Pharmaceutical Market Europe • Spetember 2022 • 8-9
NEWS
A new drug candidate may be effective against more than 200 antibiotic-resistant bacteria, according to research published in the American Chemical Society Central Science journal.
The drug, fabimycin, has the potential to infiltrate the defences of Gram-negative bacteria and treat infections, while leaving other helpful microbes intact.
The research team noted that there hasn’t been a novel class of antibiotics approved by the US Food and Drug Administration to treat Gram-negative pathogens contained within the group of high-priority antibiotic-resistant bacteria for over 50 years.
Gram-negative bacteria are a class of microbes that infect millions of people worldwide, according to the US Centers for Disease Control and Prevention, causing pneumonia, urinary tract infections and bloodstream infections.
The team, led by Paul Hergenrother, professor of chemistry at the University of Illinois, began their research with an antibiotic that was active against Gram-positive bacteria and made a series of structural modifications that they believed would allow it to act against Gram-negative strains.
One of the modified compounds – fabimycin – proved to be effective against more than 200 drug-resistant clinical isolates of Escherichia coli (E. coli), Klebsiella pneumoniae and Acinetobacter baumannii, while remaining ‘relatively inactive’ toward certain Gram-positive pathogens and some typically harmless bacteria that live in or on the human body.
Novartis’ radioligand therapy (RLT) Pluvicto has received its first approval in Europe as a treatment for advanced prostate cancer from the Medicines and Healthcare Products Regulatory Agency (MHRA).
The decision applies to England, Scotland and Wales, and makes Pluvicto the company’s second radioligand therapy to be given a green light, after Lutathera, which was approved for the treatment of neuroendocrine tumours.
The MHRA based its decision for Pluvicto’s marketing authorisation on the alternate primary endpoint results from the phase 3 VISION trial – a randomised, open-label, international, multi-centre study where patients with progressive PSMA positive mCRPC were treated with at least one androgen-receptor-pathway inhibitor and one or two taxane regimens.
The study showed that Pluvicto added onto standard-of-care reduced the risk of death by 38% compared to standard care alone in men with PSMA+ mCRPC who had progressed after three or more prior anti-androgen and chemotherapy regimens.
The authorisation is for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
The US offers Pluvicto as a treatment, following its approval from the US Food and Drug Administration in March this year.
GSK’s New Drug Application for patients with bone cancer (myelofibrosis) with anaemia has been accepted by the US Food and Drug Administration (FDA).
Myelofibrosis is a type of bone marrow cancer that disrupts the normal production of blood cells and causes extensive bone marrow scarring, leading to severe anaemia.
The FDA is due to make a decision on momelotinib – which GSK maintains may address a ‘significant unmet need’ – by 16 June 2023. If accepted, the commercial launch of momelotinib is anticipated in 2023.
The application is based on results from key phase 3 trials, including the pivotal MOMENTUM trial, for patients with myelofibrosis who had been previously treated with an FDA-approved Janus kinase (JAK) inhibitor.
Momelotinib is a JAK1/2 inhibitor that treats symptoms of the cancer while also targeting other pathways called ACVR1 and IRAK1 that are thought to protect against anaemia.
The study met all its primary and key secondary endpoints, showing that momelotinib offered a significant and clinically meaningful benefit for symptoms, splenic response and anaemia.
The treatment was most recently developed by Sierra Oncology – a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare cancers – that was acquired by GSK in July 2022 in a deal worth £1.5bn.
Parkinson’s UK and the Parkinson’s Foundation have announced an international strategic partnership to ‘speed up the search for new treatments’ for Parkinson’s disease.
The partnership includes a $3m investment from the Parkinson’s Foundation into the Parkinson’s Virtual Biotech, the drug development arm of Parkinson’s UK.
The money will be paid over a three-year period and will complement the ongoing investment from Parkinson’s UK – currently standing at over $19m since it started in 2017 – to accelerate research into scientific breakthroughs.
Led by pharma and biotech experts, the Virtual Biotech team reviews and curates the most promising research that would otherwise struggle to find private sector investors from the thousands of studies underway at any given time. The Parkinson’s Virtual Biotech then invests in these directly, providing ongoing oversight and stewardship, and identifying the right global partners to work with.
By operating like a biotech, but without the additional costs of full-time staff and buildings, the Parkinson’s Virtual Biotech is a ‘uniquely innovative approach’ to drug development within the charity sector, Parkinson’s Foundation stated.
Nine projects are currently being fast-tracked, including the potential of cannabidiol to treat psychosis in Parkinson’s disease, to assess whether a common anti-sickness drug could manage hallucinations, and if it is possible to develop therapies that restore mitochondrial function to slow or stop the condition.
Roche has announced the launch of the Digital LightCycler System, its first digital polymerase chain reaction (PCR) system, to help clinical researchers ‘better understand’ the nature of a patient’s cancer, genetic disease or infection.
The new system has the potential to find and quantify ultra-rare, hard-to-detect mutations, by allowing researchers to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions. The system can then perform PCR and produce ‘highly sophisticated’ data analysis on the results.
In areas such as oncology and infectious disease, the system provides ‘new opportunities’ for researchers beyond what traditional PCR technology can achieve, the company said, leading to early diagnosis and treatment strategies.
It is hoped that the system will provide laboratories performing highly sensitive and precise DNA and RNA analysis with flexibility through three unique reaction plates. This will include allowing customisation of the sample volumes used, the number of times a sample is divided and how many different tests can be run on a single sample – known as multiplexing.
The system will be available in 15 countries worldwide in 2022 with plans to launch into more countries in the near future, the company said. The system will be CE-marked and has a US Food and Drug Administration 510(k) exempt status.
Novo Nordisk has announced its headline results from a phase 2 clinical trial with CagriSema – a once-weekly subcutaneous combination of semaglutide and a novel amylin analogue, cagrilintide – in people with type 2 diabetes.
The trial investigated the efficacy and safety of a fixed dose combination of CagriSema compared to the individual components semaglutide and cagrilintide, all administered once-weekly, in 92 people with type 2 diabetes who are overweight.
People treated with CagriSema achieved a numerically higher HbA1c reduction of 2.18%-points compared to a reduction of 1.79%-points for people treated with semaglutide and 0.93%-points with cagrilintide alone, after 32 weeks of treatment.
In addition, those treated with CagriSema lost more weight (15.6%) compared to those treated with semaglutide (5.1%) and those treated with cagrilintide alone (8.1%). CagriSema appeared to have a safe and well-tolerated profile in the trial.
More than 4.9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK. There is currently no cure for type 2 diabetes, with current treatment options focused on disease management, including diet and exercise, diabetes medications or insulin therapy.
Novo Nordisk has outlined its plans to initiate a phase 3 development programme for CagriSema for people with type 2 diabetes in 2023, which is expected to begin later this year.