A Two-Part Study Investigating the Relative Bioavailability and the Potential Food Effect After a Single Oral Dose Administration of a New Formulation of SYT-510, and the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration of SYT-510 in Healthy Subjects

Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.

开始日期2024-10-30

申办/合作机构

Synendos Therapeutics AG初创企业

100 项与 SYT-510 相关的临床结果

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100 项与 SYT-510 相关的转化医学

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100 项与 SYT-510 相关的专利（医药）

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项与 SYT-510 相关的新闻（医药）

2024-01-18

·PRNewswire

Synendos Therapeutics AG Granted EMA Clinical Trial Authorisation for first-in-class Endocannabinoid System modulator, SYT-510

Synendos Therapeutics transitions to a clinical-stage biotech company developing innovative Endocannabinoid System (ECS) treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders Clinical Trial will investigate the safety, tolerability and pharmacokinetics of Synendos' first-in-class ECS modulator BASEL, Switzerland, Jan. 18, 2024 /PRNewswire/ -- Synendos Therapeutics AG (Synendos), a world leader in innovative Endocannabinoid System (ECS) treatments, today announces that it has received approval from the European Medicines Agency (EMA) to commence the Phase 1 'first-in-human' clinical trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the Endocannabinoid System to restore healthy brain physiology. The randomized, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetics of single-ascending doses of SYT-510 in healthy adult participants. Synendos is developing selective endocannabinoid reuptake inhibitors (SERIs) that influence the balance of the ECS in a novel mode of action. The ECS is a key neuromodulator system in the CNS which plays a significant role in how the body responds to stress. By rebalancing and restoring endogenous cannabinoid levels that are dysregulated in certain pathological conditions, this new mode of action has the potential to rebalance brain function in a holistic and pro-homeostatic way to treat neuropsychiatric disorders such as Post-Traumatic Stress Disorder (PTSD). Dr Andrea Chicca, Co-Founder and Chief Executive Officer of Synendos, commented: "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. With no new treatments available in this area for over 25 years, advances are desperately needed. By addressing this unmet need with our novel technology, we have the potential to offer those struggling with anxiety, mood and stress-related disorders a differentiated, safe and effective way to alleviate symptoms through the holistic rebalancing of brain physiology." Notes to Editors: About Synendos Therapeutics AG Synendos Therapeutics AG (Synendos) is a biopharmaceutical company developing first-in-class therapies to restore the healthy balance of brain physiology and meet the growing need for holistic and safe treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders. A world leader in innovative Endocannabinoid System (ECS) treatments, Synendos is developing a new class of small molecules – selective endocannabinoid reuptake inhibitors (SERIs) – aimed at restoring the natural functioning of the ECS in the brain with the potential for treating a wide range of CNS disorders. Spun out of the University of Bern and incorporated in April 2019, the Company's novel technology stems from more than 10 years of solid research on endocannabinoid biology and pharmacology carried out by co-founders, Professor Jürg Gertsch and Dr. Andrea Chicca. For more information, please visit . About SERIs Selective Endocannabinoid Reuptake Inhibitors (SERIs) are first-in-class endocannabinoid system modulators that mildly and selectively increase endogenous cannabinoids levels by inhibiting a newly identified drug target. SERIs act with a pro-homeostatic, self-limiting mechanism of action that enables a fine-tuned modulation of synaptic transmission in major neuronal circuits in the CNS. SERIs' new mode of action represents an innovative and potentially safer therapeutic approach to CNS disorders associated with anxiety, mood and stress-related conditions. SOURCE Synendos Therapeutics

临床1期

2024-01-18

·Pharmaceutical Technology

Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Endocanninaboids are naturally occurring endogenous ligands that target cannabinoid receptors. Credit: Summit Art Creations via Shutterstock. 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. GlobalData is the parent company of Pharmaceutical Technology. 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.”