Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (CAT) (a Multicenter Study)

Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

Start Date01 Feb 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

[+3]

NCT06444867 / RecruitingPhase 1

An Open-label, Phase 1b, Multi-site Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following a Single Dose of LEO 158968 in Subjects With Gout Flares

The main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares.

Start Date01 Nov 2024

Sponsor / Collaborator

Leo Pharma, Inc.

NCT06311682 / RecruitingPhase 3

A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.
The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.
The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

Start Date10 Jun 2024

Sponsor / Collaborator

Leo Pharma, Inc.

100 Clinical Results associated with LEO Fondet

0 Patents (Medical) associated with LEO Fondet

412

Literatures (Medical) associated with LEO Fondet

31 Dec 2024·Journal of Dermatological Treatment

Patient preferences for treatment attributes in moderate-to-severe atopic dermatitis: a discrete choice experiment

Article

Author: Feldman, Steven R ; Meng, Yan ; Gallant, Kirsten ; Claxton, Ami J ; Guerin, Annie ; Gauthier-Loiselle, Marjolaine ; Hazra, Nisha C ; Balu, Sanjeev

Purpose: Evidence on treatment preferences of patients with moderate-to-severe atopic dermatitis (AD) in the United States (US) is limited and an assessment of treatment preferences in this group is warranted.Materials and methods: An online discrete choice experiment survey was conducted (June 2023) among US adults with self-reported moderate-to-severe AD or experience with systemic therapy who had inadequate response to topical treatments. Preference weights estimated from conditional logistic regression models were used to calculate willingness to trade off and attributes' relative importance (RI).Results: Participants (N = 300; mean age: 45 years; 70% females; 52% systemic therapy experienced) preferred treatments with higher efficacy, lower risk of adverse events (AEs), and less frequent blood tests (p < .05). Treatment attributes, from high to low RI, were itch control (38%), risk of cancer (23%), risk of respiratory infections (18%), risk of heart problems (11%), sustained improvement in skin appearance (5%), blood test frequency (3%), and frequency and mode of administration (2%); together, AE attributes accounted for more than half of the RI.Conclusions: Participants preferred AD treatments that maximize itch control while minimizing AE risks, whereas mode of administration had little impact on preferences. Understanding patients' preferences may help improve shared decision-making, potentially leading to enhanced patient satisfaction with treatment, increased engagement, and better clinical outcomes.

08 Aug 2024·British Journal of Dermatology

714 - Real-world effectiveness of persistent tralokinumab use on clinician and patient-reported outcomes in patients with atopic dermatitis in the CorEvitas atopic dermatitis registry

Author: Silverberg, Jonathan ; Pugach, Oksana ; Jean Choi, C ; Balu, Sanjeev ; Simpson, Eric ; Li, Alvin ; Schneider, Shannon

