A Phase III Long-Term Extension Trial with Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants with Major Depressive Disorder (EXTEND)

This is a long- term extension of the double-blind trial, APPROACH (CYB003-002). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

开始日期2025-02-23

申办/合作机构

Cybin IRL Ltd.

[+1]

NCT06564818 / Not yet recruiting临床3期

A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder

The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

开始日期2024-11-01

申办/合作机构

Cybin IRL Ltd.

[+1]

NCT06051721 / Recruiting临床2期

A Phase 2a, Randomized, Double-Blind, Active-Controlled Study to Assess the Preliminary Clinical Efficacy, Safety, Tolerability, and Pharmacokinetics, of CYB004 in Participants with Generalized Anxiety Disorder (GAD)

The purpose of this proof-of-concept trial is to examine the safety, tolerability, and pharmacokinetics (PK), and preliminary clinical efficacy of CYB004 participants with GAD.

开始日期2024-05-10

申办/合作机构

Cybin IRL Ltd.

[+1]

100 项与 Worldwide Clinical Trials LLC 相关的临床结果

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0 项与 Worldwide Clinical Trials LLC 相关的专利（医药）

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100

项与 Worldwide Clinical Trials LLC 相关的文献（医药）

2024-07-01·Spanish Journal of Psychiatry and Mental Health

Altered activation of the dorsal anterior cingulate cortex during oddball performance in individuals at risk for Alzheimer's disease

Article

作者: Guinea-Izquierdo, Andrés ; Menchón, José M ; Gascón-Bayarri, Jordi ; Urretavizcaya, Mikel ; Reñé-Ramírez, Ramón ; Soria, Virginia ; Ferrer, Isidre ; Del Río-Torné, Carla ; Chavarría-Elizondo, Pamela ; Martínez-Zalacaín, Ignacio ; Maturana-Quijada, Pablo ; Juaneda, Asier ; Del Cerro, Inés ; Soriano-Mas, Carles

INTRODUCTIONThe neural mechanisms underlying neurodegenerative disorders in the elderly remain elusive, despite extensive neuroimaging research in recent decades. Amnestic type mild cognitive impairment (aMCI) and late-life major depressive disorder (MDD) are two such conditions characterized by intersecting cognitive and affective symptomatology, and they are at a higher risk for Alzheimer's disease.MATERIALS AND METHODSThis study analyzed the neural underpinnings of cognitive and depressive symptoms in a cohort comprising 12 aMCI subjects, 24 late-life MDD patients, and 26 healthy controls (HCs). Participants underwent a detailed neuropsychological assessment and completed a visual attentional oddball task during functional magnetic resonance imaging (fMRI), with evaluations at baseline and at 2-year follow-up.RESULTSInitial findings showed that aMCI subjects had reduced dACC activation during oddball (target) stimulus detection, a pattern that persisted in longitudinal analyses and correlated with cognitive functioning measures. For HCs, subsequent dACC activation was linked to depression scores. Furthermore, in the affective-cognitive altered groups, later dACC activation correlated with oddball and memory performance.CONCLUSIONSThese findings enhance our comprehension of the neurobiological basis of cognitive and depressive disturbances in aging, indicating that dACC activation in response to a visual attentional oddball task could serve as a neural marker for assessing cognitive impairment and depression in conditions predisposing to Alzheimer's disease.

2024-05-01·Clinical and Translational Science

Re‐discover the value of protein binding assessments in hepatic and renal impairment studies and its contributions in drug labels and dose decisions

Review

作者: Courville, Jocelyn ; Roupe, Kathryn ; Arold, Gerhard

AbstractOne of the key pharmacokinetic properties of most small molecule drugs is their ability to bind to serum proteins. Unbound or free drug is responsible for pharmacological activity while the balance between free and bound drug can impact drug distribution, elimination, and other safety parameters. In the hepatic impairment (HI) and renal impairment (RI) clinical studies, unbound drug concentration is often assessed; however, the relevance and impact of the protein binding (PB) results is largely limited. We analyzed published clinical safety and pharmacokinetic studies in subjects with HI or RI with PB assessment up to October 2022 and summarized the contribution of PB results on their label dose recommendations. Among drugs with HI publication, 32% (17/53) associated product labels include PB results in HI section. Of these, the majority (9/17, 53%) recommend dose adjustments consistent with observed PB change. Among drugs with RI publication, 27% (12/44) of associated product labels include PB results in RI section with the majority (7/12, 58%) recommending no dose adjustment, consistent with the reported absence of PB change. PB results were found to be consistent with a tailored dose recommendation in 53% and 58% of the approved labels for HI and RI section, respectively. We further discussed the interpretation challenges of PB results, explored treatment decision factors including total drug concentration, exposure–response relationships, and safety considerations in these case examples. Collectively, comprehending the alterations in free drug levels in HI and RI informs treatment decision through a risk‐based approach.

