By Gita Gupta
Last year, we posted about Dr.Robert Naviaux’s success with the 100 year old drug suramin in a small double-blind, placebo controlled trial of children with autism. All the children who received a single dose of suramin showed improvements in the core symptoms of autism. You can read the parent stories of improvements in their children here, but these are some of the improvements that were seen –
· new language
· longer and more complex spontaneous sentences
· improvements in voice quality
· improved appetite
· less picky eating
· interest in trying new things
· greater resilience to changes in routine
· increased social interaction with other children including playing games.
This study was small due to a lack of funding. Funding was entirely from private donations. Larger, carefully designed clinical trials are needed to replicate the results, learn how to use low-dose suramin safely in autism, identify drug interactions as well as detect rare side effects and collect all the data that the FDA requires to approve the use of suramin in autism.
After the success of the initial small trial, we had hoped it would be quick and easy to raise money to fund the path to FDA approval. As some of you know, the road has been much longer and rockier than anyone expected. However, we finally have good news! Read on for an update.
Suramin Autism Trial Update – Q&A with Dr. Naviaux
What is the status of the suramin autism trial(s) – has funding been found? If so, when will the trials start?
Dr.Naviaux: I am very happy to share that a biotech company, backed by very reputable investors with a proven track record, has agreed to make suramin and fund the next autism trials.
Unfortunately, Bayer decided not to provide suramin for the proposed clinical trials in autism. So, the biotech company that will be funding the trials has agreed to manufacture suramin. They will also collect all the data that the FDA needs in order to approve the drug for use in autism.
It will take about a year for suramin to be available from this biotech company. Even factoring in the year that it will take for suramin to be ready, we expect that this will be a much faster and smoother path to FDA approval than attempting to fund each step through charitable donations.
The company will make a public announcement when suramin is available for the next clinical trials. (Per the legal agreement that the Naviaux Lab has with this company, their name cannot be disclosed until then.) The suramin autism treatment 2 (SAT2) trials will start as soon as suramin is available.
We are hopeful that the new supplier of suramin will, in the long run, offer a simpler path forward and fewer potential delays in testing. If future clinical trials show that suramin is safe and effective in treating autism, then the FDA will have all the data they need to make a decision on approval in a shorter period of time than before. Ultimately, this means that the drug can become available for patients with autism or ME/CFS faster than was possible before.
We appreciate your support on the long road we traveled trying to raise funds for this trial. We are very grateful for all your donations, which have helped support the lab while this important agreement was being worked out.
Can you describe the trials that are planned? How many patients, what age, what gender etc.? Will there be a multi-dose trial or just the bigger trial?
Dr.Naviaux: Several clinical trials will be needed. The first two will test a few doses of suramin given monthly for a few months. These will be done in about 50 boys, ages 5-17 years old. The exact ages have not yet been decided. After that, a study will be done that will include girls with ASD. Other studies will look at drug-drug interactions so we know if suramin interacts with drugs that are commonly used in ASD. The last clinical trial that the FDA will need will be a Phase III, multicenter trial in 200 or more participants. The multicenter trial will test the safety and efficacy of several doses of suramin given monthly for several months.
Will suramin be available on a compassionate use basis prior to FDA approval?
Dr.Naviaux: This is not known yet. The safety and efficacy of several doses of suramin must be shown first.
How long will it take to get FDA approval?
Dr.Naviaux: This will depend on the results of the next few studies. In principle, it usually takes about 5 years to complete all the needed studies after the first feasibility study. This would include the time to conduct and analyze the results of the required multicenter, Phase III study. If the next studies showed that suramin was exceptionally safe and effective at the doses used, this time might be decreased by a year or two.
Here’s to smooth sailing ahead
After many roadblocks and funding challenges, we are happy that a path has finally emerged for suramin to be extensively tested in autism! Here’s wishing Dr. Naviaux and his biotech partners a smooth and quick path for testing suramin, and if proven safe and effective, winning the FDA approvals needed to make it widely available to children with autism.
Want to learn more about suramin in autism? Check out the Naviaux Lab page on autism research. http://naviauxlab.ucsd.edu/science-item/autism-research/
Want even MORE info? Watch Dr. Naviaux’s talk on Suramin courtesy of the Brain Foundation.
For more information about Gita Gupta – please see https://www.tacanow.org/about-taca/ambassadors/
Thank you so much for the update. I have been looking for follow on information for many months. I was very disappointed in how little press, enthusiasm and action came from Dr. Naviaux’s study. I wish the time frame for a potential cure was less than the 5 year estimate (possibly sooner), but it is what is. I’m sure Dr. Naviaux has been frustrated by the prolonged process thus far as well.
Your TACa friends are excited! Check back for updates!
This is such good news.
This is very exciting. I was just wondering if there had been any further progress? Thank you.
This is the latest. We will share more once an update is available
We are very excited! Thank you guys for your hard work and effort. You are doing a very good job and you are our super heroes! Wish you a very smoother path ahead. More excited for any updates soon.
Unfortunately this new trial will take longer than expected. Dr. Naviaux will start in fall, so it’s almost another year of waiting… this is really unlucky that a very promising research takes so long….
