April 6, 2020 / Clinical Trials

Audentes Therapeutics Shares Community Update on Duchenne Program & COVID-19

Audentes Therapeutics has shared an update with the community regarding their Duchenne program and COVID-19.

Read the Update from Audentes

Dear Duchenne Patient Leaders,

On behalf of the team at Audentes, we hope that you are staying healthy during this difficult time.

We would like to share with you an update on the status of our programs given the COVID-19 pandemic. In addition to our Duchenne program, I have included an update about our ongoing investigational gene therapy clinical trial for X-linked Myotubular Myopathy since we have received some questions about that program.

We are currently experiencing an unprecedented situation in which the COVID-19 outbreak is affecting families, businesses, communities, and our way of life. During this time we are all facing new challenges and dynamic circumstances, but we remain committed to caring deeply for our employees and the patients we serve.

The US Centers for Disease Control and Prevention (CDC) guidelines consider individuals with certain serious chronic medical conditions an especially at-risk population for more severe cases of COVID-19. During this time, it is critical that we do everything we can to maintain the safety of the patients and families enrolled in our clinical trials and particularly to minimize risk of exposure to COVID-19 for participants who would have been traveling to and from investigational sites.

With this in mind, and in an effort to ensure hospital resources are fully focused on patients with COVID-19, we have made the decision to temporarily delay non-critical clinical follow up visits (and potentially initial dosing) for X-linked Myotubular Myopathy (XLMTM) participants enrolled in the dose-escalation and pivotal expansion cohorts of the ASPIRO clinical trial. We are working with the clinical trial sites to ensure that we can continue to monitor all patients in ASPIRO for safety purposes, by utilizing outpatient nursing. For families enrolled in the ASPIRO clinical trial, participants should continue to speak directly with their clinical trial sites for local guidance especially for information regarding when we are able to resume visits.

For our program in Duchenne muscular dystrophy, we continue to do everything we can to progress our pre-clinical work during this time.

Audentes will continue to monitor the situation very closely as it evolves and will provide updates as soon as we are able. We are working in accordance with guidance issued by global regulatory bodies and evaluating all options that will allow us to continue to advance our programs as soon as it is safely possible for patients. We remain committed to advancing our mission to develop genetic medicines for patients around the world.

As always, please do not hesitate to contact me directly if you have any questions.

All the best,

Chelsea Karbocus
Director, Patient Advocacy and Engagement
Audentes Therapeutics, an Astellas company

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