2024-04-03·Antimicrobial Agents and Chemotherapy

Population pharmacokinetic rationale for intravenous contezolid acefosamil followed by oral contezolid dosage regimens

Article

作者: Bulitta, Jürgen B. ; Stryjewski, Martin E. ; Fang, Edward ; Atiee, George J. ; Stark, Jeffrey G. ; Hafkin, Barry ; Wang, Wen

ABSTRACTContezolid is a novel oxazolidinone antibiotic with a promising safety profile. Oral contezolid and its intravenous (IV) prodrug contezolid acefosamil (CZA) are in development for treatment of diabetic foot and acute bacterial skin and skin structure infections (ABSSSI). The prodrug CZA is converted to active contezolid via intermediate MRX-1352. This study aimed to provide the pharmacokinetic rationale for safe, effective, and flexible dosage regimens with initial IV CZA followed by oral contezolid. We simultaneously modeled plasma concentrations from 110 healthy volunteers and 74 phase 2 patients with ABSSSI via population pharmacokinetics (using the importance sampling estimation algorithm), and optimized dosage regimens by Monte Carlo simulations. This included data on MRX-1352, contezolid, and its metabolite MRX-1320 from 66 healthy volunteers receiving intravenous CZA (150–2400 mg) for up to 28 days, and 74 patients receiving oral contezolid [800 mg every 12 h (q12h)] for 10 days. The apparent total clearance for 800 mg oral contezolid with food was 16.0 L/h (23.4% coefficient of variation) in healthy volunteers and 17.7 L/h (53.8%) in patients. CZA was rapidly converted to MRX-1352, which subsequently transformed to contezolid. The proposed dosage regimen used an IV CZA 2000 mg loading dose with 1000 mg IV CZA q12h as maintenance dose(s), followed by 800 mg oral contezolid q12h (with food). During each 24-h period, Monte Carlo simulations predicted this regimen to achieve consistent areas under the curve of 91.9 mg·h/L (range: 76.3–106 mg·h/L) under all scenarios. Thus, this regimen was predicted to reliably achieve efficacious contezolid exposures independent of timing of switch from IV CZA to oral contezolid.IMPORTANCEThis study provides the population pharmacokinetic rationale for the dosage regimen of the intravenous (IV) prodrug contezolid acefosamil (CZA) followed by oral contezolid. We developed the first integrated population model for the pharmacokinetics of the MRX-1352 intermediate prodrug, active contezolid, and its main metabolite MRX-1320 based on data from three clinical studies in healthy volunteers and phase 2 patients. The proposed regimen was predicted to reliably achieve efficacious contezolid exposures independent of timing of switch from IV CZA to oral contezolid.

项与 Worldwide Clinical Trials LLC 相关的新闻（医药）

2024-02-09

·Pharmaceutical Technology

Pharma and biotech concerned about the stability of large CROs, survey finds

In the survey, 80% of respondents no longer favoured the ‘one-stop shop’ model of large CROs. Image credit: Shutterstock / Sai Thaw Kyar. Pharma and biotechs have shared concerns about working with large CROs, saying that the ‘one-stop shop’ model is no longer a cost-effective business model. CRO Worldwide Clinical Trials conducted a survey that asked pharma and biotech companies for their thoughts on both large and midsize CROs. The industry has been rocky for some time, with Covid-19 having a big impact on outsourcing relationships. In the survey, nearly 80% of respondents felt the ‘one-stop-shop’ claim of large CROs is not a cost-effective business model and 50% of respondents said that the instability of large CROs had impacted their willingness to partner due to project team disruptions, lack of access to top talent, poor service delivery, and more. Other concerns raised by respondents included lack of personalised attention (75%), apprehension about high development costs (71%) and team disruptions within the CRO impacting turnaround times (70%). Meanwhile, the survey found that midsize CROs are seen more favourably, citing agility (83%), personalised attention (79%), and access to senior-level scientific and medical expertise (80%) as reasons why they prefer to work with them. See Also: LCAR-G08 by Legend Biotech for Pancreatic Cancer: Likelihood of Approval Worldwide Clinical Trials CEO Peter Benton said that sponsors are looking for transparent communication, responsiveness, flexibility, and proactive personalised attention. “Customers don’t want to be treated like just a number. Some of them have only one asset and they need to be treated like they are our only customer. They want true partnerships, including regular access to and assurance from our senior leaders and scientific experts,” said Benton. “Clinical research is moving fast into new areas – and emerging to midsize biotechs need our collective experience. They also need a CRO partner that is flexible – one that is willing and able to adapt when needed – and one that they can have confidence in.” The data also revealed that there is due to be a shift of 41% to 46% (net gain of 5%) from large to midsize CROs over the next three years. Samir Shah, principal of Shah Pharma Consulting Services, said that the findings by Worldwide Clinical Trials are supported by a McKinsey & Company report that includes data from the biotech segment and provides insights on how CROs can improve their partnership models.

