Swiss company Synendos therapeutics has been given the go-ahead from the European Medicines Agency (EMA) to advance its lead candidate, SYT-510, into a Phase I clinical trial to treat neuropsychiatric disorders.

The first-in-class inhibitor targets endocannabinoids—naturally occurring, lipid-based neurotransmitters that help to maintain homeostasis. SYT-510 is said to inhibit endocannabinoid reuptake, which raises the amount of those neurotransmitters available in the synaptic cleft and increases neurotransmission.

In the upcoming planned Phase I first-in-human trial, the focus will be on assessing the safety, tolerability and pharmacokinetics in healthy patients receiving increasing single doses of SYT-510.

Basel headquartered-Synendos was spun out of the University of Bern in 2019, raising $27.8m in two Series A funding rounds in 2020 and 2021, co-led by Kurma Partners, Sunstone Life Science Ventures, and Ysios Capital.

The company secured a two-year Eurostars grant in 2021, a European Union (EU) funding scheme, named the EndoCARE programme, to propel preclinical studies for post-traumatic stress disorder (PTSD) by restoring endocannabinoid balance and exploring early clinical biomarkers.

A GlobalData analyst highlighted that cannabinoid receptors are the most popular target in preclinical development, however using these candidates are controversial as cannabinoid-based drugs are derived from compounds found in the cannabis plant.

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While cannabinoid receptors increase in popularity, navigating the regulatory environment is challenging. At the national level in the US, the largest pharmaceutical market globally, cannabinoids remain illegal under the Controlled Substances Act, despite legalisation allowing medical use in many states.

Medical use of cannabinoids is permitted in many EU nations, but accessibility is restricted with a special permit granted in specific cases.

In 2018, the US Food and Drug Administration (FDA) approved the first anti-epileptic medical marijuana therapy, marketed by GW Pharma which is now part of Jazz Therapeutics, Epidiolex (cannabidiol). Epidiolex generated $736.4m in 2022, according to Jazz Therapeutics’ 2022 annual report. According to GlobalData’s Pharma Intelligence Center, Epidiolex is forecast to generate $1.46bn in 2029.

In the announcement accompanying the approval, chief executive officer of Synendos Andrea Chicca said: “The transition to a clinical stage company marks a significant milestone and step forward for Synendos and for SYT-510, the first candidate in our new class of SERI molecules.

More than a decade of research resulted in our identification of a completely new mechanism for treating complex neuropsychiatric conditions, and this has already demonstrated very promising pre-clinical results.”