A Phase 1b, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate Safety, Tolerability and Pharmacokinetics of a Two-Week Oral Treatment With STP1 in a Subgroup of Patients With Autism Spectrum Disorder

The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD). In addition, Pharmacokinetics and Pharmacodynamics, as well as efficacy of STP1 are being explored.

开始日期2020-12-07

申办/合作机构

Stalicla SA初创企业

100 项与异丁司特/布美他尼相关的临床结果

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100 项与异丁司特/布美他尼相关的转化医学

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100 项与异丁司特/布美他尼相关的专利（医药）

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项与异丁司特/布美他尼相关的文献（医药）

2022-01-01·Chemosphere2区 · 环境科学与生态学

The occurrence of non-steroidal anti-inflammatory drugs (NSAIDs) in Malaysian urban domestic wastewater

2区 · 环境科学与生态学

Article

作者: Abd Manan, Teh Sabariah Binti ; Bachi', Nur Aina ; Abdullah, Nor Azura ; Ahmad, Amirrudin ; Wan Rasdi, Nadiah ; Mohd Hanafiah, Zarimah ; Mohd Kamal, Nur Liyana ; Beddu, Salmia ; Abd Hamid, Haris Hafizal ; Wan Mohtar, Wan Hanna Melini

The water stream has been reported to contain non-steroidal anti-inflammatory drugs (NSAIDs), released from households and premises through discharge from Sewage Treatment Plant (STP). This research identifies commonly consumed NSAIDs namely ibuprofen (IBU), diclofenac (DIC), ketoprofen (KET) and naproxen (NAP) in the influent wastewater from two urban catchments (i.e. 2 STPs). We expand our focus to assess the efficiency of monomer (C18) and dimer (HLB) types of sorbents in the solid phase extraction method followed by gas chromatography mass spectrometry (GCMS) analysis and optimize model prediction of NSAIDs in the influent wastewater using I-Optimal design. The ecological risk assessment of the NSAIDs was evaluated. The HLB produced reliable analysis for all NSAIDs under study (STP1: 6.7 × 10^-3 mg L^-1 to 2.21 × 10^-1 mg L^-1, STP2: 1.40 × 10^-4 mg L^-1 to 9.72 × 10^-2 mg L^-1). The C18 however, selective to NAP. Based on the Pearson proximity matrices, the DIC_HLB can be a good indicator for IBU_HLB (0.565), NAP_C18 (0.721), NAP_HLB (0.566), and KET_HLB (0.747). The optimized model prediction for KET and NAP based on DIC are successfully validated. The risk quotients (RQ) values of NSAIDs were classified as high (RQ > 1), medium (RQ, 0.1-1) and low (RQ, 0.01-0.1) risks. The optimized models are beneficial for major NSAIDs (KET and NAP) monitoring in the influent wastewater of urban domestic area. An upgrade on the existing wastewater treatment infrastructure is recommended to counteract current water security situation.

2021-01-01·Journal of Advanced Veterinary and Animal Research

Clinical pharmacology of tramadol and tapentadol, and their therapeutic efficacy in different models of acute and chronic pain in dogs and cats

Review

作者: Won, Yong-Kwan ; Kim, Sung-Jae ; Han, Jeong-Hee

OBJECTIVEThe efficacy of Salmonella typhimurium-specific bacteriophage STP-1 on S. typhimurium infection in weaning piglets was evaluated in this study.MATERIAL AND METHODSTwenty-eight weaning piglets were randomly allocated to four groups (Group A: non-challenged/basal; Group B: non-challenged/+phage; Group C: challenged/basal; Group D: challenged/+phage) according to S. typhimurium infection or bacteriophage administration. The total experimental period (14 days) was subdivided in to non-challenged periods (phase I; day 1-7) and challenged periods (phase II; day 7-14) based on the challenging date (day 7). Each group was fed with basal feed or feed supplemented with bacteriophage STP-1 [1.0 × 10⁹ plaque-forming unit (PFU)/kg] during the whole period (day 1-14). Body weights (BW) were measured to evaluate growth performance. Clinical symptoms (rectal temperatures and fecal consistency) induced by S. typhimurium were regularly checked. Bacteria colonization levels in feces and intestinal tissue samples were measured using real-time polymerase chain reaction (PCR). After necropsy, small intestine samples (jejunum) were collected. Villus height and crypt depth (CD) were measured through histological examination with H&E staining.RESULTSThe supplementation of bacteriophage significantly reduced bacterial colonization and intestine damage in the piglets infected with S. typhimurium. In the antigen concentrations of the feces and jejunum, Group C showed 5.8 ± 0.6, 5.7 ± 0.6, and 1.2 ± 2.0 log colony-forming unit (CFU)/ml on 1, 3, and 7 days post-inoculation (DPI) and 2.8 ± 1.3 log CFU/ml, whereas Group D showed 3.5 ± 1.7, 2.2 ± 2.1, and 0.3 ± 0.9 log CFU/ml on 1, 3, and 7 DPI and 5.1 ± 0.9 log CFU/ml. In the villous height, Groups C and D showed 266.3 ± 24.1 and 324.6 ± 18.0 μm, respectively. In the goblet cell density of villi and crypts, Group C showed 10.0 ± 1.8 and 16.0 ± 3.7, while Group D showed 15.0 ± 4.8 and 21.1 ± 5.4. Also, the supplementation of bacteriophage significantly improved the growth performance in the infected piglets. The average daily gains of Groups C and D were 91 ± 24 and 143 ± 23, respectively, during the period after inoculation with S. typhimurium.CONCLUSIONThe dietary supplementation of the phage was effective for alleviating S. typhimurium infection in post-weaning piglets.

