Clinical Trial News
Bayer's Future Clinical Trials Project Streamlines Drug Development in Finland
- Bayer's Future Clinical Trials project in Finland aimed to address the complexity and cost of clinical trials using data-driven and patient-centric approaches.
- The project leveraged Finland's robust healthcare data and innovation ecosystem to develop new technologies and optimize clinical trial efficiency.
- The initiative resulted in solutions like an external control arm derived from Finnish real-world data, enhancing patient selection and protocol optimization.
- Business Finland supported the project, fostering collaboration and showcasing Finland as an attractive location for pharmaceutical R&D and clinical trials.
Acelyrin's Izokibep Shows Positive Phase 2b/3 Results in Psoriatic Arthritis
- Acelyrin's izokibep demonstrated positive results in a Phase 2b/3 trial for psoriatic arthritis (PsA), showing efficacy and safety over 16 weeks.
- The trial evaluated izokibep at different subcutaneous doses (160 mg QW, 160 mg Q2W, and 80 mg Q4W) against placebo in 351 adult patients with active PsA.
- Izokibep, a small protein therapeutic, inhibits IL-17A and is being assessed in multiple late-stage trials for immune-mediated diseases, including hidradenitis suppurativa and uveitis.
- Detailed findings will be presented at the European Alliance of Associations for Rheumatology (EULAR) Congress on June 15, 2024, by Dr. Philip Mease.
Highlighted Clinical Trials:
GLP-1 Weight Loss Drugs Like Ozempic Show Promising Cancer Prevention Benefits
- Breakthrough research reveals GLP-1 receptor agonists like Ozempic and Wegovy may reduce obesity-related cancer risk by 19% and bowel cancer risk by up to 50%, suggesting potential cancer prevention applications.
- A landmark study analyzing over 34,000 obese patients found those using weight-loss injections for at least a year had comparable cancer risk reduction to bariatric surgery patients, despite the latter losing significantly more weight.
- Scientists believe GLP-1 drugs may work through multiple mechanisms beyond weight loss, including reducing inflammation, triggering cancer cell death, and decreasing alcohol consumption and smoking behaviors.
Takeda's TAK-861 Shows Promising Results in Phase 2b Trial for Narcolepsy Type 1
- Takeda's investigational oral orexin receptor 2 agonist TAK-861 demonstrated statistically significant improvements across all primary and secondary endpoints in a Phase 2b trial for narcolepsy type 1.
- The 8-week study involving 112 patients showed sustained efficacy in reducing excessive daytime sleepiness and cataplexy frequency, with most participants achieving normative ranges for key measures.
- Based on these promising results, Takeda plans to initiate global Phase 3 trials in the first half of 2024, supported by the FDA's Breakthrough Therapy designation for TAK-861.
Highlighted Clinical Trials:
Takeda
Posted 1/9/2023
Capricor's CAP-1002 Shows Sustained Benefits in Duchenne Muscular Dystrophy After 3 Years
- Capricor Therapeutics' CAP-1002 demonstrates sustained benefits in Duchenne muscular dystrophy (DMD) patients after three years of treatment in the HOPE-2 open-label extension study.
- The study showed a statistically significant reduction in the decline of upper limb function (PUL 2.0) and stabilization of left ventricular ejection fraction (LVEF) compared to an external comparator.
- CAP-1002 continues to exhibit a consistently well-tolerated safety profile throughout the extension study, supporting its potential as a long-term treatment for DMD.
- Topline results from the Phase 3 HOPE-3 pivotal trial are expected in the fourth quarter of 2024, with potential for BLA submission to the FDA.
Highlighted Clinical Trials:
Capricor Inc.
Posted 4/4/2018
Capricor Inc.
Posted 1/7/2016
Capricor Inc.
Posted 6/22/2022
Capricor Inc.
Posted 8/5/2020
Uproleselan Shows Clinically Meaningful Improvement in Primary Refractory AML
- GlycoMimetics' uproleselan demonstrated a significant improvement in median overall survival (mOS) for patients with primary refractory AML, with mOS reaching 31.2 months compared to 10.1 months in the placebo arm.
- The Phase 3 study results indicate that uproleselan has the potential to address the unmet need for new treatment options in primary refractory AML, irrespective of backbone chemotherapy.
- GlycoMimetics is planning to engage with regulators and the National Cancer Institute (NCI) to discuss potential paths forward for uproleselan in multiple AML settings.
- Adverse events associated with uproleselan were consistent with the known side effect profiles of the chemotherapy regimens used in the study, supporting its safety profile.
CARsgen's Satri-cel Shows Promise in Phase 1 Trial for Gastrointestinal Cancers
- Final results from the Phase 1 trial of satricabtagene autoleucel (satri-cel) demonstrate promising efficacy and manageable safety in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly gastric and gastroesophageal junction cancers.
- The groundbreaking CAR T-cell therapy targeting Claudin18.2 represents a significant advancement in solid tumor treatment, with results simultaneously published in Nature Medicine and presented at the 2024 ASCO Annual Meeting.
- Satri-cel has received multiple regulatory designations including RMAT designation from the FDA and PRIME eligibility from the EMA, positioning it as a potential first-in-class therapy globally for Claudin18.2-positive solid tumors.
Highlighted Clinical Trials:
Peking University
Posted 3/26/2019
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
CARsgen Therapeutics Co., Ltd.
Posted 10/23/2020
CARsgen Therapeutics Co., Ltd.
Posted 7/11/2023
U.S. Clinical Trials Begin for Twice-Yearly HIV Prevention Injection
Two clinical trials have launched to evaluate a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The studies aim to assess the safety, acceptability, and pharmacokinetics of lenacapavir, an antiretroviral drug administered by injection every six months. These trials are part of efforts to include underrepresented populations in HIV clinical research.
Highlighted Clinical Trials:
Gilead Sciences
Posted 11/17/2023
Gilead Sciences
Posted 12/13/2023
Sanofi Highlights Phase 3 Sarclisa Data in Multiple Myeloma Treatment
Sanofi has recently showcased promising Phase 3 data for its Sarclisa treatment in multiple myeloma, aiming to compete with J&J's Darzalex.
Crinetics Reports Promising Results for Atumelnant in Treating CAH and ACTH-Dependent Cushing’s Syndrome
Crinetics Pharmaceuticals announced positive initial findings from its Phase 2 TouCAHn study for congenital adrenal hyperplasia (CAH) and Phase 1b/2a study for ACTH-dependent Cushing’s syndrome (ADCS) at ENDO 2024. Atumelnant, a novel ACTH receptor antagonist, showed significant reductions in key biomarkers, with all participants achieving normal levels of androstenedione and cortisol, indicating its potential as an effective treatment.
Highlighted Clinical Trials:
Crinetics Pharmaceuticals Inc.
Posted 10/12/2023
Crinetics Pharmaceuticals Inc.
Posted 7/3/2023