Boehringer Ingelheim and Sosei Group Corporation have recently announced a global collaboration and an exclusive option-to-license agreement. The primary goal of this partnership is to jointly develop and commercialize Sosei Heptares' innovative GPR52 agonists, targeting a novel G protein-coupled receptor (GPCR), with the objective of improving patient outcomes by addressing positive, negative, and cognitive symptoms associated with schizophrenia.

Schizophrenia, a severe mental disorder affecting about 1 in 100 individuals worldwide, is characterized by three main symptom clusters: positive symptoms like psychosis, delusions, and hallucinations; negative symptoms such as social withdrawal and apathy; and cognitive symptoms including attention, planning, and memory deficits. These symptoms significantly impact daily functioning, especially considering the disease typically begins in the 20s. While antipsychotics can manage positive symptoms, there are currently no approved medications for negative or cognitive symptoms.

The collaboration aims to develop a new treatment targeting GPR52, which shows promise in addressing all three symptom clusters of schizophrenia. GPR52 agonists act on specific brain regions—the striatum and the prefrontal cortex—alleviating positive symptoms while enhancing frontal cortical function to target negative and cognitive symptoms precisely.

Hugh Marston, Global Head CNS Discovery Research at Boehringer Ingelheim, expressed enthusiasm about the partnership, highlighting its potential to address the significant unmet needs of individuals with schizophrenia. Matt Barnes, President of Heptares Therapeutics and Head of UK R&D at Sosei Heptares, emphasized the substantial potential of GPR52 as a novel therapeutic target based on preclinical research.

As part of the agreement, Sosei Heptares will receive an upfront payment of EUR 25 million from Boehringer Ingelheim upon signing, with additional milestone payments totaling up to EUR 670 million, alongside customary royalties on future sales. Boehringer Ingelheim holds an exclusive option to license Sosei Heptares' portfolio of GPR52 agonists following the completion of ongoing clinical trials.

GPR52, highly expressed in the brain, offers a potential therapeutic avenue for various neurological and neuropsychiatric disorders. Sosei Heptares has developed selective GPR52 agonists and modulators, with HTL0048149 being the most advanced, currently undergoing Phase 1 clinical trials.

HTL0048149, designed for once-daily oral administration, aims to target GPR52 with an antipsychotic and pro-cognitive profile. It seeks to address the limitations of existing antipsychotic drugs by targeting all symptom clusters associated with schizophrenia while minimizing adverse effects.

The Phase 1a/b clinical trial of HTL0048149 is underway, with initial data expected in 2025, focusing on safety, pharmacokinetics, and pharmacodynamics in healthy volunteers aged 18-55 years.

In summary, the collaboration between Boehringer Ingelheim and Sosei Heptares aims to advance the development of innovative treatments for schizophrenia, potentially transforming the lives of affected individuals.

 

Source: globenewswire.com

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