AbstractIntroduction/BackgroundTralokinumab is a high-affinity monoclonal antibody that specifically targets IL-13, a driver of inflammation in atopic dermatitis (AD). The ECZTRA 1, 2, 3, and 6 trials demonstrated that tralokinumab is efficacious and safe in adults and adolescents; however, real-world evidence on tralokinumab use is limited.ObjectivesTo assess the change from baseline in clinician-assessed and patient-reported outcomes (PROs) among US adults with AD following 6 months of persistent tralokinumab use after treatment initiation in the CorEvitas AD registry.MethodsThe CorEvitas AD Registry is a prospective, non-interventional registry launched in July 2020 for adult AD patients under the care of a licensed dermatologist or qualified dermatology practitioner. This analysis includes US patients enrolled in the CorEvitas AD registry who initiated tralokinumab between February 1, 2022 and May 31, 2023, had baseline data, and were persistent on tralokinumab at the 6-month follow-up (defined as a visit occurring 5 to 9 months from tralokinumab initiation). Baseline data were summarized using descriptive statistics and stratified by advanced systemic therapy (AST) experience (defined as any previous history of dupilumab, abrocitinib, or upadacitinib). Outcome measures collected included: validated Investigator’s Global Assessment for atopic dermatitis (vIGA-ADTM), ≥50%/≥75% improvement in Eczema Area and Severity Index (EASI) (EASI-50/75), ≥4-point improvement in Dermatology Life Quality Index (DLQI), ≥3-point improvement in mean weekly pruritis numerical rating scale, and mean change in Work Productivity and Activity Impairment (WPAI).ResultsAmong the 60 patients in this analysis, the mean age was 49.1 years and mean AD duration was 15.0 years. The majority of patients were female (34/60, 56.7%), White (51/60, 85.0%), worked full-time (38/60, 63.3%), and AST-naïve (44/60, 73.3%). At baseline, the majority of patients had moderate-to-severe AD based on EASI (EASI≥ 7, 40/60, 67%) and vIGA-ADTM (vIGA-ADTM 3: 50/60, 83.3%; vIGA-ADTM 4: 4/60, 6.7%). Disease severity was lower in AST-experienced patients, all of whom were dupilumab-experienced. A notable proportion of patients experienced improvements in clinician-assessed endpoints and PROs from baseline to 6 months: vIGA-ADTM ≤1 from 6.7% (4/60) to 55.0% (33/60), EASI ≤7 from 33.3% (20/60) to 85.0% (51/60), and DLQI ≤5 from 38.3% (23/60) to 66.7% (40/60).Among patients with EASI ≥7.1 at baseline, 85.0% (34/40) achieved EASI-50 (AST-naïve: 90.9%, 30/33; AST-experienced: 57.1%, 4/7) and 77.5% (31/40) achieved EASI-75 (AST-naïve: 84.8%, 28/33; AST-experienced: 42.9%, 3/7) at the 6-month follow-up. In patients with vIGA-ADTM of 3 or 4 at baseline, 79.6% (43/54) achieved EASI-50 (AST-naïve: 83.3%, 35/42; AST-experienced: 66.7%, 8/12) and 66.7% (36/54) achieved EASI-75 (AST-naïve: 76.2%, 32/42; AST-experienced: 33.3%, 4/12) at follow-up. Among patients with baseline DLQI ≥4, 71.4% (30/42) achieved ≥4-point improvement at follow-up (AST-naïve: 78.1%, 25/32; AST-experienced: 50.0%, 5/10). Of patients with baseline mean weekly pruritus NRS ≥3, 69.8% (37/53) achieved ≥3-point improvement at follow-up (AST-naïve: 70.0%, 28/40; AST-experienced: 69.2%, 9/13). Among the 40 patients employed at both baseline and follow-up visit, improvements were reported in WPAI. Percent impairment at work due to AD decreased by 14.8% (95% CI: -25.6%; -3.9%) and percent overall work impairment due to AD decreased by 15.7% (95% CI: -26.4%; -5.0%). For all 60 patients, non-work activity impairment due to AD decreased by 14.5% (95% CI: -23.9%; -5.1%).ConclusionsIn this real-world study, patients with AD experienced notable improvements in both clinician-assessed and patient-reported outcomes after 6-months of persistent tralokinumab treatment, regardless of prior AST therapy use. All 16 AST-experienced patients had prior use of dupilumab. These findings support the therapeutic potential of tralokinumab for AD patients, highlighting the need for future studies with longer follow-up period and larger sample size.

08 Aug 2024·British Journal of Dermatology

652 - Tralokinumab real-world use in adults with atopic dermatitis: baseline characteristics of the first 100 patients recruited to the TRACE study in the United States

Author: Armstrong, April W ; Anastasiadou, Dimitra M ; Rodriguez, Adrian ; Bagel, Jerry ; Nguyen, Tien ; Rubin, Cory ; Schneider, Shannon ; Jarell, Abel ; Stinson, John

AbstractIntroduction/BackgroundTralokinumab is a fully human, high-affinity, monoclonal antibody that specifically neutralizes interleukin-13, a key driver of atopic dermatitis (AD) pathogenesis. Numerous clinical studies have established that tralokinumab is an efficacious treatment for patients with moderate-to-severe AD, along with having a favorable safety profile. However, there is a lack of evidence on tralokinumab use in routine clinical practice, where patient management may differ from that defined by clinical trial protocols.ObjectivesTRACE is a global, real-world study that aims to better understand the effectiveness, safety, and clinical use of tralokinumab in patients with AD in daily practice.MethodsTRACE is a global, observational, prospective, single-cohort study of tralokinumab-treated adults with moderate-to-severe AD. Overall, 11 countries across Europe, North America and the Middle East are participating. The primary objective of TRACE is to assess changes in clinical signs and symptoms of AD in patients treated with tralokinumab according to the nationally approved labels. Secondary objectives include safety, quality of life, patient-reported outcomes and treatment adherence. For this interim analysis, the objective was to report the baseline characteristics of the first 100 US patients.ResultsOverall, 55% of the first 100 US patients initiated on tralokinumab in the TRACE study were female; the majority (54%) were White, followed by 18% Black or African American and 12% Asian. Mean (standard deviation [SD]) age was 46.4 years (18.2) and body mass index was 28.6 kg/m2 (7.7). Patients had a mean disease duration of 13.9 years (SD 16.5), with 46% being biologic-naïve and 54% biologic-experienced. Most patients (88%) had moderate-to-severe AD, with a mean Investigator’s Global Assessment score of 3.2 (SD 0.8); mean Eczema Area and Severity Index was 15.4 (SD 7.9). A heavy symptomatic burden of disease was evident, with a mean eczema-related sleep numerical rating scale (NRS) of 4.2 (SD 3.3) and mean worst daily pruritus NRS of 6.1 (SD 2.6). Patients also reported a substantial impact of AD on quality of life; mean Dermatology Life Quality Index was 13.2 (SD 8.5). Almost one quarter (24%) of patients reported ≥1 atopic comorbidity, with asthma (12%), cardiovascular disease (8%) and autoimmune disease (6%) being the most frequent; 3% of patients had psychiatric illness.ConclusionsInitial findings showed that tralokinumab is being prescribed as a first-line biologic treatment option in the US in accordance with the label. Treated patients had a heavy burden of disease with considerable impact on quality of life.

