Sosei (Japan) and Allergan (USA) have been forced to call a halt to testing of a drug for Alzheimer’s disease and other forms of dementia after cancer was seen in non-human primate studies.
The drug is one of the lead candidate from a $3.35 billion licensing deal Allergan agreed with Heptares Pharma, a Sosei subsidiary, two years ago, covering global rights to a portfolio of muscarinic agonists for the treatment of major neurological disorders, including Alzheimer’s disease.
The compound – called HTL0018318 – is in a phase 1 trial in the USA run by Allergan and a phase 2 trial in Japan run by Sosei, but recruitment will be suspended while the partners investigate the toxicity signal. It has already completed another phase 1 study and – according to the partners – has been well-tolerated with no evidence of cancer in around 310 patients treated to date.
The upshot however is that a broader phase 2 programme for the drug in Alzheimer’s and dementia with Lewy bodies (DLB) will be delayed by up to six months, setting back a development milestone payment from Allergan.
According to Sosei HTL0018318 acts as a selective M1 agonist that could provide another way of treating the symptoms of dementia by improving cholinergic neurotransmission, acting via a different mechanism to already-approved anticholinesterase drugs for Alzheimer’s like donepezil.
Established in 1990, Sosei Group Corporation is an international biopharmaceutical company originating from Japan that discovers and develops innovative biopharmaceuticals for the treatment of Alzheimer’s disease, schizophrenia, cancer, migraine, addiction, metabolic disease, and other indications. Sosei utilizes their platform technologies – GPCR structure-based drug design platform technology, peptide platform technologies and nanotechnology – to establish a product pipeline with first/best in class potential.