I’m not sure what you base your statement on. I will share my thoughts too😀
My understanding is this compound will help subgroups at any age.
Research always takes more time than what I would like. But what I do know: Time will pass anyways. I am hopeful that the research can happen faster. All I know is that I have great hope for the future.
Thank you for the information it is greatly appreciated. No word on any possible updates? Any chance to be able to register intererest to be involved in the trial?
We are checking on updates.
With regards to participation in any study you need to contact the university to see if your child is a candidate.
Thank you very much Lisa
Once approved do you foresee individuals being able to use their local physicians to prescribe suramin.
1) if and when it’s approved
2) what it’s approved for
While in the research process those decisions are not made
Will they ever do testing on our older kids? My boys are now almost 23, and most research and clinical trials want only kids in the under 17 crowd. Heck, by the time they hit middle school, they’re pulling most of the services, saying it only works with the younger crowd. Are they planning on trials with the over 18 group?
Studies cost money. Ideally contact the places of interest for your family and ask them about the trials for adults.
Any updates on Suramin study?
The update is coming soon.
Hello, any update? have the research started yet?
Shared a new blog this morning.
Unfortunately I couldn’t make it to the TACA conference due to living overseas. I am hoping TACA may be able to provide an update on Dr Naviaux’s presentation on the upcoming suramin trial? Thank you
Updates to this research can be found here: https://tacanowblog.com/2019/11/04/suramin-research-status/
So glad that this trial is moving to next step. Have been waiting for sol long. You are our hope.
You are the only hope for us, thank you Dr. Robert and all the team for your effort.
Will this SURAMIN only be available in the future of children? No young Adults with Autism as well?
Trials are trials.
Any uodate please? That’s so long??? 😔😔😔
There is a November update on this blog
Hi, do you think that trial is can be postponed due to recent epidemic?
We don’t know. We are in crisis support mode. If and when we have an update they will be shared here.
Support services for families are available at http://www.tacanow.org
Can somebody tell me where to buy suramin please? Europe or USA?
Please take a moment to read the info. Suramin is not commercially available at this time
No updates about new research?
Please read the November update n this blog
I certainly hope things are still on track and moving along for the approval of this drug. I find it highly frustrating that there is not more emphasis on getting this accomplished and in the patient’s hands.
The process is expensive and time consuming. It unfortunately takes time
It’s completely ridiculous as I have told Dr Naviaux publicly and privately for him to exclude girls. We are talking about a medication well studied in men women and children for African sleeping sickness and yet his gender bias of excluding girls will potentially unnecessarily delay their treatment. I can’t support someone who approaches research in a biased non-inclusive manner.
It’s about money. Not exclusion. If there was unlimited resources the work would be done now
How much money does it take to fund a project like this?
Quite a bit. That is a “it varies” response. Parents did fundraisers and private funding happened so this phase could get underway. Now it is underway
Also there’s a link to the lab. You can ask them directly on phase one and phase two costs
07 May 2020: I think part of the reason so many people ask for updates is the lack of DATES on the blog here. Please put a date on each new posting and update!
It’s on the bottom ✅😊
Parents are waiting for good news.
Hello, at what point does the government provide financial support? with autism on the increase and the knowledge that has been gathered then 1/59 children diagnosed with autism is in my eyes a concern for the stability of the future economy. it is this that the governments seem to only care about so why is the projection of the care and cost not put forward as a concern. The structure that is in place to look after the elderly is inadequate so how are they going to adjust for a autism care system as well. I believe with the right marketing and getting this information out to the public (autism can effect any one) then i believe your money issues will be less of a concern.
I had to do some real digging to get to know of this trial and not one parent with a child that is diagnosed with autism has heard of these trials. As said with marketing are you not allowed to get the database of all the people with autism and forward your trial findings.
Why would Bayer decide not to provide suramin for the proposed clinical trials in autism. I find this very outdated attitude to helping so many autistic children and Parents.
I will add mor equestions to this thread at a later point.I look forward to getting reports and following this up as it progresses. I wish you all the best on your trials and that your findings keep moving forward.
we provided a new update on this blog – an interview with Dr. Naviaux. I encourage you to check out the latest information.
How long do we have to wait to have suramin on the market? Please someone tell me…
Please read the update on this blog
Well there’s no positive updates They have been saying the somethings again and again. If the us government wants to find a cure ( drugs) for Autism they will find it in less than a year, but the problem they don’t care, look at them now how they fighting the find vaccine for covid-19.
Please look at the blog for a newer update. This is an older entry
We are living in a hope, praying all the time, and just always wondering? Is Suramin going to be the cure🙏🏻🙏🏻🙏🏻???
Maybe. We have to wait for the next phases of the science. I hope you check out more recent posts for a newer update.
I write this as a mom not a scientists. There are over 30,000 studies on treatments and therapies published since 2005. I have a lot of hope. That’s over 50 a week. There’s a lot you can do now to help your child. Please reach out to TACA for help.
Have their been any updates regarding suramin as a treatment for autism? His blog is four years old with no updates.
We shared an update at the TACA conference in April http://www.tacanow.org
for those that were unable to attend the conference, is there a link to what was presented at the conference regarding the Suramin trials?