SEATTLE–(BUSINESS WIRE)– A six-year-old biotech company at the leading edge of regenerative medicine is bringing a therapy for Alzheimer’s to Phase I clinical trials that is expected to slow or stop disease progression as indicated by pre-clinical studies, announced M3 CEO Leen Kawas.
“The launch of our first-in-human clinical trials is a significant step toward realizing M3’s mission to develop affordable therapies that modify neuro-degenerative diseases. Current drugs on the market for Alzheimer’s patients offer only symptomatic relief, whereas we anticipate NDX-1017 will slow, halt and potentially restore lost function,” said Kawas. “The pre-clinical studies suggest we are on the right path, and we are excited to advance a much-needed brain regenerative therapy to alleviate the suffering of millions afflicted by the disease, and their families, around the world.”
Major funding for the trials was provided by the Alzheimer’s Drug Discovery Foundation (ADDF); Dolby Family Ventures, which funds the most innovative Alzheimer’s and brain health therapeutics; and W-Fund, which supports promising spin-outs from Washington-state research institutions.
“We are fortunate to have financial support from these organizations, and we appreciate the many collaborators who have brought us to this important step,” said Kawas. “The exposure to the business and scientific communities provided by the ADDF, and the continued support we received from Dolby Family Ventures, placed us with those who share our commitment to solve this unmet need.”
Phase I clinical trials will be conducted as a randomized double-blinded placebo controlled study focused on the safety and tolerability of NDX-1017. The trial will also explore EEG as a biomarker for investigating brain activity, and target engagement to help determine the optimal dosing range in both healthy adults and mild Alzheimer’s disease patients. Clinical trials will be conducted by Biotrial Inc. in New Jersey, USA, a CNS-focused group with over 25 years of experience in early-phase clinical trials.
About M3 Biotechnology, Inc.
M3 Biotechnology is a clinical stage company with a novel platform of disease-modifying regenerative therapies particularly relevant to neurodegenerative diseases, with a focus on Alzheimer’s. M3’s lead asset, NDX-1017, modifies growth factor systems and is advanced as a first-in-class, disease-modifying treatment with the potential to restore lost connections between brain cells, turning degeneration into regeneration. For information, visit http://www.m3bio.com/.