Feature

Betsy Goodfellow from Pharmafocus looks back at 2023 and reviews some of the biggest pharma news of the year

In January, researchers at King’s College London’s Institute of Psychiatry, Psychology and Neuroscience (IoPPN) developed a blood test that appeared to predict Alzheimer’s disease (AD) three and a half years before clinical diagnosis. This research was published in Brain and demonstrated that components in the blood can modulate neurogenesis (the formulation of new brain cells) in the hippocampus. AD has been shown to impact neurogenesis in the hippocampus in early stages of the disease, however previous studies have only assessed this in the later stages of disease progression.

Similarly, in March, Roche and Eli Lilly announced a collaboration to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), which can test for AD before symptoms arise.

Both of these new tests are a marked improvement on current standard of care, which consists of expensive and time-consuming PET brain scans, spinal fluid analysis and cognitive testing, and both blood tests offer better alternatives.

Matt Sause, chief executive officer of Roche Diagnostics, said: “We are excited to be collaborating with Lilly on such an important area of unmet medical need. Today, over 55 million people are living with dementia and this is projected to increase to nearly 140 million by 2050. Collaboration is essential to ensure these people receive atimely and accurate diagnosis. The Elecsys Amyloid Plasma Panel has the potential to streamline a person’s journey to diagnosis and, therefore, access to future treatment options.” In terms of AD treatments, Eisai and Biogen have shared various updates with new data for their AD therapy, Leqembi (lecanemab-rimb). In October, at the 16th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston in the US, the companies shared information on the drug’s subcutaneous (SC) formulation, including safety and impact on brain amyloid, such as evidence of weekly SC administration showing a 14% greater amyloid plaque removal compared to biweekly IV administration.

In a world first, in May 2023 the US Food and Drug Administration (FDA) approved the first vaccine against respiratory syncytial virus (RSV) for use in patients over the age of 60 in the US. The vaccine, Arexvy, was developed by GSK Biologicals and received approval based on results from the AReSVi-006 phase 3 randomised, placebo-controlled clinical trial.

Since Arexvy’s approval, various other RSV vaccines have been approved for other patient populations, including AstraZeneca’s Beyfortus, which was approved in July for the prevention of RSV lower respiratory tract disease (LRTD) in neonates and infants born during or entering their first RSV season and in children up to 24 months.

As well as RSV, this year has seen developments in other vaccine areas, with the World Health Organization (WHO) recommending a new vaccine, R21/Matrix-M, in October for the prevention of malaria in children. This is only the second malaria vaccine to be recommended by WHO, following RTS,S/AS01, which was recommended in 2021. Both vaccines demonstrated safety and efficacy in preventing malaria and are expected to have a marked impact on public health.

As well as the various new vaccines gaining approvals, a new research centre was opened in August as part of the UK Health and Security Agency’s (UKHSA) Porton Down campus in Wiltshire in the UK. This facility is intended to prepare for ‘disease X’ – the next possible pandemic pathogen. The Vaccine Development and Evaluation Centre was established as a result of the UK’s COVID-19 inquiry, which stated that the government was ill-prepared for the pandemic, with too much focus on flu outbreaks rather than other viruses.

UKHSA’s chief scientific officer, Professor Isabel Oliver, commented: “We know that through scientific advancement, we could detect and control these spreads before they have the impact that COVID-19 had on our lives. It’s not easy, but we know that if we strengthen surveillance and if we accelerate the development of diagnostics, vaccines and therapeutics, we could do so much better. We need to be prepared for all threats, including those that have not been detected yet.”

This year has also seen advances in the fight against antimicrobial resistance (AMR). In May, scientists at McMaster University and the Massachusetts Institute of Technology (MIT) in the US announced that, using artificial intelligence (AI), they had discovered a new antibiotic that appears to fight a drug-resistant ‘superbug’ often found circulating among vulnerable hospital patients. The researchers identified the new antibacterial compound, known as abaucin, using an AI platform to predict structural classes of antibacterial molecules.

In the UK, the University of Birmingham’s Bacterial Vaccines Network received £1.4m in government funding to accelerate development of bacterial vaccines against AMR. This follows a £1.4m award from the Global AMR Innovation Fund (GAMRIF) in 2019.

In June, the European Parliament shared its goals to tackle AMR, with Members of the European Parliament (MEPs) voting 525 to two in favour of measures to control the threat, with 33 abstaining. As a result, EU countries will implement ‘National Action Plans’ to tackle AMR that will need to be updated at least every two years, making this a priority for their health services. Other measures include addressing antimicrobial consumption, supporting research and working to prevent medicine shortages.

Following the COVID-19 pandemic, a number of companies continue to work toward improving treatment and prevention of the disease.

In May, the FDA approved the first oral antiviral to treat adult patients with COVID-19; the drug, Paxlovid, can be used to treat adult patients with mild-to-moderate COVID-19 if they are at risk of developing severe COVID-19. Previously this drug has been authorised under the Emergency Use Authorisation (EUA) and distributed by the US Department of Health and Human Services.

The National Institutes of Health (NIH) has launched its RECOVER initiative, a series of trials intended to lead to the first official treatment for long COVID. It has taken some time for researchers to understand long COVID and before the trials could be initiated, treatments had to be formulated and various governing bodies had to approve the study design prior to it commencing.

In October, Moderna shared positive interim results from the phase 1/2 trial of mRNA-1083, its investigational combination vaccine against influenza and COVID-19. In the clinical trial, the vaccine was compared to the Fluarix vaccine in patients aged 50-64 and Fluzone HD in patients aged 65-79, with comparison in both age groups to the Spikevax booster. The vaccine candidate demonstrated hemagglutination inhibition antibody titres similar to or greater than the licensed quadrivalent influenza vaccines, while also achieving SARS-CoV-2 neutralising antibody titres similar to the Spikevax booster.

After such an eventful year for pharma, with advances including new AD blood tests and treatments, the world’s first RSV vaccine and the European Parliament continuing to fight against AMR, as well as further COVID-19 treatments and vaccines, it is exciting to look ahead to next year, with expectations of innovative new research and the promise of all that AI can bring to the pharma industry.