel candidate drug for hearing loss treatment with auditory nerve protective effects. Currently, preparatory activities are underway to collect auditory data in patients with type 2 diabetes or mild cognitive impairment.

From the fiscal year 2025, Phase 2a studies are planned to evaluate the safety and efficacy of CIL001 in patients with type 2 diabetes who have cochlear synaptopathy. Additionally, preclinical studies for CIL003 are currently underway. 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.

Hearing loss is a major global health issue affecting around 1.5 billion people worldwide. Its incidence is rapidly increasing, with predictions that, by 2050, a quarter of the global population will experience varying degrees of hearing deficiency. The economic loss due to unaddressed hearing loss is said to be around 1 trillion dollars annually, and there is a demand for new therapeutic drugs.