#United States #Los Angeles #ALS #Spinogenix #SPG302

Spinogenix Introduces Expanded Access Program for SPG302

Overview
On May 5, 2025, Spinogenix, Inc., a forward-thinking clinical-stage biopharmaceutical firm, announced that it has received FDA clearance for an Expanded Access Program (EAP) for its innovative therapy, SPG302. This program aims to provide access to SPG302, the first synaptic regenerative treatment for Amyotrophic Lateral Sclerosis (ALS), to patients who do not meet the eligibility criteria for existing clinical trials.

Significance of SPG302
Developed for treating ALS, SPG302 offers a groundbreaking approach by potentially slowing or even reversing cognitive and motor function declines associated with the disease. This is particularly significant given the urgent need for effective treatments for ALS, a condition that has primarily been viewed as untreatable. Dr. Stella Sarraf, CEO and Founder of Spinogenix, highlighted that this program reflects the company’s commitment to improving the lives of ALS patients and their families.

Expanded Access Program Details
The FDA facilitates EAPs for severely ill patients to access investigational treatments not yet fully approved. Through this initiative, eligible adults with ALS can receive SPG302 while concurrent clinical studies continue to assess its effectiveness and safety. By allowing real-world data collection, the EAP supports the broader clinical development of SPG302, amplifying the understanding of its potential benefits.

Notably, Dan Doctoroff, founder of Target ALS and the first recipient of SPG302 under a different EAP, remarked on the positive experience he had with the drug. He emphasized that the earlier belief that ALS is entirely untreatable is outdated, suggesting a paradigm shift towards recognizing the possibilities SPG302 may provide.

What is SPG302?
SPG302 is a daily oral medication designed to regenerate synapses, the vital connections between neurons that are crucial for cognitive functioning and movement control. By targeting neurosynaptic restoration, SPG302 represents a class of treatment that could fundamentally reshape expectations concerning neurodegenerative diseases. Additionally, SPG302 has received Orphan Drug Designation from the FDA for its potential to treat ALS, with previous phases of clinical trials demonstrating promising outcomes.

Beyond ALS, Spinogenix is also investigating SPG302 for other disorders, including Alzheimer's disease and schizophrenia, underlining the compound's versatility and fundamental innovation in neurotherapeutics.

Moving Forward
The company has launched a Phase 2 ALS trial in Australia, which offers participants a continuation of treatment through an open-label extension. As these trials progress, further information will be publicly accessible on ClinicalTrials.gov to ensure transparency and continuous engagement with the ALS community.

About Spinogenix
Spinogenix is on a transformative mission within the biopharmaceutical landscape, striving to redefine treatment paradigms for neurodegenerative diseases. By creating cutting-edge therapies like SPG302 and SPG601, aimed at not just alleviating symptoms but also restoring normal synaptic functions, Spinogenix is providing hope to patients facing dire prognoses. As the landscape of ALS treatment evolves, the company’s commitment to innovating therapeutic options showcases a promising future for individuals affected by these debilitating conditions.

For more detailed insights about the ongoing clinical trials or to learn more about the company's commitment to ALS treatments, visit Spinogenix's website.

Contact Information
For media inquiries regarding the EAP or SPG302, reach out to Nechama Rosengarten at FINN Partners or Dan Albosta at Spinogenix, showcasing the company's dedication to transparent communication and patient advocacy.