2017-10-01·Carbohydrate Polymers1区 · 化学

Optimization of microwave-assisted extraction of Sargassum thunbergii polysaccharides and its antioxidant and hypoglycemic activities

1区 · 化学

Article

作者: Chen, Chun ; Fu, Xiong ; Liu, Rui Hai ; Ren, Beibei ; Li, Chao ; You, Lijun

In the present work, optimization of microwave-assisted extraction of polysaccharides from Sargassum thunbergii was investigated. The physicochemical properties, structural characteristics, and in vitro antioxidant and hypoglycemic activities were determined. The optimal extraction conditions with a yield of 2.84±0.09% for extraction of polysaccharides (STP-1) were extraction time 23min, microwave power 547W, extraction temperature 80°C, and the ratio of raw material to water 1:27g/mL. STP-1 contained 32.7% of total carbohydrate, 1.86% of protein, and 15.2% of sulfates. STP-1 had a major molecular weight of 190.4kDa, and comprised of arabinose, galactose, glucose, xylose, mannose, galacturonic acid, and glucuronic acid with molar percentages of 1.94, 30.7, 4.54, 23.2, 17.6, 8.11, and 13.9%, respectively. In addition, STP-1 showed strong antioxidant and α-glucosidase inhibitory activities, and could improve the glucose uptake in insulin-resistant HepG2 cells, suggesting that STP-1 can be exploited as a promising natural antioxidant and hypoglycemic agent.

项与异丁司特/布美他尼相关的新闻（医药）

2024-09-19

·GlobeNewswire-Health Care

Dr. Paulo Fontoura, MD, PhD, joins STALICLA as Chief Scientific and Clinical Development Advisor

Press Release Dr. Paulo Fontoura, MD, PhD, joins STALICLA as Chief Scientific and Clinical Development Advisor Geneva, Switzerland – September 19, 2024 – STALICLA SA, a Swiss neuro precision biotech company dedicated to developing precision medicine-based treatments for neurodevelopmental disorders, announced today that Dr. Paulo Fontoura will be joining their drug development team as Chief Scientific and Clinical Development Advisor. Dr. Fontoura will work to support STALICLA’s mission to transform the treatment landscape for neurodevelopmental disorders. Lynn Durham, CEO of STALICLA, said: “We are delighted and humbled to welcome Paulo to the STALICLA team. With his unparalleled insight and unique understanding of CNS drug development and neurodevelopmental disorders, he is strengthening STALICLA’s position as a pioneer in precision neuropsychiatry. Paulo’s expertise will be instrumental in helping us achieve our next milestones, notably our entry into two Phase 2 clinical trials in subgroups of patients with autism spectrum disorder (ASD), each with expected readouts in the coming 24 months.” Dr. Paulo Fontoura is a pioneer in innovative clinical development strategies. During his 16-year tenure at Roche, he served as the Global Head of Neuroscience Clinical Development; he was instrumental in the launch of several groundbreaking medications targeting neurological conditions, including Multiple Sclerosis (MS), Spinal Muscular Atrophy (SMA), and Neuromyelitis Optica Spectrum Disorder (NMOSD), as well as pioneering work on Alzheimer's, Parkinson's, Huntington's disease, and several psychiatric and neurodevelopmental disorders. Specifically, he and his team spearheaded the clinical development of new therapies for Fragile X, Down's and Angelman's syndromes, and the first pharmacological treatment for core symptoms of ASD which reached Phase 3 clinical trials in both adults and children. Additionally, his team co-led the Autism Innovative Medicine Studies (AIMS) including EU-AIMS and AIMS-2-TRIALS public private partnership. Dr. Fontoura has also had an illustrious academic career. He held multiple faculty positions at the New University of Lisbon and Stanford University, where he earned his MD and a PhD in Neuroimmunology and trained as a clinical neurologist. In recognition of his exceptional achievements in the field of neuroscience, he was elected as a Fellow of the American Academy of Neurology in 2022. He currently serves as a visiting professor at the New University of Lisbon and lectures at the European Center of Pharmaceutical Medicine in Basel. Paulo Fontoura MD, PhD, Chief Scientific and Clinical Development Advisor, said: “I am thrilled to join the STALICLA team and help them develop therapies for people with neurodevelopmental disorders. Their approach promises to bring real breakthroughs in this area of great medical need.” About STALICLA: STALICLA SA is a Swiss clinical-stage biopharmaceutical company, revolutionizing the treatment of neurodevelopmental disorders. The company has developed a clinically validated neuro precision development platform, successfully delivering stratified patient subgroups and advancing tailored treatment options. Its lead NDD asset, STP1, and a second NDD asset are set to enter Phase 2 trials with expected readouts within 24 months. STP7 (Mavoglurant), is also being advanced for Phase 3 trials, fully funded by the US government. For more information, please visit: www.stalicla.com. Contacts: STALICLA SALynn Durham Founder & Chief Executive Officerlynn.durham@stalicla.com Media & InvestorsChris MaggosCohesion Bureauchris.maggos@cohesionbureau.com+41 79 367 6254 Attachment 20240918 Paulo Fontoura PR_final

