July/August 2023 • PharmaTimes Magazine • 9
// CONDITIONS //
Valneva reveals chikungunya vaccine data
Valneva – a company focused on developing vaccines for global conditions – has announced that critical phase 3 data in relation to its single-shot chikungunya vaccine, VLA1553, has been published in The Lancet.
The candidate is a single-shot live-attenuated vaccine and has been subjected to a double-blind, multi-location, placebo-controlled, randomised phase 3 trial.
Consequently, the results demonstrated that VLA1553 had a very high seroresponse rate of 98.9% among participants, 28 days after receiving a single administration.
The immunogenicity profile, therefore, was similar across younger and older adult populations, while 96% of participants maintained seroresponse six months after their vaccination.
Furthermore, VLA1553 was generally safe and equally well tolerated in both younger and older adults.
Juan Carlos Jaramillo, chief medical officer of Valneva, was very optimistic about the vaccine candidate and the impact it could make: “This publication in The Lancet underlines the strength of VLA1553’s scientific approach and is consistent with the quality of our pivotal phase 3 study.”
He added: “We are pleased that more detailed results on our single-shot chikungunya vaccine candidate are now available to the scientific and broader public health communities.”
VLA1553 remains the only global chikungunya vaccine candidate undergoing regulatory review processes. Meanwhile, a biologic license application is currently under ‘priority review’ by the US Food and Drug Administration.
If approval is granted, VLA1553 could then become the very first licensed and available chikungunya vaccine.
Cardiff University begins study of schizophrenia therapy
A new schizophrenia drug being developed by Cardiff University’s Medicines Discovery Institute (MDI) has completed the first phase of a phase 1 clinical trial.
The treatment candidate, known as MDI-26478, is a positive allosteric modulator of the AMPA receptor. Indeed, this receptor is thought to play a pivotal function in overall brain health.
The Cardiff team expects MDI-26478 to improve wider cognitive performance and is initially concentrating on schizophrenia.
Meanwhile, remaining stages of the clinical trial will run in Merthyr Tydfil, at Simbec-Orion's Medicines and Healthcare products Regulatory Agency-accredited Unit. Neuroimaging studies will take place at Cardiff University Brain Research Imaging Centre and neurophysiological screening will be provided by The Science Behind – a Cardiff-based research service.
Dr Jennifer Swettenham, who has led the clinical trial, was optimistic about the progress of the candidate: “We are delighted that MDI-26478 has completed our initial studies and has been shown to be safe at all doses. We are focused on completing the remainder of the study.”
Professor Simon Ward, director of Cardiff University’s MDI, added: “This is the first step of the journey towards developing this treatment. We hope to have initiated an exciting leap forward in the way we will treat schizophrenia in the future.”
The clinical study has been funded by Wellcome.
HOT & NOT
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy.
The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older. It can also be used to treat adolescents with growth failure due to growth hormone deficiency.
Transgene – a company focusing on cancer immunotherapeutics and BioInvent International AB, which concentrates on the discovery of antibodies, have announced positive phase 1a data related to the oncolytic virus BT-001. The therapy has been developed for treating solid tumours.
Incorporating single agent BT-001 as a treatment among 18 patients has now reached its conclusion, with no safety concerns reported.
Individuals in the patient group had at least one superficial lesion and all were studied in three dose-escalating cohorts.
Rosemont Pharmaceuticals has announced the acquisition of Lucis Pharma. The purchased company is a specialist pharmaceutical business based in the UK.
Consequently, Rosemont will gain access to a considerable pipeline of products, offering therapies across the UK and within overseas markets.
Lucis – which was founded in 2012 – has several products covering a wide variety of conditions, and has built a robust portfolio, particularly serving the patient need for liquid medicines.
The ambitious life sciences programme by the UK government is gaining much-needed momentum. With a wide-ranging series of proposals to boost the clinical trials ecosystem, however, the key to the success of the plans will be an ability to overcome significant commercial challenges.
Recently, the Life Sciences Council, comprising ministers and global life sciences industry leaders, convened to discuss how the UK can realise and sustain the economic potential of the sector. Critically, they also addressed recent declines in clinical trials performance.
Commenting on the latest industrial action by junior doctors, Rory Deighton, from the NHS Confederation reflected:
“The NHS has become used to managing the disruption caused by industrial action so patients should feel assured their local services are doing everything they can, however, each wave of strikes chips away at the NHS’s resilience, impacting on staff, internal relationships and their ability to deliver on government pledges to reduce the elective backlog.”
Vaping among young people is rising and the habit has recently made the headlines for enticing people with colours and flavours without inherent – known and unknown – risks being clearly highlighted.
There has also been a growing environmental problem in terms of the disposal of vape paraphernalia and the lithium batteries therein.