We recently sat down with Kasey Woleben, Co-founder, and Sophia Zilber, Board Member and Patient Registry Director of Cure Mito Foundation, to talk about their work and the important role patients play in the research and development of potential new therapies for mitochondrial diseases, particularly via patient registries. A patient registry is a collection of information about patients who have a specific disease or condition. Low prevalence and lack of disease knowledge can slow the development of new treatments for rare diseases, such as mitochondrial diseases, and patient registries can help overcome many of these hurdles by connecting patient communities to researchers to identify potential patients for clinical studies, and to improve overall scientific understanding of a disease.

 

  1. How did you first become involved with the mitochondrial disease community and the Cure Mito Foundation?

 Sophia: I became involved with the mitochondrial disease community after my new-born daughter, Miriam, tragically died from Leigh syndrome in 2017. I work in statistical programming and analysis of clinical trials data in the pharmaceutical industry and knew that I was in a position to make a difference in a unique way. I wanted to dedicate my expertise and time to this cause. Kasey Woleben, a Co-founder of the then named Cure SURF1 Foundation and I initially connected through social media. I was impressed by Kasey’s extreme dedication and courage to forge her own path. She shared with me her desire to expand the foundation and to rename it Cure Mito Foundation. I fully supported her vision and when she asked me to join her efforts, I was thrilled to accept.

 

  1. How did you first become involved with the mitochondrial disease community and what led you to establish the Cure Mito Foundation?

 Kasey: In 2014 my 2-and-a-half-year-old son was diagnosed with Leigh syndrome after a seemingly normal childhood. After the shock of the diagnosis and being told by doctors there was no treatment or cure, in 2018 we decided to form Cure SURF1 Foundation focusing on Will’s specific mutation. We started the organisation with other SURF1 Leigh syndrome parents and raised over $1 million for gene therapy research. Last summer we decided we wanted to include all 100+ mutations that can cause Leigh syndrome and so renamed the organisation Cure Mito Foundation. We are 100% volunteers and fund high-risk/high-reward research because with Leigh syndrome everything is a race against time.

 

  1. Tell us about Cure Mito and the work it is doing to support individuals and families living with mitochondrial disease.

Kasey: As parents who lead the organisation, we believe it is important to provide education to newly diagnosed families, to give them hope and to let them know they are not alone. Our activities are broad but include hosting webinars on patient registries, research, and caregiver needs.

 

  1. Sophia, as Patient Registry Director, tell us about your role at Cure Mito and how it impacts the organisation’s research and network with the wider mito community.

Sophia: As Patient Registry Director, I’m responsible for leading our work on the Leigh syndrome Global Patient Registry. This includes creating or updating a survey, analysing data, preparing results, planning publications and much more. Our work is very collaborative and we have an excellent network of scientific and medical advisors who help us with data or medical expertise.

 

One of my priorities is ensuring that all our registry activities are transparent, and we have a two-way communication with patients who sign up for the registry. We consistently share results and information through our website, social media channels and newsletter and always emphasise that those who have any questions or concerns are always encouraged to reach out to us – it’s an open-door policy and all inquiries are welcome and taken seriously.

We network with the wider mito and rare disease communities a lot. One of the ways we do this is through a collaboration on data sharing with the Critical Path Institute (C-Path). Their Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) is funded by the FDA and can be used to integrate various datasets so that more can be learned from the combined data. Recently, we have introduced MitoAction and C-Path, which has resulted in a new collaboration where MitoAction’s mobile app data will be integrated into RDCA-DAP. We look forward to seeing what insights and findings will come out of this data.

Our other exciting collaboration is with Sumptuous Data Sciences on alignment and interoperability of our patient registry data with Regulatory Submission Standards. This will be a very important and interesting learning experience not only for our registry, but for other mito and rare disease patient registries, and we will be sharing it widely.

We’re also a part of patient group alliances such as EveryLife Foundation Community Congress, Indo US Organization for Rare Diseases, UPenn Orphan Disease Center Jumpstart Program and others. These connections are giving us more opportunities to break silos and build a wider network.

Prior to my daughter’s passing, I had never been involved with rare disease or any other disease community and didn’t know that patient advocacy groups run registries. One thing I have observed is that while there are many efforts to collect data, there’s not as much awareness about other steps needed to obtain high quality data, such as designing the most optimal survey, checking data for data issues, performing data analysis and more. I try to share these best practices and empower patients to ask questions about how their data is handled and used. I do this through talks at conferences, podcasts, and frequently in smaller settings – mito and rare disease groups frequently reach out for advice on setting up their registries, and I’m always happy to help. I believe all these efforts will make a difference over time.

