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Roche signs autism spectrum drug development partnership

Deal with Seaside Therapeutics will also see the firms research treatments for fragile X syndrome

Roche has signed a new drug development collaboration that will see it search for new treatments for autism spectrum disorders (ASD) and fragile X syndrome (FXS).

The Swiss pharma company will partner with Seaside Therapeutics, licensing patents from the Cambridge, US-based firm for the use of treatments that target the brain's mGluR5 receptor, which is being investigated for its role in the onset of neurodevelopmental disorders, such as ASD and FXS.

Roche will then lead the development and commercialisation of these compounds, which include the drug candidate RG7090. This is in phase II clinical trials assessing its use in FXS, a genetic condition that involves a faulty gene in a person's X chromosome and is the most common known cause of inherited learning disabilities.

The drug's target, the mGluR5 receptor, is involved in both learning and memory, and balances out the gene encoding fragile X mental retardation protein (FMRP), according to Roche.

However, when FMRP function is lost, as is the case in FXS, the mGluR5 receptor functions unopposed, leading to neurodevelopmental problems.

It is hoped this can be countered by also inhibiting the function of mGluR5, with Roche claiming that early trial results suggest children with FXS can be helped by drugs that restrain mGluR5 activity.

“Roche is committed to finding new treatments in areas of high unmet medical need such as autism spectrum disorders,” said Luca Santarelli, global head of Roche Neuroscience. “Recent discoveries in genetics have shed light on the biological underpinnings of these conditions thus providing a basis for mechanistic drug discovery.

The pharma company will also have an option to commercialise separate drug candidate and GABA-B agonist, STX209, which Seaside is also developing for use in FXS and ASD – a group of cognitive disorders that includes autism and Asperger's syndrome.

Roche's involvement is dependent on the completion of certain clinical development phases, however, and Seaside continues to retain exclusive rights to patents covering the use of the compound and will lead its clinical development programme. This also applies to all other GABA-B agonists it has in development.

These compounds aim to target GABA-B receptors, which play an important role in modulating the release of glutamate – an acid that has been linked to both ASD and FXS.

“This collaboration is a real win for patients and caregivers - aligning leading minds and organizations committed to rapidly advancing transformational drugs to treat autism and fragile X syndrome,” said Dr Randy Carpenter, Seaside's president and CEO.

“Importantly, this collaboration also provides Seaside with additional resources to complete late-stage clinical development of STX209, which we believe has the potential to change the treatment paradigm for fragile X and autism and thereby help patients and their families achieve an improved quality of life.”

20th June 2012


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