Sosei Heptares Administers First Dose in Phase I Trial Evaluating HTL0048149, a Novel GPR52 Agonist for Schizophrenia
Monday, July 03, 2023
Sosei Group Corporation (TSE: 4565) has commenced a Phase I clinical trial for HTL0048149 (HTL'149), an innovative GPR52 agonist. The drug is being developed for the treatment of schizophrenia and related neurological diseases.
HTL'149, created using Sosei Heptares' StaR® technology and SBDD platform, is a small molecule drug that can be taken orally once a day. It offers antipsychotic and pro-cognitive effects while minimizing the adverse effects typically associated with existing antipsychotic drugs. By selectively targeting the orphan GPR52 receptor in the brain, HTL'149 aims to address the positive symptoms (e.g., psychosis, delusions, hallucinations), negative symptoms (e.g., social withdrawal), and cognitive impairment (e.g., attention, working memory, executive function) associated with schizophrenia.
The unique mechanism of action of HTL'149 aims to benefit schizophrenia patients who do not respond to or experience side effects from current antipsychotics. It also seeks to address the limitations of existing antipsychotic drugs in treating the negative and cognitive symptoms of the disease.
The Phase I trial is a two-part study involving healthy volunteers aged 18-55 years. It is a randomized, double-blind, placebo-controlled trial that will evaluate the safety, pharmacokinetics, and pharmacodynamics of oral HTL'149. The trial will be conducted in the UK, with initial data expected to be available within 12-18 months.
Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, emphasized the importance of this milestone for Sosei Heptares. He highlighted the rigorous internal program that led to the selection of GPR52 as the target and the subsequent development of HTL'149, which has the potential to be a first-in-class agonist with the desired therapeutic profile. Barnes also acknowledged the power of Sosei Heptares' StaR/SBDD platform and the collaborative efforts of their platform, discovery, and translational medicine teams in bringing HTL'149 from discovery to clinical trials.
