Enhancing ALS Care with Clene's Expanded Access Program

We are excited to share that Clene’s Expanded Access Program (EAP) under ACT for ALS is anticipated to begin enrolling patients in June 2024. 

There are three key highlights in this announcement:

• Accessibility: People living with ALS across the United States can benefit from the program, regardless of location. Individuals can access the study through Synapticure’s virtual teleneurology platform, eliminating obstacles such as long travel times or mobility complications due to disease progression, and allowing enrollment for those who don’t live in an area with a local research site.
• Increased Enrollment: Through a collaboration with the National Institutes of Health (NIH), Clene has expanded the EAP program to accommodate 60-80% more patients. This expansion aims to meet the rising demand for the drug CNM-Au8 and provide more access to those with already limited treatment options.‍
• Enhanced Support and Data Collection: Synapticure has implemented FDA-grade data collection, quality tracking, and comprehensive research services across all 50 states. This initiative includes 24/7 care and wrap-around support, ensuring that patients receive the attention they deserve. This robust data collection will facilitate population-level insights, supporting future EAPs, research studies, and clinical trials.

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Why is Synapticure included in this program?

This program aligns with Synapticure’s core mission of democratizing access to care while reducing barriers and costs. Traditionally, enrollment in Expanded Access Programs (EAPs) has been limited to centers running Phase 2 and 3 trials, meaning that individuals who are unable to visit these specific clinics, whether due to distance or other constraints, are often excluded from participating. A burdensome reality for many – we've heard accounts of patients traveling over 500 miles just to access EAPs, a journey that's challenging even for those with sufficient resources and insurance.

Our goal is to allow every eligible patient to enroll in EAP programs and collect high-quality research enabled by telehealth, thereby reaching those who may otherwise be left out while keeping them in the comfort of their homes. By operating across all 50 states, we simplify the complexities of managing Institutional Review Boards (IRBs), clinical oversight, patient enrollment, and data collection. Our focus has been standardizing the collection of in-home clinical outcomes, blood draws, and medication distribution, ensuring alignment with processes conducted at in-person sites. This validation process is a crucial aspect of our program.

The success of this program will provide valuable tools for researchers and future therapies, benefiting thousands of people living with ALS and families through centralized research and care. We are dedicated to ensuring its success and extending access to high-quality research.

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Where do we fit with existing clinics?

While brick-and-mortar ALS centers and multidisciplinary clinics remain indispensable, Synapticure fills a role that complements these institutions, even those with telehealth capabilities, by providing access to specialists within days and wrap-around care services with 24/7 support. We recognize the importance of these centers in clinical care, research, and the diagnostic journey, and we strive to facilitate access for eligible patients whenever possible. Synapticure is focused on leveraging scale and volume to provide harmonized support and development, particularly for patients who may not have access to Centers of Excellence or are ineligible for current clinical trials.

We are grateful for the opportunity to contribute to the advancement of ALS treatments and investigational therapy access programs, and we are committed to supporting those who may otherwise be overlooked or underserved. 

More information about the study, including participating sites, can be found on the study website at https://clenecompassionateuse.com/.

To speak with the Synapticure team about study enrollment, you can call us at 708-630-1534 or email us at research-studies@synapticure.com.