Seattle biotech M3 Biotechnology launches in-human clinical trial of therapy expected to slow or stop disease progression.
Regenerative medicine biotech M3 Biotechnology has launched first-in-human trials of its lead asset, NDX-1017, a growth factor system modifier. NDX-1017 has the potential to restore lost connections between brain cells, turning degeneration into regeneration.
Leen Kawas, M3 CEO, said the Phase I clinical trial of NDX-1017 is expected to demonstrate the candidate’s ability to slow or stop disease progression. “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,” he said. “Current drugs on the market for Alzheimer’s patients offer only symptomatic relief,” he explained, “whereas we anticipate NDX-1017 will slow, halt and potentially restore lost function.” Kawas continued that the candidate would be a “much-needed brain regenerative therapy to alleviate the suffering of millions afflicted by the disease, and their families, around the world.”
According to M3, funding for the trials came primarily from the Alzheimer’s Drug Discovery Foundation, (ADDF) Dolby Family Ventures and W-Fund. “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 randomized, double-blind and l[placebo controlled, with a focus on the safety and tolerability. The trial will also explore EEG as a biomarker for investigating brain activity and target engagement to help understand optimal dosing range in healthy and afflicted patients. Trials will be conducted at Biotrial Inc., in New Jersey.
