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Boehringer Ingelheim and Sosei Heptares join forces to develop schizophrenia treatments

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Boehringer Ingelheim and Sosei Heptares have entered a global collaboration and exclusive option-to-license agreement.

At the center is a joint mission to develop and commercialize Sosei Heptares’ portfolio of first-in-class GPR52 agonists, a novel G protein-coupled receptor (GPCR) target, with the intent to improve patient outcomes by simultaneously addressing positive, negative, and cognitive symptoms of schizophrenia.

Schizophrenia is a serious condition that affects about 1 in 100 people worldwide. It is characterized by three clusters of symptoms: ‘positive’ symptoms, such as psychosis, delusions and hallucinations, ‘negative’ symptoms, such as social withdrawal and apathy, and cognitive symptoms, such as attention, planning and memory deficits.

The impact of these symptoms on people’s ability to cope with normal day-to-day life is significant and the related burden on carers and society at large is substantial, especially since the age of onset of the disease is typically in the 20’s. While ‘positive’ symptoms can be stabilized with antipsychotics, some of which can have side effects, there are currently no approved medicines for ‘negative’ or cognitive symptoms.

The development of a new schizophrenia treatment targeting GPR52 has the potential to address all three aspects of schizophrenia providing a novel precision treatment. This is based on the location of the receptor in the two areas of the brain that drive the positive (the striatum) and the negative and cognitive symptoms (the prefrontal cortex). The GPR52 agonism calms the striatum while boosting frontal cortical function, which achieves further precision in treatment.

“We’re very excited to enter this partnership with Sosei Heptares with this novel approach, which aims to address a huge unmet need of those living with schizophrenia. This partnership is highly complementary to our other development programs aiming to bring a new precision medicine approach to the treatment of mental health disorders with therapies, which we hope will transform the lives of those living with schizophrenia,” said Hugh Marston, Global Head CNS Discovery Research at Boehringer Ingelheim.

Matt Barnes, President of Heptares Therapeutics and Head of UK R&D at Sosei Heptares, said: “This collaboration highlights the significant potential GPR52 has shown in preclinical research as a novel, first in class target for the treatment of schizophrenia and related neurological disorders. We’re delighted to partner with Boehringer Ingelheim and leverage its leading expertise in neurological disease research and innovation. Together, we will focus on accelerating the development of this highly innovative program which is currently in a Phase 1 clinical research study, towards patients in need.”

Sosei Heptares will receive an upfront payment of €25 million from Boehringer Ingelheim upon signing, and is eligible for an option exercise payment of €60 million and further development, regulatory and commercialization milestone payments totaling up to €670 million plus customary tiered royalties for a clinical stage asset on future Boehringer Ingelheim product sales.

Under the terms of the agreement, Boehringer Ingelheim has the exclusive option to license Sosei Heptares’ portfolio of GPR52 agonists following the completion of Sosei Heptares’ ongoing Phase 1 and subsequent Phase 1b trial and further Phase 2 enabling activities with HTL0048149, a first-in-class GPR52 agonist. Sosei Heptares will retain control and act as sponsor of these trials until option exercise, estimated in 2025. The licensed portfolio will include HTL0048149 as well as multiple differentiated back-up compounds designed by Sosei Heptares using its StaR® technology and structure-based drug design (SBDD) platform.

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