2022-07-13

·BioSpace

U.S. Alliance Pharma Acquires U.K.-based LGC’s Drug Development Solutions (DDS) Business

Expands bioanalytical services to include many emerging areas worldwide MALVERN, Pa.--(BUSINESS WIRE)-- Alliance Pharma (Alliance), a U.S. leader in small and large molecule bioanalytical services in the pharmaceutical and biopharmaceutical industry, today closed on the purchase of Drug Development Solutions (DDS), a U.K.-based bioanalytical and material science testing contract research organization (CRO), from LGC. Ampersand Capital Partners, a global healthcare private equity firm, and KKR & Co. Inc. (KKR) (NYSE:KKR), a leading global investment firm, are equal shareholders in the combined company. This transaction expands bioanalytical, analytical material testing and laboratory capabilities internationally for the biopharma and pharma industry, including areas of cell and gene therapy, next-generation biologics, material sciences and protein characterization. “Together, Alliance and DDS will partner with customers on a global basis to provide advanced bioanalytical and analytical material services for both large and small molecules, particularly supporting many emerging bioanalytical and analytical science areas the industry needs right now,” said Alliance Chairman of the Board and a Partner at Ampersand Capital Partners Dave Patteson. “Alongside Alliance’s bioanalytical expertise, DDS adds an unrivalled breadth and depth of expertise in bioanalysis and analytical and materials science as well as two state-of-the-art analytical labs in Cambridge (Fordham), U.K., and Sandwich, Kent, U.K. Their Cambridge facility is one of the largest bioanalytical centers in the world with about 270 employees.” This acquisition positions Alliance to become an international bioanalytical service provider for all therapeutic modalities. About Alliance Pharma Founded in 2008, Alliance is a contract research organization (CRO) in Malvern, PA, just outside of Philadelphia that specializes in advanced bioanalytical research services for both small and large molecule drugs, as well as drug metabolism studies to support pharmaceutical and biotechnology companies’ drug discovery and development programs. Alliance’s mission is to build a trusted partnership with our clients to support their successful drug development programs. Our business philosophy is based on a foundation of trust, professional ethics, scientific excellence and regulatory compliance. About Drug Development Solutions (An LGC Business Unit) DDS’s Bioanalytical solutions include liquid-chromatography mass spectrometry (LC-MS) and immunoassay bioanalysis, to provide data for pharmacokinetics, immunogenicity, pharmacodynamics and cell-based assays supporting all phases of drug development to GCP and GLP standards. Its Analytical Materials Sciences solutions provides specialist testing of raw materials, formulated products, packaging and medical devices for trace impurities, contamination, degradation and quality control to support CMC (Chemistry Manufacturing and Control) analytical testing to GMP (Good Manufacturing Practice) standard. About Ampersand Capital Partners Founded in 1988, Ampersand is a middle market private equity firm with more than $2 billion of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm’s core healthcare sectors. Additional information about Ampersand is available at ampersandcapital.com. About KKR KKR is a leading global investment firm that offers alternative asset management as well as capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at and on Twitter @KKR_Co. View source version on businesswire.com: Contacts Lindsey Langemeier SCORR Marketing 402-405-4269 lindsey@scorrmarketing.com Source: Alliance Pharma View this news release online at:

基因疗法小分子药物并购合作

2022-06-24

·PRNewswire

Global Therapeutics Contact Lens Market Report to 2027 - by Material Type, Application, Distribution Channel and Region

