Pharmaceutical Market Europe • July/August 2024 • 8-9
NEWS
Researchers identify new major cause of inflammatory bowel disease
Researchers from the Francis Crick Institute, University College London and Imperial College London have identified a new major cause of inflammatory bowel disease (IBD).
After investigating an area of DNA that does not code for proteins, known as a ‘gene desert’, which has previously been linked to IBD and several autoimmune diseases, researchers discovered a section of DNA known as an ‘enhancer’ that increases the number of proteins they make up.
Only active in macrophages, a form of immune cells found in IBD, the enhancer also boosted a gene known as ETS2 with higher levels that correlated with a higher risk of disease.
The team used genetic editing to show that ETS2 was essential for almost all inflammatory functions in macrophages, particularly those that directly contribute to tissue damage in IBD.
By increasing the amount of ETS2 in resting macrophages, researchers found that they turned into inflammatory cells that closely resembled those from IBD patients.
In addition, researchers revealed that many other genes previously associated with IBD are part of the ETS2 pathway, further highlighting that it is a major driver of IBD.
Moderna shares positive late-stage results for COVID-19/flu vaccine
Moderna has shared positive late-stage results for its investigational combination vaccine against influenza and COVID-19.
The ongoing phase 3 trial has been evaluating the candidate, mRNA-1083, in two age-group cohorts of approximately 4,000 adults each.
One cohort has been comparing mRNA-1083 to Sanofi’s enhanced Fluzone HD flu vaccine co-administered with Moderna’s stand-alone COVID-19 vaccine Spikevax in adults aged 65 years and older, while the other has been comparing the combination vaccine to GSK’s standard dose Fluarix flu vaccine in adults aged 50 to 64 years, also given alongside Spikevax.
The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered comparators, and mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2 in both groups.
Moderna also reported that mRNA-1083 showed an acceptable tolerability and safety profile, with the majority of solicited adverse reactions consistent with the vaccines used in the trial.
The company said it is planning to present the phase 3 data for mRNA-1083 at an upcoming medical conference and will “engage with regulators on next steps”.
Tiziana shares promising results for intranasal foralumab in MS
Tiziana Life Sciences has shared promising six-month results for intranasal foralumab in non-active secondary progressive multiple sclerosis (SPMS).
SPMS is a stage of MS that comes after relapsing-remitting MS for many patients. With this form of the disease, disability steadily worsens and relapses become unlikely.
Tiziana’s foralumab, a fully human anti-CD3 monoclonal antibody, is designed to bind to the T-cell receptor and dampen inflammation by modulating T-cell function, thereby suppressing effector features in multiple immune cell subsets.
The latest results for the therapy showed that 80% of non-active SPMS patients enrolled in an expanded access programme to receive foralumab for at least six months demonstrated qualitative improvements in PET imaging.
Out of the latest cohort of four expanded-access patients, three had findings that suggested a qualitative reduction in the microglial PET signal over the six-month treatment period.
Tiziana recently received an allowance from the US Food and Drug Administration for an additional 20 patients to be enrolled in the intranasal foralumab MS expanded access programme, which it said will allow for further data collection and analysis.
EMA announces launch of two advice pilots for clinical trials
The European Medicines Agency, in collaboration with the Heads of Medicines Agencies and the European Commission, has announced that the Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two advisory pilots to improve clinical trials in the EU.
The pilots are aimed at improving the quality of applications for clinical trials and laying the foundation for the development of safe and effective medicines in Europe.
The first pilot will offer medicinal product developers scientific advice on clinical trials and requirements for marketing authorisation applications and will be assessed by the Scientist Advice Working Party and the Clinical Trials Coordination Group (CTCG).
Covering a variety of areas, including advice on regulatory aspects of low intervention clinical trial status and submission of trials with decentralised elements or complex designs, the second pilot, coordinated by the CTCG, will provide technical and regulatory support on the dossier of clinical trial applications prior to submissions through the Clinical Trials Information System and will provide consolidated views of the member states concerned on pre-submission topics.
WHO reports on development of antibacterial agents worldwide
The World Health Organization (WHO) has published its latest report on antibacterial agents, including antibiotics, which are in clinical and preclinical development worldwide.
The annual report aims to improve the research and development pipeline to address infections caused by drug-resistant bacteria most threatening to health and to tackle the growing threat of antimicrobial resistance.
In May, WHO released the updated 2024 WHO bacterial priority pathogen list (BPPL), to highlight drug-resistant bacteria that are most threatening to human health.
The new report highlighted that only 12 of the 32 antibiotics under development to address BPPL infections can be considered innovative, four of which are active against at least one WHO critical pathogen.
In addition, it revealed gaps across the pipeline, including in products for children, oral formulations more convenient for outpatients and agents to tackle rising drug resistance.
WHO also outlined that while non-traditional biological agents are increasingly being explored in addition to and as alternatives to antibiotics, studying and regulating them requires further efforts to facilitate clinical studies and assessments to determine when and how to use these agents clinically.
J&J agrees $700m settlement with US states to resolve talc claims
Johnson & Johnson (J&J) has reached a $700m settlement with more than 40 US states over their investigation into the marketing of its talcum powder-based products, which have been alleged to cause cancer.
The agreement resolves allegations that the company misled consumers in advertisements related to the safety of the products, including its baby powder.
A tentative deal was originally announced in January and the settlement was led by the attorneys general of Florida, North Carolina and Texas.
J&J has ended global sales of the affected products in favour of cornstarch versions, with the company continuing to maintain that the products are safe.
Under the new consent judgement, J&J will not resume the manufacturing, marketing, promotion, sale and distribution of any baby and body powder products, and cosmetic powder products that contain talcum powder in the US.
The company continues to face tens of thousands of talc lawsuits, as well as a class action accusing it of hiding the products’ dangers from shareholders.
It put forward its latest settlement last month, offering $6.475bn over 25 years to customers with ovarian cancer claims.
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