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Spinogenix's Daily Pill SPG302 Receives FDA IND Nod for ALS Treatment

The FDA has cleared the IND application for SPG302, a novel ALS treatment focusing on synapse regeneration. This once-daily pill aims to improve cognitive and motor functions by restoring neuron connections. SPG302 has shown promise in early trials, receiving support from the NIH and DoD, and is now advancing to further clinical testing with ALS patients.

Spinogenix, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SPG302, marking a pivotal step forward in the potential treatment of Amyotrophic Lateral Sclerosis (ALS). This innovative therapy is designed to regenerate synapses and reverse declines in both cognitive and motor functions in ALS patients.

Novel ALS Treatment

SPG302 represents a revolutionary approach in the fight against ALS, focusing on the regeneration of synapses, the crucial connections between neurons that are central to the disease's progression. Unlike current treatments that merely slow the disease, SPG302 aims to restore lost neural connections, potentially improving patient outcomes dramatically.

Stella Sarraf, Ph.D., CEO and Founder of Spinogenix, expressed enthusiasm about the recent FDA acceptance, noting the completion of Phase 1 safety studies in healthy subjects in Australia. “SPG302’s unique approach to regenerate synapses offers a fundamentally different treatment modality, focusing on synapse loss which is central to ALS," said Sarraf. "Current treatments have not sufficiently met the needs of ALS patients, as slowing disease progression alone is not enough. We are committed to advancing SPG302 with the hope of providing a new, transformative therapeutic.”

Clinical Trials and Endorsements

The drug has already demonstrated promising results in Australian trials, showing excellent tolerability and effective plasma levels in animal models. The ongoing Phase 1/2 study has now moved to include ALS patients, with dosing beginning in April 2024. Further details on the study can be found on (NCT05882695).

Support for the development of SPG302 extends beyond Spinogenix, with endorsements and funding from major institutions including the U.S. National Institutes of Health (NIH) and the Department of Defense (DoD). The drug has also been granted U.S. FDA Orphan Drug Designation for ALS treatment.

Dr. Merit Cudkowicz, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, highlighted the importance of this innovative treatment. “ALS is a complex and varied disease, affecting cognitive and motor functions as well as speech and respiration. Spinogenix’s new approach works at the synaptic level to regenerate synapses. This first study in people with ALS is an important step towards determining whether SPG302 helps recover lost functions in motor and cognitive symptom domains,”  she commented.

About ALS

ALS, or Lou Gehrig’s disease, is a relentless neurodegenerative condition that progressively paralyzes patients, often leading to death by respiratory failure within two to five years of diagnosis. It affects up to 30,000 Americans, with around 5,000 new cases each year. Currently, there is no cure for ALS, which makes the development of treatments like SPG302 all the more critical.


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