Clinical trial

New analysis suggests that the Moderna Covid-19 vaccine is highly effective against circulating variants of concern, including in a vaccine effectiveness study conducted in partnership with Kaiser Permanente Southern California (KPSC) and in a separate recent publication by the US Centers for Disease Control and Prevention (CDC).   Additionally, the company shared a new analysis of follow-up through one year in […]

Beckley Psytech has dosed the first patient in a world-first clinical trial exploring the effects of psilocybin for treating Short-lasting Unilateral Neuralgiform Headache Attacks (SUNHA).   The outcome of the Phase Ib study, with proof-of-concept efficacy data, is expected to be available in early 2022. The clinical trial is being conducted as part of Beckley Psytech’s ongoing collaboration […]

New data from the Navigator Phase III trial showed that AstraZeneca and Amgen’s tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps.1   Tezepelumab is a potential first-in-class treatment that acts by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine, and has the potential to treat a […]

Massachusetts-headquartered Fulcrum Therapeutics has announced positive interim results from the ongoing single and multiple-ascending dose (SAD and MAD) Phase I trial with FTX-6058 in healthy adult volunteers. FTX-6058 is an investigational, potent and selective small molecule inhibitor of EED designed to increase the expression of fetal hemoglobin (HbF) with the potential to treat hemoglobinopathies, such […]

BlueRock Therapeutics has been granted Fast Track designation by the US Food and Drug Administration (FDA) for DA01 for advanced Parkinson’s disease (PD). DA01, BlueRock’s pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase I study. “Receiving Fast Track Designation from the FDA is an important step, which will help us further […]

F-star Therapeutics has dosed the first patients in a Phase I clinical trial, with FS222, a CD137/PD-L1 bispecific antibody. IONTAS applied its proprietary technology to generate a component utilised within FS222, which was subsequently licenced to F-star. António Parada, CEO at IONTAS, commented: “We are delighted with the progress of this molecule, the platform offered […]

Scohia has presented the results of a Phase I clinical trial for SCO-267, an orally bioavailable GPR40 full agonist, at the Virtual Scientific Sessions of the American Diabetes Association. Free fatty acid receptor 1 (GPR40) is a G protein-coupled receptor expressed in pancreatic islet and enteroendocrine cells, and SCO-267 is potentially a first in class […]

Eli Lilly’s tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 receptor agonist (GLP-1RA), recently demonstrated that it was able to not only reduce HbA1c levels in type 2 diabetes (T2D) patients, but also confer weight loss when compared to insulin glargine in the SURPASS-4 trial. Tirzepatide has the potential to achieve […]

Moderna has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older. Stéphane Bancel, Chief Executive Officer of Moderna, said: “We look forward to working with the FDA […]

Moderna has announced that its Phase II/III study of its Covid-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of Covid-19 were observed in participants who had received two doses of the Moderna Covid-19 vaccine. In addition, a vaccine efficacy […]

A clinical trial has begun using a human protein called Annexin A5, which is being studied as a potential therapy for Covid-19 patients with sepsis. Annexin A5 is a protein produced inside the human body with unique anti-coagulation (preventing blood clots) and anti-inflammatory properties that could help in the fight against sepsis. Sepsis is a […]

4D pharma has released additional positive data from its completed Phase II trial of LBP Blautix in subjects with irritable bowel syndrome with constipation (IBS-C) or with diarrhoea (IBS-D). The data has been presented in a poster session at Digestive Disease Week (DDW), on May 22, 2021, by Professor Eamonn Quigley, Head of Gastroenterology and […]

Medicago and GlaxoSmithKline (GSK) have reported positive interim Phase II clinical trial safety and immunogenicity data for Medicago’s plant-derived Covid-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant. These results are part of the ongoing Phase II/III study and reiterate the promising profile observed during Phase I testing. Immunogenicity, as measured […]

Exscientia has announced a Phase I clinical study of DSP-0038 in the US for the treatment of Alzheimer’s disease psychosis. DSP-0038 is the third molecule created using Exscientia’s Artificial Intelligence (AI) technologies to enter clinical trials. The two earlier compounds are DSP-1181, announced in 2020 together with Sumitomo Dainippon Pharma to treat obsessive-compulsive disorder, and […]

Octopus, a world-first mega-trial for progressive multiple sclerosis (MS), will launch in the UK later in 2021, according to the MS Society. It is a clinical trial that is said will transform the way treatments for progressive MS are tested and could deliver new options up to three times faster. Dr Emma Gray, Assistant Director […]

The surge in new variants for Covid-19 and an increase in subsequent cases is continuing to have an impact on clinical trials, while still allowing them to resume. The total number of disrupted trials has levelled off, but the number of clinical trials that have resumed continues to rise, although somewhat slower than the initial […]