Clinical Trials Arena

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Eli Lilly’s shares up as oral GLP-1RA scores in first Phase III trial

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Eli Lilly’s Phase III trial with its oral weight loss pill, orforglipron, has met its primary endpoint, reducing A1C levels by up to 1.6%. In the first of several readouts expected from a Phase III programme, Lilly said its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) demonstrated significant efficacy while maintaining a safety profile consistent with subcutaneously delivered GLP-1RA drugs. Eli Lilly’s stock jumped up by 13.8% at market open today (17 April).
Glycomine raises $115m to advance rare disease therapy into Phase IIb

1 week ago | clinicaltrialsarena.com | Jenna Philpott

Glycomine has raised $115m in Series C financing to advance its lead investigational therapy, GLM101, into a Phase IIb clinical trial for an ultra-rare disorder. GLM101 is being developed as a treatment for phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG), a rare and life-threatening genetic disorder with no approved treatments. Glycomine is currently conducting an open-label Phase II clinical trial (NCT06657859) at sites in Europe and the US, with 20 patients enrolled to date.
Podcast: What’s next for the pharma tariffs?

1 week ago | clinicaltrialsarena.com | Jenna Philpott |Abigail Beaney |Manasi Vaidya

The US government has signalled a major shift in its trade policies in recent weeks, with several announcements detailing plans for import tariffs. While President Trump has made several announcements on tariffs since he took office, things accelerated on 2 April, which was christened as ‘Liberation day’ when the administration announced reciprocal tariffs for a number of countries.
FDA clears eGenesis’ genetically engineered porcine liver for Phase I trial

1 week ago | clinicaltrialsarena.com | Ross Law

eGenesis has gained US Food and Drug Administration (FDA) clearance on an investigational new drug (IND) application for a genetically engineered porcine (pig) liver. The organ is designed for use with OrganOx’s extracorporeal liver cross-circulation (ELC) system for patients with acute-on-chronic liver failure (ACLF). The biotech and medtech companies entered an exclusive clinical co-development agreement last year to advance their respective technologies in combination.
Synthetic control arms: full impact yet to be realised

1 week ago | clinicaltrialsarena.com | VMS Engage |Robert Barrie

Amid the brighter spotlights being directed at data use in clinical trials, synthetic control arms represent a unique approach. Synthetic control arms use statistical methods to create a virtual control group based on observed data from a multitude of sources. Their utilisation is especially important in indications with inadequate standard-of-care and in diseases with small patient populations.
BMS’ Camzyos flops in Phase III non-obstructive hypertrophic cardiomyopathy trial

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Bristol Myers Squibb’s (BMS) Phase III trial investigating Camzyos (mavacamten) in patients with non-obstructive hypertrophic cardiomyopathy (nHCM) has failed to meet its dual primary endpoints. In the ODYSSEY-HCM (NCT05582395) trial, the cardiac myosin inhibitor did not show a benefit compared to placebo in either the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) or peak oxygen consumption (pVO2) after 48 weeks.
Pfizer drops obesity pill development after liver injury report

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Pfizer has terminated the development of its oral obesity candidate danuglipron after a patient on a clinical trial with the drug suffered a liver injury. The oral glucagon-like peptide-1 receptor agonist (GLP-1RA) was being investigated in chronic weight management in several Phase I and Phase II trials. Two Phase I studies (NCT06567327 and NCT06568731) met pharmacokinetic (PK) endpoints and determined a formulation and dose for danuglipron.
How can pharma manage rising trial costs?

1 week ago | clinicaltrialsarena.com | Abigail Beaney

Clinical trial costs have been rising year-on-year, with companies working to balance the scales and keep studies running despite declining investment. The pharma and biotech sector appeared to be jumping into action during the 2021 financial boom, however, this was followed by a drought of financing in the three years since. At the same time, costs have been rising for research, meaning companies who are yet to market a product are caught in the middle of a perfect storm.
Shaping the future of clinical trials in the EU

1 week ago | clinicaltrialsarena.com | Irena Maragkou

Later this month, experts from healthcare companies, contract research organisations (CROs), and patient advocacy groups will gather to do a deep-dive into current trends and innovations in clinical trial operations at the Outsourcing in Clinical Trials (OCT) Europe meeting in Barcelona, Spain. Industry experts will gather at the 15th Annual OCT Europe meeting, to discuss not just the challenges in the clinical trial industry, but also patient perspectives and technology advancements.
Alzheon’s Alzheimer’s pill fails in Phase III trial

1 week ago | clinicaltrialsarena.com | Abigail Beaney

US-based Alzheon’s Alzheimer’s disease pill has failed in a Phase III trial, but the biopharma still holds hope for the drug after seeing signals in a subgroup of patients.