 

  1. How is Cure Mito helping to advance research into mitochondrial diseases and why is it so important for organisations like Cure Mito to support and fund this research?

Kasey: When your child is diagnosed with a mitochondrial disease such as Leigh syndrome, doctors really give you no hope, we want to change that. We are focused on outside-of-the-box therapies and research for Leigh syndrome. We believe that partnering with motivated researchers who feel our sense of urgency is important. We are parents on a mission to save our children.

 

  1. Why is it so important for organisations like Cure Mito to support and fund mitochondrial research?

Sophia: With any rare disease, funding is an issue, and patient organisations play a critical role in raising the funds and advancing research and treatments. Additionally, as an organisation focused on patients and led by parents, we make decisions that put patients at the centre. It is good to see that now many emerging researchers are entering the mitochondrial disease space, who bring new and fresh perspectives, collaborative mindsets, and are ready to think outside the box. It is important to support them.

 

  1. What role do you see Cure Mito playing in the fight to improve the quality of life for people with mitochondrial diseases?

 Sophia: Patients are at the heart of all that Cure Mito does. It is a part of our mission and is embedded in our logo with two mitochondria shaped as a heart. Our work to raise awareness and support research is one of the very important ways to improve patients’ quality of life over time. Our work on the patient registry exists so that patients can be counted and be aware of clinical trials or research opportunities that may be relevant. Additionally, our website has many support resources for patient families. We have a newly diagnosed guide that we recently posted, which includes information on overall well-being of a person such as self-care and relationships with others. We also have a birthday club, links to other support organisations, a lot of educational materials, links to books about finding hope and courage in the face of difficult circumstances and even a very cute page for kids with some kids’ books. We are always working on new information and those who would like to make suggestions or join our efforts are welcome!

 

Kasey: Since Cure Mito is led by parents of affected children, we live with this disease 24/7. We are the experts. We believe that transparency is key to helping improve the quality of life for our children.  Our Global Leigh Syndrome Patient Registry is helping researchers to better understand the disease which we hope will ultimately help find a treatment or cure for this disease.

 

  1. Have you seen a change in awareness of mitochondrial disease since you first became involved in the community?

 

Kasey: Yes, there have been tremendous changes in awareness of mito diseases. There are more grassroots efforts led by parents of affected children that focus on particular mitochondrial diseases which are needed considering the large number of patients.

Sophia: I’m relatively new to the mitochondrial disease community and have not been involved long enough to observe a difference. Definitely a lot has already been done by those who have been a part of this community for many years. But a lot still remains to be done. I believe that in order to get to treatments as quickly as possible, our community should welcome new leaders, be open to new ideas, new perspectives and ways of thinking. There’s so much work to do and there should be a place for everyone at the table.

 

  1. What are your hopes for the future for people living with mitochondrial diseases?

Sophia: I think everyone wants to see treatments and cures as soon as possible. But until we get there my hopes are that patients feel less alone and that each patient is seen as a person first. I frequently think about a meeting we had with our medical team at Boston Children’s Hospital when my daughter’s MRI results became available. At that time, we didn’t know yet that anything was seriously wrong. I remember that our daughter’s neurologist told us that the MRI revealed some findings and then asked if we would like him to display the images on the screen or go over the results without showing the images. We agreed to see the images, but his sensitivity has stayed with us forever – he knew that this meeting would split our lives into a before and after and wanted to make the process a little less painful. I wish for all patients to be treated with kindness and compassion, to feel seen, heard, and understood, to be able to advocate for themselves and their families and to have resources and support they need.

Kasey: Our hope is that the mito community knows how important their role in research is. We absolutely believe that the more we understand about mito, the closer we get to treatment. That means understanding drug development and participating in clinical trials, registries, and biorepositories. Every one of us can make a difference – it truly takes a village to want to change the outcome of mitochondrial disease.

  1. What advice would you give to patients and families affected by mitochondrial disease?

Kasey: Never lose hope. And do not focus on the negatives of this disease. Live each day one at a time and enjoy every moment. And know that you have the power to change the outcome of this disease by joining efforts in the mitochondrial community – your voice is needed and the only way we can change this disease is by understanding the natural history and disease progression and by spreading awareness throughout medical, research, family, friend communities. Please join our virtual conference on 20 September 2022, during World Mitochondrial Awareness Week – you will hear updates from researchers, industry, and others and ways that you can be involved!