Sosei Heptares announces first subject dosed in phase 1 trial for schizophrenia therapy

Betsy Goodfellow | July 3, 2023 | News story | Research and Development HTL'149, Neurology, Sosei Heptares, clinical trial, schizophrenia 

Sosei Heptares has announced that it has dosed its first patient in its phase 1 trial evaluating HTL0048149 (HTL’149), a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.

The drug was developed using Sosei Heptares’ StaR technology and SBDD platform, as a once-daily, orally available small molecule drug with an antipsychotic and pro-cognitive profile, aiming to avoid adverse effects typical of existing antipsychotic drugs. HTL’149 selectively targets the orphan GPR52 receptor in the brain meaning it can address positive symptoms (eg psychosis, delusions and hallucinations), negative symptoms (eg social withdrawal) and cognitive impairment (eg attention, working memory and executive function), all of which are associated with schizophrenia.

The phase 1 trial, that has just been initiated, is a two-part, randomised, double-blind, placebo-controlled, single- and multiple-ascending dose study intending to assess the safety, pharmacokinetics and pharmacodynamics of oral HTL’149 in healthy volunteers between the ages of 18 and 55. The trial is being conducted in the UK, with initial data expected in 12 to 18 months.

Matt Barnes, president of Heptares Therapeutics and head of UK R&D, commented: “The progression of this wholly owned, first-in-class asset into clinical trials is a very important milestone for Sosei Heptares. It is the culmination of a rigorous internal program 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.”

Betsy Goodfellow

Related Content

Nuvectis Pharma initiates phase 1a NXP900 clinical trial

Clinical stage biopharmaceutical company Nuvectis Pharma has announced the initiation of a phase 1a dose …


Neurocrine Biosciences begins phase 1 study assessing NBI-1117570 in healthy adults

Sosei Heptares has announced that its partner, Neurocrine Biosciences, has initiated its phase 1 first-in-human …

AstraZeneca and Daiichi Sankyo share positive results from DESTINY-Lung02 phase 2 trial

AstraZeneca and Daiichi Sankyo have announced results from the primary analysis of the DESTINY-Lung02 phase …

Latest content