The ALS Therapy Development Institute (ALS TDI) has received FDA approval to conduct a Phase 2a clinical trial of TDI-132 (fingolimod, Gilenya) for the treatment of amyotrophic lateral sclerosis (ALS).
Fingolimod is currently being marketed by Novartis as Gilenya to treat some forms of multiple sclerosis. The trial will determine the safety and tolerability of TDI-132/Gilenya in people with ALS.
ALS TDI, a non-profit biotech, is the sole funding sponsor of this clinical trial, thanks to the support it received from the ALS community. Current enrollment sites include Massachusetts General Hospital in Boston; University of California, Irvine in Orange; Georgia Health Sciences University in Augusta; and Methodist Neurological Institute in Houston.
“It was exciting to see how expeditious the FDA reviewed our application to test Gilenya in ALS patients,” said Steve Perrin, CEO and CSO, of ALS TDI. “We are eager to start enrolling patients in the clinical trial of TDI-132 and take this important step toward understanding whether or not Gilenya is a potential treatment for ALS.”
The Muscular Dystrophy Association’s “Augie’s Quest,” has contributed in funding the research leading to the advancement of the ALS clinical trial.
ALS TDI researchers first began preclinical testing of TDI-132 in 2011 for its ability to block certain immune cells from entering the brain and spinal cord, where they can cause activities that result in damage to motor neurons. The institute has confirmed that TDI-132 significantly reduces the circulation of these immune cells through the bloodstream, resulting in fewer of them infiltrating into the central nervous system. Further experiments at ALS TDI showed treatment with TDI-132 resulted in positive outcome based on several disease measures in preclinical studies.
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