Patent Approved on Microbiota Transplant Therapy for treating autism spectrum disorder and associated symptoms
Dear Autism Community,
We are pleased to report that the US Patent Office has approved our patent on the use of Microbiota Transplant Therapy (MTT) for treating autism spectrum disorder and associated symptoms. This does not mean that MTT is FDA approved but is an important step forward.
Here is the official patent title and abstract:
Title: Methods for treating autism spectrum disorder and associated symptoms
Abstract
The present disclosure relates to compositions and methods for treating autism spectrum disorder (ASD) by restoring an ASD patient's gut microbiota. These methods can be used with ASD patient with or without ongoing gastrointestinal symptoms. Provided here is a method for ASD treatment in a subject in need thereof comprising or consisting essentially of administering a therapeutic composition comprising a fecal microbe or a fecal microbiota preparation to the subject. Also provided here is a method comprises administering an antibiotic to a human subject; subjecting the human subject to a bowel cleanse; and administering purified fecal microbiota to the human subject. Further provided are evaluation and quantitative characterization of patient symptom improvements upon treatment described here.
The full information on the patent, as well as our list of collaborators, is available on the US Patent Office website at:
https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=11,202,808.PN.&OS=PN/11,202,808&RS=PN/11,202,808
Approval of a patent is important because it means that pharmaceutical companies will be willing to invest tens of millions of dollars to conduct Phase 2 and Phase 3 clinical trials, which are required for FDA approval and release of the treatment to the public. We have licensed the patent to Finch Therapeutics, who have been providing partial support of our research, and they are planning their own clinical trials in mid 2022 (here is a link to their press release on our patent: https://finance.yahoo.com/news/finch-therapeutics-further-strengthens-patent-120000177.html?guccounter=1)
Meanwhile we are continuing our own Phase 2 clinical trials for adults with autism (last participants have started treatment) and children with autism (half of participants have started treatment). These studies will also be important for ultimately winning FDA approval.
So, this is one important step towards our goal of hopefully making this therapy available to everyone with autism, to improve their health and overall quality of life.
Many thanks to the children and adults with autism who have participated in our research studies and clinical trials, the thousands of families who have financially supported our research, and the research grants we have received.
Please note that our rate of progress is limited by our funding, so we welcome donations to support our progress.
Tax-Deductible Donations to support our research can be made to the ASU Foundation:
General Autism-Microbiome research:
Sincerely,
James B. Adams – ASU Autism/Asperger’s Research Program
Rosa Krajmalnik-Brown – Director, Biodesign Center for Health through the Microbiomes at ASU
Autism/Asperger’s Research Program
Arizona State University
father of a daughter with autism
