Clinical trial

Researchers have found that a topical gene therapy gel helps heal wounds in patients with life-threatening blistering skin disease epidermolysis bullosa (EB).  People with dystrophic epidermolysis bullosa often suffer from large open wounds that last for years or decades. It’s an intensely painful condition, and medical treatment for it has been limited largely to palliative […]

Cancer Research UK, The University of Manchester and Roche have opened a multi-drug, precision medicine trial for people with rare cancers.  The trial is set up to recruit both paediatric and adult patients with any rare cancer type and is one of very few precision medicine platform trials in the world targeting these populations.  The […]

New data have shown that GSK’s Shingrix provides at least 10 years of protection against shingles in adults aged 50 years and over. In the primary endpoint, the interim data demonstrated overall efficacy of greater than 80% over the follow-up period of approximately six to 10 years after initial vaccination. The interim analysis data from […]

Enanta Pharmaceuticals, a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, has dosed the first subject in its Phase I clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV).  Context   RSV is the most common cause of bronchiolitis […]

A new Alzheimer’s disease (AD) treatment has been shown to reduce clinical decline in mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology in the brain.  Eisai and Biogen’s anti-amyloid beta (Aβ) protofibril antibody lecanemab met the primary endpoint and all key secondary endpoints in the global Phase […]

A proof of concept (POC) study has shown the clinical benefit of zapnometinib in patients with severe Covid-19 and supports further evaluation in severe viral diseases. Atriva Therapeutics and investigators will continue to evaluate the RESPIRE data and will provide an update on the full dataset in due course. The POC / Phase IIa RESPIRE study […]

A ground breaking ‘immunoablative’ neoadjuvant immunotherapy clinical trial at Memorial Sloan Kettering Cancer Center (MSK) has reported a 100% complete response rate in MMRd locally advanced rectal cancer. Breakthrough findings were presented at the 2022 ASCO Annual Meeting and published in The New England Journal of Medicine by researchers at Memorial Sloan Kettering Cancer Center […]

Researchers from the University of Oxford have today reported new findings from a Phase I clinical trial studying the immune response and safety of their newly-developed single shot rabies vaccine, ChAdOx2 RabG. The RAB001 trial was conducted at the University and is the first time the novel rabies vaccine has been used in human volunteers. […]

uMotif today announced a new investment of $25.5 million from a fund managed by Athyrium Capital Management, LP, the New York-based investment firm. The new funding will support continued scale up of uMotif’s unique patient-first software platform for clinical research.  The company’s software is designed to provide pharmaceutical, biotech, medtech and Contract Research Organisation (CRO) […]

Boehringer Ingelheim’s investigational therapy for idiopathic pulmonary fibrosis (IPF) has shown positive data in a Phase II clinical trial, the company has announced.   The company is investigating its oral phosphodiesterase 4B (PDE4B) inhibitor (BI 1015550) as a potential treatment for people with IPF.   In a Phase II study of 147 patients, those receiving BI 1015550 […]

A vaccine for a range of mosquito-borne viruses has received positive results from a Phase I clinical trial.  Scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) have developed a vaccine for eastern equine encephalitis virus (EEEV), western equine encephalitis virus (WEEV), and Venezuelan equine encephalitis virus (VEEV).  EEV, […]

Drug development consultancy Boyds has bolstered its clinical trials expertise with the appointment of Caroline Corbett as Director of Clinical Operations.   As Director of Clinical Operations at Boyds, Corbett will support Dr Karen O’Hanlon, Vice President of Clinical Operations, with the ongoing growth and development of the clinical operations team and service offering. Corbett […]

News round-up by DDW’s Reece Armstrong for 18-22 April    Covid-19, the link between ageing and genetic mutations, alongside funding opportunities for drug developers are some of the themes of this week’s news round-up.   1: Researchers shed light on ageing in new study   Animals with a large difference in lifespan and size end their natural lives […]

Rani Therapeutics, a clinical stage biotherapeutics company focused on the oral delivery of biologics, has initiated a Phase I study of RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34) for the treatment of osteoporosis, delivered via capsule.  The first subject has been administered RT-102 in the single-centre open label, Phase I study, […]

The MHRA has authorised Merck and Ridgeback Biotherapeutics’ molnupiravir pill for the treatment of at-risk Covid-19 patients, following positive clinical trial results. Molnupiravir is the first oral antiviral medicine authorised for the treatment of mild-to-moderate Covid-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.   In the […]

Moderna has announced positive interim data from its Phase II/III study (KidCOVE) of mRNA-1273, the company’s vaccine candidate against Covid-19, in children six to 12 years of age.   This interim analysis showed a robust neutralising antibody response after two doses of mRNA-1273 at the 50µg dose level with a favourable safety profile. Moderna plans to submit this data […]