Sosei Heptares has dosed the first subject in a Phase I clinical trial of HTL0048149 (HTL’149) to treat schizophrenia and related neurological diseases.
The two-part, single-ascending and multiple-ascending dose, placebo-controlled, double-blind, randomised study is designed to evaluate the pharmacodynamics, pharmacokinetics, and safety of the first-in-class GPR52 agonist HTL’149 in healthy volunteers.
To be carried out in the UK, the study intends to enrol subjects aged 18-55 years.
The company plans to read out initial data from the trial in 12-18 months.
Sosei subsidiary Heptares Therapeutics president and UK research and development head Matt Barnes said: “It is the culmination of a rigorous internal programme that began with the selection of GPR52 as the right target to address the significant unmet needs of schizophrenia patients and the subsequent design of a novel and potentially first-in-class agonist molecule with the right therapeutic profile.
“Progression of HTL’149 from discovery into clinical trials is a great example of the power of our StaR/SBDD platform to generate high-quality candidates utilising the combined expertise of our platform, discovery and translational medicine teams.”
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A once-daily, orally available small-molecule drug, HTL’149 addresses positive symptoms associated with schizophrenia including hallucinations, delusions, and psychosis.
It will also treat cognitive impairment such as executive function, working memory, and attention along with negative symptoms such as social withdrawal.
Last July, Sosei Group and Cancer Research UK signed a clinical trial and licence agreement (CTLA) to advance the former’s selective EP4 antagonist HTL0039732 into trials.
As part of the CTLA, the Centre for Drug Development of Cancer Research UK sponsored, designed and executed a first-in-human Phase I/IIa study of the cancer immunotherapy candidate while Sosei handled CTA-enabling activities.
Sosei is also engaged in developing various therapeutics to treat gastroenterology, inflammatory, and immunology diseases, along with neurological disorders.