News (Medical) associated with LEO Fondet

25 Oct 2024

·www.pharmaceutical-technology.com

LEO’s Adbry demonstrates long-term efficacy in atopic dermatitis

Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes that drive symptoms of atopic dermatitis. Credits: Evgeniia Primavera / Shutterstock. Leo Pharma has announced long term safety and efficacy data for its atopic dermatitis treatment, Adbry (tralokinumab-ldrm), demonstrating the drug’s ability to drive clear or almost clear skin for up to six years. Among patients enrolled in the Phase III ECZTEND study (NCT03587805) who have were on long-term (maintenance) treatment with Adbry, 92.9% of patients observed a reduction of at least 75% on the Eczema Area and Severity Index (EASI-75) at week 248. Additionally, 66.7% of patients achieved clear or almost clear skin, as assessed by the Investigator’s Global Assessment (IGA) scale. No new safety signals were identified. The results were presented in a poster at the Fall Clinical Dermatology Conference, which was held in Las Vegas, Nevada from 24-27 October. Adbry was approved by the US Food and Drug Administration (FDA) in 2021 for the treatment of adults with moderate-to-severe atopic dermatitis. The label was expanded in 2023 when Adbry gained an FDA approval for use in adolescents aged 12 and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. An alternative mode of administration after the approved by the FDA its single dose autoinjector in June 2024. In 2023, LEO generated net sales of DKK 11.4bn ($1.7bn), growth which was driven by growth of Adbry, as per the company’s 2023 annual results. GlobalData’s consensus forecasts project that Adbry will generate global sales of $1.3bn in 2030. See Also: Pharma companies must adapt to keep pace with AI developments, say experts AF stroke patients could benefit from earlier anticoagulant administration GlobalData is the parent company of Pharmaceutical Technology . Participants enrolled in the open label ECZTEND were previously assessed in multiple monotherapy and combination therapy studies of Adbry. Among these studies are the Phase III ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) studies of monotherapy Adbry and the Phase III ECZTRA 3 study (NCT03363854) of a Adbry/topical corticosteroid combination therapy. Patients were eligible to enroll in ECZTEND after completion of their respective parent trials regardless of their treatment response or whether they received Adbry or placebo treatment. Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes that drive symptoms of atopic dermatitis.