临床2期临床3期高管变更

2024-06-28

·GlobeNewswire-Health Care

STALICLA publishes pioneering phase 1b data on precision treatment for autism spectrum disorder in Biomedicines

STALICLA’s precision psychiatry study highlights strong EEG-based target engagement of STP1 treatment in defined subgroup of patients with autism and numerical improvement in core symptoms June 27, 2024 – STALICLA SA, a Swiss neuro precision biotech company dedicated to developing precision medicine-based treatments for neuropsychiatric and neurodevelopmental disorders, today announced the publication of a landmark phase 1b study with STP1, a novel combination therapy tailored for the treatment of a clinically and biologically defined subgroup of patients with autism spectrum disorder (ASD), named ASD Phenotype 1 (ASD-Phen1). The results of the study were published in the peer-reviewed journal Biomedicines, in an article titled “Safety, Tolerability, and EEG-Based Target Engagement of STP1 (PDE3,4 Inhibitor and NKCC1 Antagonist) in a Randomized Clinical Trial in a Subgroup of Patients with ASD”. Lynn Durham, CEO of STALICLA, highlighted: “This study marks a significant milestone in the advancement of precision medicine for ASD. It is a first-of-its-kind stratification-based approach for clinical development in neurodevelopmental disorders, demonstrating the potential of precision medicine in ASD.” The randomized, double-blind, placebo-controlled phase 1b clinical trial evaluated the safety and tolerability of STP1, a combination of ibudilast and bumetanide, in ASD-Phen1 patients. The clinical trial (registered at clinicaltrials.gov NCT04644003), involved two 14-day treatment phases of ASD-Phen1 patients receiving STP1 or placebo. The results showed that STP1 was well-tolerated with no significant adverse effects reported. Significant and dose-related reductions in gamma power were observed in the whole brains of patients taking STP1, particularly in regions associated with executive function and memory. Additionally, STP1 increased alpha 2 power in frontal and occipital regions, while improving habituation and neural synchronization to auditory chirps. Dr. Craig A. Erickson, Associate Professor, UC Department of Psychiatry and Behavioral Neuroscience, Cincinnati Children’s Hospital Medical Center, and the principal investigator of the study, remarked: “The electrophysiological signals from this study are remarkable and represent the strongest early trial target engagement signals our lab has seen in the autism field.” Dr. Laura Pérez-Cano, Head of Discovery at STALICLA and co-author of the study, added: “These findings not only highlight the potential of STP1 as a therapeutic option for ASD-Phen1 patients but also underscore the importance of combining biologically-based patient stratification with quantifiable outcome measures such as EEG that can then be correlated with behavioral measures.” By focusing on a biologically defined subgroup of ASD patients, STALICLA is moving closer to making personalized treatment options a reality for patients with ASD. This approach has the potential to revolutionize the treatment of ASD and other neuropsychiatric conditions. STALICLA is a global, clinical-stage biotechnology company focused on advancing precision medicine for brain disorders. The company has developed a unique neuro precision development platform, DEPI, supported by clinical validation in a first indication: Autism Spectrum Disorder. Its lead neurodevelopmental disorder asset, STP1, is entering Phase 2 trials. Its lead neuropsychiatry asset, STP7 (Mavoglurant), fully funded by the US government, will soon be Phase 3 ready for Cocaine Use Disorder. ‎ The content above comes from the network. if any infringement, please contact us to modify.

