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AI Therapeutics Announces Initiation of a Phase II Clinical Trial of AIT-101 for Treatment of ALSGUILFORD, Conn., Jan. 13, 2022 (GLOBE NEWSWIRE) -- AI Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, announced today the initiation of a Phase II study for a promising new approach to treat amyotrophic lateral sclerosis (ALS). ALS, also known as Lou Gehrig’s Disease, is a fatal neurological disorder that affects approximately 30,000 patients in the United States, with an average life expectancy of three to five years. AI Therapeutics’ drug candidate AIT-101 employs a novel approach to clearing toxic protein aggregates that accumulate in the brains of ALS patients and are a hallmark of the disease. “We are excited to have begun our first clinical trial for AIT-101 in ALS patients and are optimistic that it has the potential to change the course of this terrible disease,” said Dr. Murat Gunel, Chair of the Department of Neurosurgery and Professor of Genetics and Neuroscience at Yale University and Chairman of the Scientific Advisory Board of AI Therapeutics. “AIT-101 is a very promising molecule as it is incredibly specific for its target, PIKfyve kinase, and has been safely dosed in hundreds of patients in other clinical trials. The potential therapeutic value for PIKfyve kinase inhibition in ALS and other neurodegenerative diseases was initially predicted by both the AI Therapeutics’ Guardian Angel™ Platform and by our own observations.” “ALS is an ultimately fatal neurodegenerative disease with few effective treatments available. AIT-101 employs a novel approach in aiming to clear the abnormal protein aggregates that lead to motor neuron degeneration,” added Dr. Katharine Nicholson, a neurologist and ALS clinical trialist at the Sean M. Healey Center for ALS at Massachusetts General Hospital in Boston. “The AI Therapeutics trial focuses on ALS patients with the 9orf72 mutation (C9ALS) in whom we can effectively measure the breakdown of proteins specific to the C9 repeat expansion as well as proteins found in all people with ALS. The study is designed to evaluate AIT-101 in this subpopulation of ALS prior to consideration of a larger trial in the broader ALS population, and importantly incorporates access to the drug for all participants.” The 12-week, randomized, placebo-controlled study will enroll 12 patients to evaluate the safety, tolerability, pharmacokinetics, and effect of AIT-101 on biomarkers of target engagement, toxic protein aggregates and neurodegeneration. Functional measures, including the ALSFRS-R (Revised ALS Functional Rating Scale), Vital Capacity and ALS-CBSTM (ALS Cognitive Behavioral Screen), will also be assessed throughout the study. After the initial 12 weeks, all patients will be offered AIT-101 for an additional 12 weeks. Additional information is available at www.clinicaltrials.gov (NCT05163886). About AIT-101 About AI Therapeutics About 4Catalyzer
For further inquiries please contact: [email protected] AI Therapeutics 530 Old Whitfield Street Guilford, CT 06437 |