DUBLIN, June 24, 2022 /PRNewswire/ -- The "Global Therapeutics Contact Lens Market, By Material Type (Balafilcon, Lotrafilcon, Methafilcon, Senofilcon, Others), By Application (Pain Relief, Corneal Healing, Sealing & Protection, Others), By Distribution Channel, By Region, Competition Forecast & Opportunities, 2027" report has been added to ResearchAndMarkets.com's offering. The Global Therapeutics Contact Lens Market is expected to grow at a steady CAGR of 12.10% to reach USD5788.23 million by 2027 on the back of the rise in the number of eye treatment surgeries happening across the globe. Also, the increased prevalence of myopia and other eye disorders and the growing use of advanced technologies for eye treatment are other prominent factors driving the Global Therapeutics Contact Lens Market. Contact lenses are safer and can provide effective vision correction compared to traditional eyewear. The government of several countries is investing heavily to develop the healthcare sector and emphasize the importance of vision care. They are launching awareness camps and campaigns to increase the awareness in the people about advanced eye care. Also, an increase in the number of myopia and other eye disorders is expected to create significant opportunities for the Global Therapeutics Contact Lens Market in the forecast period. The Global Therapeutics Contact Lens Market is segmented into material type, application, distribution channel, regional distribution, and competitive landscape. Based on material type, the market is divided into balafilcon, lotrafilcon, methafilcon, senofilcon, and others. The senofilcon material dominated the market in 2021 and accounted for 43.15% of the overall market share. This segment is expected to maintain its dominance throughout the forecast period. Senofilcon keeps the eye white and healthy and provides more relief for ocular discomfort. Some of the key players operating in the Global Therapeutics Contact Lens Market are Johnson & Johnson, Alcon, Inc, Bausch Health Companies, Inc, EssilorLuxottica S.A., Carl Zeiss Meditec AG, SynergEyes Inc., X-Cel Specialty Contacts., CooperVision, Inc., Hoya Corporation., SEED Co., Ltd, among others. Years considered for this report: Historical Years: 2017-2020 Base Year: 2021 Estimated Year: 2022 Forecast Period: 2023-2027 Objective of the Study: To analyze the historical growth and the market size of the Global Therapeutics Contact Lens Market from 2017 to 2021. To estimate and forecast the market size of the Global Therapeutics Contact Lens Market from 2023 to 2027 and growth rate until 2027. To classify the Global Therapeutics Contact Lens Market based on material type, application, distribution channel, regional distribution, and competitive landscape. To identify drivers and challenges for the Global Therapeutics Contact Lens Market. To examine competitive developments such as expansions, new product launches, mergers, and acquisitions, etc., in the Global Therapeutics Contact Lens Market. To conduct pricing analysis for the Global Therapeutics Contact Lens Market. To identify and analyze the profile of leading players operating in the Global Therapeutics Contact Lens Market. Key Topics Covered: 1. Product Overview 2. Research Methodology 3. Executive Summary 4. Impact of COVID-19 on Global Therapeutics Contact Lens Market 5. Voice of Customer 5.1. References for Using Therapeutic Contact Lens Across Gender 5.2. Reasons for Using Therapeutic Contact Lens 5.3. Frequency of Therapeutic Contact Lens Usage 5.4. Preferred Point of Purchase 5.5. Factors Influencing Purchase Decision 5.6. Sources of Information 5.7. Barriers to Adoption of Therapeutic Contact Lens 5.8. Brand Awareness 6. Clinical Trials Analysis 6.1. Ongoing Clinical Trials 6.2. Completed Clinical Trials 6.3. Terminated Clinical Trials 7. Patent Analysis 7.1. Patent Granted (2017-2021) 7.2. Patent Applications Filed 8. Global Therapeutics Contact Lens Market Outlook 8.1. Market Size & Forecast 8.1.1. By Value 8.2. Market Share & Forecast 8.2.1. By Material Type (Senofilcon, Balafilcon, Lotrafilcon, Methafilcon, Others) 8.2.2. By Application (Drug Delivery, Corneal Healing, Pain Relief, Sealing & Protection, Drug Delivery, Others)) 8.2.3. By Distribution Channel (Hospitals & Clinics, Online, Optical Retail Stores) 8.2.4. By Company (2021) 8.2.5. By Region 8.3. Market Map 9. North America Therapeutics Contact Lens Market Outlook 10. Europe Therapeutics Contact Lens Market Outlook 11. Asia Pacific Therapeutics Contact Lens Market Outlook 12. South America Therapeutics Contact Lens Market Outlook 13. Middle East and Africa Therapeutics Contact Lens Market Outlook 14. Market Dynamics 14.1. Drivers 14.2. Challenges 15. Market Trends and Developments 16. Competitive Landscape 16.1. Johnson & Johnson 16.2. Alcon, Inc 16.3. Bausch Health Companies, Inc. 16.4. EssilorLuxottica S.A 16.5. Carl Zeiss Meditec AG 16.6. SynergEyes Inc. 16.7. X-Cel Specialty Contacts 16.8. CooperVision, Inc. 16.9. Hoya Corporation 16.10. SEED Co., Ltd. 17. Strategic Recommendations For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

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