By Eric Sorensen, WSU science writer
SEATTLE – A neurodegenerative disease drug developed at Washington State University will likely qualify for a federal “fast-track” designation and go into clinical trials next year, said Leen Kawas, CEO of M3 Biotechnology Inc.
Kawas, a co-inventor of the drug with WSU professors Joe Harding and Jay Wright, said the firm will also try to qualify for a “breakthrough” designation.
The U.S. Food and Drug Administration’s fast-track designation is aimed at helping speed the development of drugs “to treat serious conditions and fill an unmet medical need,” according to the agency. The breakthrough designation is for drugs that are a substantial improvement over existing therapies.
The M3 drug, known as MM-201, builds new connections between brain cells. It has been shown to improve the cognitive and motor functions of rats with impairments similar to Parkinson’s disease and Alzheimer’s-like dementias. Clinical trials will aim to see if the drug is safe and effective in humans.
The drug is in the middle of a pre-investigational new drug application, a preliminary step to clinical trials, Harding said last week in a WSU Innovators lecture held in Seattle’s Bell Harbor. Sponsored by the Office of Research, the lecture was attended by about 150 people, one of the larger audiences in the series’ 10-year history.
To learn more about the history and promise of M3 Biotechnology’s drug, read “The Innovators: Designing Medicine’s Holy Grail.”