临床结果

2024-01-17

·Pharmaceutical Technology

Stalica raises $17.5m to advance neurology programmes

The ASD pipeline consists of 127 drugs spanning all stages of development, with only 7% of drugs present in Phase III and 11.8% in Phase II clinical development. Image Credit: Alex and Maria photo / Shutterstock. Switzerland-based Stalica has raised $17.5m in Series B financing to fund clinical trials for its neuropsychiatric and neurological disorders pipeline. The clinical programmes that the company plans to use the Series B proceeds include the fixed-dose combination drug STP1 and mavoglurant (STP7). Furthermore, the company will also strengthen the data package for STP2. Stalica’s clinical pipeline STP1 is a fixed dose combination of ibudilast, a phosphodiesterase (PDE) 4/3 inhibitor, and bumetanide, a sodium (Na)- potassium (K)- chloride (Cl) cotransporter (NKCC) 1 agonist. Stalica is developing the precision therapy as a treatment for autism spectrum disorder (ASD) in a specific sub-group of patients, phenotype 1 (Phen1). Phen1 patients have been identified by Stalica and validated using two independent clinical observational/bio-sampling studies (NCT05590715 and NCT04644003). The company is planning a Phase II trial for STP1 in patients with ASD, the preparation of which will be funded by the proceeds from the current financing round. Mavoglurant is a negative allosteric modulator of the glutamate receptor 5 (mGluR5). Stalica signed an in-licencing agreement with Novartis to develop the drug as a treatment for substance-use disorders and neurodevelopmental disorders (NDDs) in January 2023. As per the agreement, the company is entitled to receive up to $270m in upfront and milestone-based payments along with royalties on net sales. The company is planning a Phase III trial for mavoglurant in patients with cocaine use disorder in 2025. The trial will be funded by the US National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH). It is expected to enrol up to 330 patients. STP2 is a stabilised synthetic form of sulforaphane. Stalica acquired the rights to the therapy from the UK-based Evgen Pharma in October 2022. Stalica is developing STP2 as a treatment for ASD in Phen2 sub-population. The company plans to start Phase II trial for the therapy in 2023. ASD landscape The total diagnosed prevalence of ASD was more than 9.81 million in 2023 and is expected to be approximately 9.65 million diagnosed prevalent cases of ASD in 2028, as per a 2023 Globaldata report . The ASD pipeline consists of 127 drugs spanning all stages of development, with only 7% of drugs present in Phase III and 11.8% in Phase II clinical development. GlobalData is the parent company of Pharmaceutical Technology . In November 2023, SciSparc started a clinical trial for SCI-210 to treat ASD symptoms in children. SCI-210 is a combination of cannabidiol (CBD) and palmitoylethanolamide. The trial is expected to enrol 60 patients aged five and 18 years. Apart from ASD treatment, strides have been made in developing diagnostics for the disorder. In September 2023, EarliTech positive data from two studies showing the efficacy and accuracy of its EarliPoint Evaluation device in diagnosing and assessing autism in children aged 30 months and older.

临床2期临床3期

100 项与异丁司特/布美他尼相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
自闭症谱系障碍	临床1期	美国	Stalicla SA初创企业	2020-12-07

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04644003 (CTgov)	临床1期	自闭症谱系障碍	12	STP1 (STP1 Low Dose)	(積網積蓋淵夢淵簾顧齋) = 顧範膚蓋顧窪簾餘夢鏇鹽餘選築壓鏇網夢糧網 (壓簾淵範膚艱鏇願顧簾, 衊鬱選鹽餘醖積蓋鑰築 ~ 積網憲廠膚鹹選選遞鑰) 更多	-	2024-11-08
				STP1 (STP1 High Dose)	(積網積蓋淵夢淵簾顧齋) = 鬱襯窪夢繭膚鬱蓋鹽築鹽餘選築壓鏇網夢糧網 (壓簾淵範膚艱鏇願顧簾, 餘壓齋壓觸獵觸憲憲鏇 ~ 獵構繭獵網衊鑰積鹹壓) 更多