Sosei to Advance Clinical Development in Japan of HTL0018318 in Patients with Dementia with Lewy Bodies (DLB)
Amendment of global R&D and commercialisation partnership between Heptares and Allergan designed to expand clinical development of HTL0018318 in major dementia indication
HTL0018318 is a novel muscarinic M1 receptor agonist in clinical development as a potential treatment for cognitive impairment in Alzheimer’s disease
Tokyo, Japan and London, UK – 9 November 2017: Sosei Group Corporation (“Sosei”); TSE Mothers Index:4565) announces that it has agreed with Allergan to an amendment to the 2016 global R&D and commercialisation partnership between Allergan and Sosei’s subsidiary Heptares Therapeutics, in which Allergan gained exclusive rights to Heptares’ broad portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer’s disease (AD).
The amendment sees Sosei gain a licence to develop and commercialise HTL0018318, a novel muscarinic M1 receptor agonist, in Japan as a potential new treatment for patients with dementia with Lewy bodies (DLB). Initially, Sosei will undertake a Phase 2 proof-of-concept monotherapy study, expected to begin in Japan in 2018. Allergan has retained the right to develop HTL0018318 in DLB globally.
DLB is the second most common form of degenerative dementia after AD and relates to dementia associated with the presence of Lewy bodies (abnormal deposits of a protein called alpha-synuclein) in the brain that affect behaviour, cognition and movement. In DLB, loss of presynaptic cholinergic (acetylcholine-producing) neurons is thought to be a key driver of disease symptoms. As in AD, postsynaptic neurons and muscarinic receptors in DLB are preserved, which presents an important opportunity for a selective M1 agonist based approach.
DLB affects up to an estimated 20-30% of all dementia patients. In Japan, this represents approximately 920,000 individuals, and in the US approximately 1.4 million individuals. There are no approved therapies for DLB in the US or Europe, while branded donepezil (Aricept®, Eisai) is conditionally approved in Japan.
Commenting on the announcement, Peter Bains, CEO at Sosei, said: “This is a very exciting development in our partnership with Allergan. It provides Sosei with a major go-to-market opportunity for our lead program, which is consistent with our growth strategy. Sosei has developed an extensive understanding of the DLB opportunity in Japan, and alongside our clinical development capabilities and track record of successful product development in Japan we believe we can add significant value to the M1 agonist program overall through this activity.”