Patient board to shape clinical trials for pioneering new therapy
Company 4D pharma is working with Parkinson’s UK to set up a Patient Advisory Board to help guide their upcoming clinical trials of a promising new therapy that targets the microbiome — the collection of bacteria that naturally live in the human gut — and the gut-brain axis.
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4D pharma is a UK-based pharmaceutical company headquartered in Leeds and is focused on harnessing Live Biotherapeutics consisting of specific strains of bacteria for the potential treatment of a range of conditions from cancer to asthma to neurodegenerative conditions.
Currently, 4D pharma is planning a clinical trial to test a new treatment in people with Parkinson’s. This initial study will investigate the safety of this novel therapy and look for signs of therapeutic activity on certain aspects of the condition in people recently diagnosed with Parkinson’s.
An increasing body of evidence indicates a key role for the microbiome and the so-called ‘gut-brain axis’ in the onset, progression, and potentially treatment of Parkinson’s. Ultimately, by using a specific strain of bacteria which has shown interesting activity on features of Parkinson’s in earlier research, it is hoped that this new approach may treat the underlying causes of Parkinson’s and therefore slow down or even prevent progression of the condition.
“4D pharma approached us as they were keen to work with people affected by Parkinson’s to help design the study from the outset,” explains Natasha Ratcliffe, Research Involvement Manager at Parkinson’s UK.
“We worked together to plan the best way to get input from people with the condition, and decided to create a Patient Advisory Board. This will enable people affected by Parkinson’s to have direct input into the development of this novel treatment. This is so important to ensure that new treatments really address the concerns and needs of those affected by this condition.”
The Patient Advisory Board will provide the patient perspective on all aspects of clinical development to help ensure that the study is feasible and practical for future participants and the outcomes are meaningful to people affected by the condition.
Helen, a former GP and person living with Parkinson’s, explains why she joined the board:
“When I was first diagnosed with Parkinson’s 4 years ago my initial reaction was relief as I could start the appropriate medication. The drugs helped, but not completely and I felt quite helpless and adrift.
“Becoming involved in the Advisory Board has helped me regain some focus and control over my illness.
“I hope that by sharing my experiences, researchers can design trials that are more relevant and practical for people with Parkinson’s, with better knowledge of our limitations. For example being asked to lie for an hour in an MRI scanner is torture if you have tremor!
“The science is fascinating and helps me keep my little grey cells working as an added benefit. It’s a privilege to be able to work with dedicated researchers to fight this condition and see how much our understanding of Parkinson’s is growing.”
Alex Stevenson, Chief Scientific Officer of 4D pharma adds, “The contributions of our Patient Advisory Board, with the support of Parkinson’s UK, will be vital to 4D pharma’s efforts not only to develop novel therapeutics for this devastating condition, but also promote a dialogue and partnership with the Parkinson’s patient community.”
“It is important that therapeutics in development address the issues of patients. By working with Parkinson’s UK and our Patient Advisory Board, 4D pharma is better able to engage Parkinson’s patients with our clinical programs as we work to bring the first live biotherapeutic for the treatment of this condition into the clinic.”
4D pharma expects to be ready to commence a clinical trial of their ground-breaking therapy in early 2022.
Find out how we can support researchers to involve people affected by Parkinson’s in there work — parkinsons.org.uk/research/patient-and-public-involvement-research
If you are someone with Parkinson’s or a partner, family member or carer who wants to help shape research, click on the banner below to find out more.
