Clinical Trials Arena

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ASCO25: Novartis hopes Scemblix becomes new standard for CML-CP

6 days ago | clinicaltrialsarena.com | Abigail Beaney

Novartis is hoping that Scemblix (asciminib) will become the physician’s first choice of therapy for chronic myeloid leukaemia in chronic phase (CML-CP) after it has shown to be more tolerable than the standard of care (SOC) in a Phase IIIb trial. Scemblix is a first-in-class STAMP inhibitor which received accelerated approval by the US Food and Drug Administration (FDA) in 2021 in previously treated CML in adult patients.
ASCO25: Merck KGaA’s ADC shows safety and tolerability in colorectal cancer trial

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Merck KGaA’s antibody-drug conjugate (ADC), precemtabart tocentecan, has shown to be safe and tolerable in a Phase Ib trial. The ongoing PROCEADE-CRC-01 study (NCT05464030) is investigating the dose, safety and tolerability of intravenous (IV) precemtabart tocentecan in approximately 200 patients with metastatic colorectal cancer (mCRC). The study is also looking at early signs of efficacy. Two doses of the drug, 2.4mg/kg and 2.8mg/kg, are being investigated, with patients dosed every three weeks.
Intellia stock dips following safety event in Phase III gene therapy trial

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Intellia Therapeutics’ stock has fallen nearly 23% following an announcement that a patient in its Phase III trial for a gene therapy targeting transthyretin amyloid (ATTR) cardiomyopathy suffered a serious adverse event (AE). In a filing by the Securities and Exchange Commission (SEC), the company reported that one patient experienced Grade 4 liver transaminase elevations after treatment with nexiguran ziclumeran (nex-z) in the Phase III MAGNITUDE trial (NCT06128629).
Patient-centric approaches thrive on wearables and remote access in trials

1 week ago | clinicaltrialsarena.com | Irena Maragkou

A transformative application of artificial intelligence (AI) in drug development lies in its potential to match the right patient population with the right drugs, and this should be a primary focus of innovation efforts, said experts at a recent oncology-focused conference.
GSK and Spero halt UTI antibiotic trial early due to high efficacy

1 week ago | clinicaltrialsarena.com | Abigail Beaney

GSK and Spero Therapeutics’ Phase III trial of their oral antibiotic for complicated urinary tract infections (cUTI) will end early after successfully meeting its primary endpoint. The decision to end the trial, which was investigating tebipenem HBr, was made after a recommendation from an Independent Data Monitoring Committee (IDMC) based on pre-specified interim analysis from the pivotal PIVOT-PO trial (NCT06059846).
Infectious diseases and community research: How to improve reach and results

1 week ago | clinicaltrialsarena.com | Miranda McLaren

Global immunization programs have successfully eradicated or controlled many infectious diseases throughout history. However, challenges like antimicrobial resistance, climate change, and the potential threat of biological warfare are continuously reshaping the global health landscape. As these factors evolve, new pathogens or mutated strains of existing ones may emerge.
Mapping out opportunities to reduce emissions in clinical trials

1 week ago | clinicaltrialsarena.com | Irena Maragkou

Roche is committed to reach net zero greenhouse gas emissions across Scope 1, 2 and 3 by 2045, with interim targets by 2029, says Edward Owen, Therapeutic Area Director of Oncology and Early Clinical Development at Genentech. A 90% net zero pledge means a reduction of emissions by 90%, Owen explained, while the remaining 10% of emissions are offset by sequestering greenhouse gases from the atmosphere.
Gilgamesh’s psychedelic touts 94% remission rate in depression study

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Gilgamesh Pharmaceuticals’ psychedelic therapy has boasted a 94% depression remission rate after 29 days in a Phase IIa study. The trial (NCT06236880) investigated the efficacy, safety and durability of GM-2505, a novel, rapid-acting 5-HT2A receptor agonist and 5-HT releaser in patients with moderate-to-severe major depressive disorder (MDD).
Psychedelic drug developers redesign trials to avoid Lykos faux pas

1 week ago | clinicaltrialsarena.com | Abigail Beaney

In 2024, Lykos Therapeutics looked set to have the first psychedelic approved by the US Food and Drug Administration (FDA), an MDMA therapy for post-traumatic stress disorder (PTSD). However, the regulator rejected the drug’s approval application, sending ripples through this field. Other companies in the psychedelic drugs sector then started to see if they might stumble over the same hurdle.
Capitalising on UK’s goal to become a world-leading clinical trial destination

1 week ago | clinicaltrialsarena.com | Frankie Fattorini

Representatives of industry and regulation will meet in June to discuss paths forward for the UK’s clinical trials sector following its recent reform and revitalisation. Delegates convene in London on 10–11 June at the 12th annual Outsourcing in Clinical Trials UK & Ireland conference to explore the challenges, innovations, and opportunities of trial outsourcing.