Phase 3Clinical ResultDrug Approval

17 Oct 2024

·endpts.com

BenevolentAI CEO is out after less than a year on the job

BenevolentAI’s CEO Joerg Moeller is stepping down effective immediately, the London biotech said Thursday, in the latest leadership shakeup atop the company. Since going public in early 2022 via a SPAC, BenevolentAI’s stock price has fallen over 90%. Its lead drug candidate fell short in a mid-stage eczema study last year, eventually leading to the program’s discontinuation. Moeller, formerly the global R&D head of Leo Pharma, was brought in to replace former CEO Joanna Shields in January. Now, less than 10 months into his tenure, BenevolentAI announced Moeller is headed out the door. The company didn’t give a reason for his exit, other than to say it was “immediate.” The company also didn’t name a replacement, though it did say that founder Ken Mulvany is now executive chairman. Mulvany rejoined BenevolentAI’s board in May, amid a broader boardroom battle . In a Thursday statement, Mulvany said the company has “only scratched the surface of our platform’s incredible potential.” Founded in 2013, BenevolentAI was one of the first biotech startups focused on artificial intelligence, alongside peers like Exscientia, Recursion Pharmaceuticals and Atomwise. Benevolent had pitched its AI approach as allowing it to slash preclinical costs and move faster. In its pitch to investors when it was going public via a SPAC, the biotech shared projections that its pipeline would grow from 12 programs in 2021 to more than 50 in 2026, eventually reaching 87 in 2030. It said its aim was to file one to two INDs per year for the next few years, increasing to a rate of two to three IND filings per year for 2027 to 2031. But those bold forecasts haven’t panned out. Today, BenevolentAI’s pipeline lists one program in the clinic and eight preclinical programs. It has slashed R&D and overall spending plans, including rounds of layoffs last May and this April . The company’s sole clinical-stage drug reported positive results from a healthy volunteer Phase 1 study earlier this year. And the company said last month it is in active out-licensing and partnership discussions around that molecule. BenevolentAI’s struggles are in line with several of its peers who have pitched R&D revolutions with their technology over the past decade. But the lead drug candidates from these AI-focused biotechs have fallen short in the clinic . Several of these original AI-focused biotechs have struggled to survive. Exscientia recently agreed to a merger deal with Recursion. Atomwise’s founding CEO Abe Heifets quietly left the company earlier this year with no announced successor, Endpoints News previously reported .

Phase 1Executive ChangeAcquisitionClinical ResultIPO

13 Oct 2024

·www.prnewswire.com

World Thrombosis Day raises global awareness of blood clot dangers through actionable initiatives

Help shape the future of women's health by taking the survey and supporting this global campaign in its eleventh year to improve care for at-risk patients. CHAPEL HILL, N.C., Oct. 13, 2024 /PRNewswire/ -- Today is World Thrombosis Day, a global campaign established by the International Society on Thrombosis and Haemostasis (ISTH) to engage the general public, healthcare providers and policymakers in spreading awareness of the signs, symptoms, risk factors and prevention of blood clots. This initiative aims to reduce the alarming statistic that 1 in 4 deaths are related to conditions associated with thrombosis. The campaign has partnered with more than 6,000 organizations worldwide to implement impactful initiatives. This year, World Thrombosis Day emphasizes the impact on women's health with the launch of a new global survey aimed at understanding women's awareness of their health risks. The initiative seeks to collect vital information to improve outcomes for women at risk of blood clots during pregnancy, postpartum, and other critical life stages. The survey is available in eleven languages to maximize accessibility and global participation. [Click to take the survey.] Blood clots in the legs and lungs, known as deep vein thrombosis (DVT) and pulmonary embolism (PE)—together referred to as venous thromboembolism (VTE)—are the third leading cause of cardiovascular deaths worldwide. World Thrombosis Day focuses on education about VTE, with particular attention to the unique health considerations that women face. "Understanding the risks of blood clots is crucial, as one in four people die worldwide from conditions caused by thrombosis. Raising awareness about VTE can ensure better care for those at risk," said Lana Castellucci, M.D., chair of the World Thrombosis Day Steering Committee. "This year, we are particularly focused on women's health and thrombosis. By gathering data through this survey, we aim to understand women's experiences with VTE education during pregnancy and postpartum and hope to empower women with knowledge and improve health outcomes for themselves and their families." World Thrombosis Day has also collaborated closely with corporate supporters, including The Bristol Myers Squibb Pfizer Alliance, Cardinal Health, Inari, Leo Pharma, Penumbra, Regeneron, and Viatris, to enhance the impact of the 2024 campaign, ensuring a comprehensive initiative. To learn more about blood clots, visit and stay tuned for updates on social media with #WTDay24. About the International Society on Thrombosis and Haemostasis (ISTH) Founded in 1969, the ISTH is the leading worldwide medical and scientific professional Society dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis. ISTH is an international medical-scientific professional membership organization with more than 7,000 clinicians, researchers, and educators working together to improve the lives of patients in more than 124 countries around the world. Among its highly regarded activities and initiatives are education and standardization programs, research activities, meetings and congresses, peer-reviewed publications, expert committees, and World Thrombosis Day on 13 October. Visit ISTH online at . SOURCE International Society on Thrombosis and Haemostasis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with LEO Fondet

100 Translational Medicine associated with LEO Fondet

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Pipeline Snapshot as of 15 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Azelaic Acid	Rosacea More	Approved
Alfacalcidol ( VDR )	Chronic Kidney Disease-Mineral and Bone Disorder More	Approved
Calcipotriene ( VDR )	Psoriasis More	Approved
Tralokinumab ( IL-13 )	Dermatitis More	Approved
Sodium Fusidate	Bacterial Infections More	Approved

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